[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sleep\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sleep":31},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,203,0,25,[9,56,81,107,131,143,173,208,239,263,275,304,326,353,373,411,438,459,486,512,542,563,586,612,637],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":37,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100053319","cbt-i-vs-mbti-for-traumatic-brain-injury-tbi-related-insomnia-and-post-traumatic-stress-symptoms-100053319",false,"NCT05663034","CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms","CoMBat Insomnia: A Randomized Controlled Trial of Cognitive-Behavioral vs. Mindfulness-Based Treatment for TBI-Related Insomnia and Post-Traumatic Stress Symptoms","Inclusion Criteria:\n\n1. Current or former member of the uniform services\n2. Meet the Veterans Affairs Medical Center (VAMC) Department of Defense (DoD) criteria for TBI;\n3. Time duration since traumatic brain injury (TBI) injury \\>90 days\n4. Insomnia symptom duration \\>90 days\n5. Endorse insomnia symptoms (Insomnia Severity Index \\[ISI\\] score \\> 10)\n6. Display sufficient cognitive capacity to provide informed consent (Montreal Cognitive Assessment (MoCA) Z-score \\> -2)\n7. \\>18 years of age\n8. Access to and ability and to use computer.\n\nExclusion Criteria:\n\n1. History of neurological diseases other than TBI and not attributable to TBI\n2. Sleep apnea \\[apnea hypopnea index (AHI) \\>15; individuals with mild apnea (AHI \\> 5 and \\\u003C15) will be informed, but allowed to participate\\]. Participants who use a continuous positive airway pressure (CPAP) device for sleep apnea will be eligible for participation if they are below the apnea\u002Fhypopnea cutoff while using CPAP, are adherent to using the device (\\> 4 hours\u002Fnight 21\u002F30 consecutive days) and agree to continue using the device during study participation.\n3. Lastly, people using psychotropic medications may be included if they are on a stable dosage for the last three weeks prior to the study.","ALL","18 Years",{"count":20,"type":21},360,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study is a prospective two-arm, single blind randomized controlled trial design to compare the clinical effectiveness of telemedicine-delivered, 6-session, standardized cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) in treating insomnia symptoms and ameliorating depressive symptoms in persons with mild to moderate TBI and comorbid Post-Traumatic Stress Symptoms (PTSS) and insomnia symptoms in a 360 patients. Participants will undergo assessment (psychosocial questionnaires, neurocognitive testing, sleep monitoring) at baseline, at the end of treatment, and at 2-, 6- and 12-weeks post-treatment. The primary outcome is sleep as measured by the Insomnia Severity Index (ISI).",[27,28,29,30,31,32,33,34,35,36],"Traumatic Brain Injury","Insomnia","Depression","Post-traumatic Stress","Sleep","Memory Impairment","Cognitive Behavioral Therapy","Concussion, Brain","Head Injury","Brain Injury Traumatic Mild",[27,28,38,29,39,35,40,41,42],"Posttraumatic Stress Symptoms","Concussion","Brain Injury","Cognitive Behavioral Therapy for Insomnia","Mindfulness-based Treatment for Insomnia","RECRUITING","2026-07-10",{"date":46,"type":47},"2026-07-13","ACTUAL",{"date":49,"type":47},"2024-05-10",{"date":51,"type":21},"2027-06",{"name":53,"class":54},"Johns Hopkins University","OTHER",5,{"id":57,"slug":58,"hasResults":12,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":66,"conditions":67,"keywords":68,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":72,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100053375","stress-coping-and-sleep-health-study-100053375","NCT07566481","Stress, Coping, and Sleep Health Study","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in a FGD for this study, an individual must meet all of the following criteria:\n\n1. Adult (aged 18 years or older) living in Ohio, US\n2. Self-identify as Bhutanese-Nepali or Bhutanese American\n3. Identify as a refugee\n4. Speak and understand English and\u002For Nepali.\n5. Ability to understand and the willingness to provide informed consent and participate in the FGD\n\nIn order to be eligible to participate in a KII for this study, an individual must meet all of the following criteria:\n\n1. Adult (aged 18 years or older)\n2. Ability to speak and understand English; Familiarity with the lives and experiences of Bhutanese refugees living in Ohio, US\n3. Ability to understand and the willingness to provide informed consent and participate in the virtual KII.\n\nEXCLUSION CRITERIA:\n\nIndividuals who are unable to communicate in either English or Nepali will be excluded from FGD. Since Nepali is the primary language spoken by most Bhutanese refugees before relocation, and English is the dominant language in the United States, participants are expected to have sufficient proficiency in at least one of these languages.\n\nIndividuals who are unable to communicate in English will be excluded from KII. Given their leadership roles and interactions with the healthcare system, educational institutions, local government service providers, and nonprofit organizations in Ohio-where English is the primary language-participants are expected to have sufficient English proficiency. We will not exclude any participants that meet the inclusion criteria from participating in the study overall or in any of the study procedures.\n\nChildren (individuals under 18) are excluded from this study because the knowledge sought is not relevant to this population. This study investigates the relationship between sleep quality and experiences of discrimination among Bhutanese-Nepali refugees in Ohio, as well as the coping mechanisms adults use to manage discrimination-related stress, particularly as it pertains to sleep.\n\nThe constructs under investigation, including perceived discrimination, its psychosocial impact, and adaptive coping strategies, are anchored in the adult experience of resettlement and the stressors associated with adult social and occupational life. Children's experiences of discrimination, sleep patterns, and coping mechanisms differ substantially from those of adults in both nature and context, and findings from an adult sample would not be generalizable to a pediatric population. For these reasons, the inclusion of children would not yield scientifically meaningful data relevant to the study aims.","120 Years",{"count":64,"type":21},70,"OBSERVATIONAL","Background:\n\nPoor sleep is common among refugee groups worldwide. It can lead to an increased risk of heart disease, diabetes, cancer, and premature death. It can also worsen mental health disorders. Researchers have studied the mental health issues among refugees from Bhutan in the United States. Now they want to understand more about how difficulty sleeping may relate to their other health outcomes.\n\nObjective:\n\nTo learn how the social and environmental conditions Bhutanese refugees affect their sleep health and health outcomes.\n\nEligibility:\n\nRefugees aged 18 years and older of Bhutanese-Nepali or Bhutanese American descent. The participants must live in central Ohio. Also needed are people aged 18 years and older who interact with Bhutanese refugees in this region.\n\nDesign:\n\nParticipants will participate in a focus group discussion. The group will have 8 to 10 participants. It will last 60 to 90 minutes.\n\nThey will talk about their experiences as a refugee and their sleep health. Topics may include adjusting to a new culture; access to housing and health care; and experiences with differential treatment by members inside and outside of their group. The study team will audio record the discussion. They will not share the recording with anyone.\n\nParticipants will complete a short questionnaire. They will answer questions about their age, sex, language preferences, and how long they have lived in the United States.\n\nParticipants who are not refugees will take part in a virtual interview led by a member of the study team. Participants will share their experiences with adapting to a new culture, differential treatment, and other factors have affected refugees sleep. The interview will take about 1 hour.",[31],[69,31,70],"Refugee","Discrimination","NOT_YET_RECRUITING",{"date":46,"type":47},{"date":74,"type":21},"2026-07-16",{"date":76,"type":21},"2026-12-31",{"name":78,"class":79},"National Institute of Environmental Health Sciences (NIEHS)","NIH",1,{"id":82,"slug":83,"hasResults":12,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":17,"minAge":89,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":100,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":80},"100053331","phase-2-sleep-trial-to-prevent-alzheimers-disease-100053331","NCT04629547","Sleep Trial to Prevent Alzheimer's Disease","SToP-AD","Inclusion Criteria:\n\n* Male or female.\n* Any race or ethnicity.\n* Participants must be age ≥65 years and able to sign informed consent.\n* Global Clinical Dementia Rating (CDR) 0.\n* Willing and able to undergo study procedures.\n\nExclusion Criteria:\n\n* History of reported symptoms suggestive of restless legs syndrome, narcolepsy or other central disorder of hypersomnolence, or parasomnia\n* STOP-Bang score \\>6 for participants without PAP\n* Untreated OSA with AHI ≥15 on home sleep test\n* Treated sleep apnea with PAP non-compliance\n\n  * PAP compliance is defined as \\>= 4 hours per night \\>70% of the nights\n* Plasma A-beta and tau test with a plasma p-tau 217% ≤ 1.19\n* Stroke.\n* Chronic kidney disease defined as patients with markers of kidney damage or eGFR of \\\u003C 45 ml\u002Fmin\u002F1.73m2.\n* Hepatic impairment defined as AST and\u002For ALT \\> 2x upper limit of normal (normal limits AST: 11-47 IU\u002FL, ALT: 6-53 IU\u002FL).\n* HIV\u002FAIDS.\n* History of substance abuse or alcohol abuse in the proceeding 6 months.\n* Regular alcohol consumption 3 or more days a week over the last 6 months. Regular alcohol consumption is defined as having more than 2 alcoholic beverages within 3 hours of bedtime. Participants that agree to reduce alcohol consumption during the study may not be excluded.\n* History of presence of any clinically significant medical condition, behavioral or psychiatric disorder, or surgical history based on medical record or participant report that could affect the safety of the participant or interfere with study assessments or in the judgement of the Principal-Investigator (PI) if participant is not a good candidate.\n* Has any medical condition that, in the PI's opinion, could increase risk to the participant, limit the participant's ability to tolerate the research procedures, or interfere with the collection\u002Fanalysis of the data. Potential medical conditions that will be exclusionary at the PI's discretion:\n\n  * Cardiovascular disease requiring medication except for controlled hypertension.\n  * Pulmonary disease.\n  * Type I diabetes.\n  * Neurologic or psychiatric disorder requiring medication.\n  * Tobacco use.\n  * Use of sedating medications.\n  * Use of medications that interact with suvorexant (if cannot be discontinued)\n  * Abnormal safety labs\n* History of current suicidal ideations.\n* Currently pregnant or breast-feeding.\n* In the opinion of the PI, the participant should be excluded due to an abnormal physical examination.\n* Must not have participated in any clinical trial involving a study drug or device within the 30-days prior to study enrollment.\n* Must not participate in another drug or device study prior to the end of this study participation.\n\nExclusion criteria for optional lumbar punctures\n\n-• Contraindication to lumbar puncture (anticoagulants; bleeding disorder; allergy to lidocaine or disinfectant; prior central nervous system or lower back surgery).",true,"65 Years",{"count":91,"type":21},120,[93],"PHASE2","The purpose of this study is to determine if treatment with the sleep aid suvorexant can decrease the rate of amyloid-β (Aβ) accumulation in the brain.",[31,96],"Alzheimer Disease",[98,99,28],"poor sleep","Amyloid-Beta",{"date":46,"type":47},{"date":102,"type":47},"2022-05-25",{"date":104,"type":21},"2028-05",{"name":106,"class":54},"University of Minnesota",{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":4},"100054105","phase-4-effects-of-melatonin-on-sleep-architecture-of-critically-ill-patients-in-the-icu-100054105","NCT07691996","Effects of Melatonin on Sleep Architecture of Critically Ill Patients in the ICU","Inclusion Criteria:\n\n* 18 years or older, admitted to the ICU\n* Expected length of stay of at least 48 hours\n* Not mechanically ventilated\n* Able to take oral medications.\n* Hemodynamically stable as determined by the treating ICU physician\n* Able to provide informed consent or have consent provided by a legally -authorized representative.\n\nExclusion Criteria:\n\n* Mechanically ventilated\n* Currently using melatonin prior to ICU admission,\n* Have neurological conditions that may significantly alter sleep architecture, such as traumatic brain injury, stroke, or severe dementia.\n* Pregnant or lactating individuals\n* Those individuals with a comfort measures-only status",{"count":114,"type":21},30,[116],"PHASE4","This is a pilot study to examine the effects of melatonin on the sleep patterns of critically ill patients. Patients will have their sleep patterns measured with a device attached to their head with a headband then be given a dose of melatonin. Their participation in the study will last two days.",[119,120,121,122,31],"Critical Illness","ICU","ICU Hospitalization","Melatonin","2026-07-09",{"date":46,"type":47},{"date":126,"type":21},"2026-09-01",{"date":128,"type":21},"2028-01",{"name":130,"class":54},"Rutgers, The State University of New Jersey",{"id":132,"slug":4,"hasResults":12,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":62,"enrollmentInfo":133,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":66,"conditions":134,"keywords":135,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":142,"locationsCount":80},"100636499",{"count":64,"type":21},[31],[69,31,70],"2026-07-01",{"date":138,"type":47},"2026-07-02",{"date":140,"type":21},"2026-07-07",{"date":76,"type":21},{"name":78,"class":79},{"id":144,"slug":145,"hasResults":12,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":12,"sex":17,"minAge":151,"maxAge":152,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":156,"conditions":157,"keywords":160,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":80},"100629612","differences-in-rest-emotion-and-arousal-modulation-in-youth-100629612","NCT07476937","Differences in Rest, Emotion, and Arousal Modulation in Youth","Probing the Role of Sensory Regulation in Sleep Health and Emotion Dysregulation for Autistic Youth","DREAMY-Autism","Inclusion Criteria:\n\n1. Youth between the ages of 6 and 10 years old\n2. Caregiver-reported autism diagnosis and \\>11 on Social Communication Questionnaire\n3. Caregiver-reported bedtime resistance (\\>12 on Children's Sleep Habits Questionnaire-Autism; Sleep Initiation subscale - 3-point scale, 6 questions)\n4. Caregiver willing to participate in all bedtimes during study\n5. Stable medication use (e.g., no changes within 2 weeks)\n\nExclusion Criteria:\n\n1. Participants will be excluded if they do not understand English or are unable to travel to the lab (Pittsburgh, PA).\n2. Concurrent diagnosis of sleep apnea, narcolepsy, or major psychiatric disorder (e.g., major depression, bipolar).\n3. Unstable medication use (dose or timing).\n4. Current behavioral treatment for sleep disorder","6 Years","10 Years",{"count":154,"type":21},60,[24],"The goal of this study is to examine the relationship between sensory responsivity, bedtime arousal levels, sleep disturbances, and daytime emotion dysregulation for autistic children (ages 6-10). In a subset of children with elevated sensory responsivity, a sensory-based bedtime manipulation targeting bedtime arousal levels will be tested.",[158,159,31],"Autism","Sleep Disturbances in Children",[161,162,163,31,164],"Sleep disturbances","Emotion Dysregulation","Sensory Processing","autism","2026-06-30",{"date":138,"type":47},{"date":168,"type":47},"2026-06-01",{"date":170,"type":21},"2030-08",{"name":172,"class":54},"University of Pittsburgh",{"id":174,"slug":175,"hasResults":12,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":88,"sex":17,"minAge":18,"maxAge":180,"enrollmentInfo":181,"targetDuration":4,"studyType":22,"phases":183,"briefSummary":184,"conditions":185,"keywords":189,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":80},"100644966","chronotype-alignment-and-time-perception-100644966","NCT07677111","Chronotype Alignment and Time Perception","Circadian Match and Mismatch Effects on Temporal Cognition in Morning- and Evening-Type Adults","Inclusion Criteria:\n\n* Healthy adult, 18-40 years\n* Clear morning-type or evening-type on the Morningness-Eveningness Questionnaire (MEQ-SA); intermediate types excluded (state exact cut-offs, e.g. evening-type 41 or below, morning-type 59 or above)\n* Normal or corrected-to-normal visual acuity\n* Normal colour vision (e.g. Ishihara screening)\n* Fluent in the testing-site language (Danish, Chinese, or English)\n* Able to attend both an early-morning (about 08:00) and a late-evening (about 22:00) session\n\nExclusion Criteria:\n\n* Intermediate chronotype (MEQ in the middle band)\n* Night or rotating shift work in the past 3 months, or recent trans-meridian travel (more than 2 time zones in the past 4 weeks)\n* Diagnosed sleep disorder (e.g. insomnia, sleep apnoea)\n* Current psychiatric or neurological disorder\n* Use of sleep medication or psychoactive or CNS-active drugs\n* Colour-vision deficiency\n* Substance-use disorder","55 Years",{"count":182,"type":21},240,[24],"People differ in chronotype - whether they function best in the morning (\"larks\") or the evening (\"owls\"). This study asks whether the match or mismatch between a person's chronotype and the time of day at which they are tested changes how they perceive time.\n\nHealthy morning-type and evening-type adults at three sites (Aarhus, Denmark; Changzhou, China; and Hong Kong) complete the same battery of perception and cognition tasks twice - once in the early morning (about 08:00) and once late in the evening (about 22:00), in counterbalanced order. The primary outcome is the accuracy (signed bias) of time-perception judgements; the key comparison is the interaction between chronotype and time of day (the \"synchrony effect\").\n\nSecondary measures include timing precision, the subjective passage of time, sleepiness, mood, colour perception (with and without blue-blocking glasses) and perceptual decision-making. By testing the same protocol across three cultures and latitudes, the study examines whether circadian match\u002Fmismatch effects on temporal cognition generalise across populations.",[186,187,31,188],"Chronotype","Circadian Rhythm","Time Perception",[190,191,192,193,194,195,196,197,198,199],"chronotype","morningness-eveningness","synchrony effect","time perception","temporal cognition","circadian rhythm","time-of-day","duration discrimination","arousal","cross-cultural","2026-06-29",{"date":165,"type":47},{"date":203,"type":47},"2025-09-01",{"date":205,"type":21},"2028-06-30",{"name":207,"class":54},"The Hong Kong Polytechnic University",{"id":209,"slug":210,"hasResults":12,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":88,"sex":17,"minAge":215,"maxAge":216,"enrollmentInfo":217,"targetDuration":4,"studyType":22,"phases":218,"briefSummary":219,"conditions":220,"keywords":224,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":232,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":80},"100596464","body-awareness-therapy-in-high-stressed-young-adults-effects-on-function-balance-sleep-and-mood-100596464","NCT07045792","Body Awareness Therapy in High Stressed Young Adults: Effects on Function, Balance, Sleep and Mood","Investigating the Effects of Body Awareness Therapy on Functional Capacity, Balance, Sleep Quality and Psychological State in Young Adults With High Stress Levels: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Be between 20 and 30 years old\n* Be literate\n* Score 10 or above on the stress subscale of the Depression Anxiety Stress Scale -21\n* Be willing to participate in the study voluntarily\n\nExclusion Criteria:\n\n* Individuals with orthopedic, neurological, rheumatological, psychiatric, mental, or any systemic chronic diseases\n* Those with cardiac problems that may prevent exercise\n* Those suspected of being pregnant\n* Individuals with malignancy\n* Individuals with active infection\n* Those who do not regularly attend the treatment program","20 Years","30 Years",{"count":114,"type":21},[24],"Body Awareness Therapy (BAT) is a holistic approach to human movement that considers the physical, physiological, psychological, and existential aspects of human existence. This planned randomized controlled study will be conducted on young adults with high stress levels. One group will be subjected to BAT and the other group will be the control group. The BAT exercises will be performed in supine, sitting and standing positions. In the BAT group, the exercises will be performed as a group exercise, not individually. After the initial evaluations in both the BAT and control groups, a re-evaluation will be performed at the end of 8 weeks. Functional capacity will be assessed with the 6-minute walk test, static balance with the single-leg balance test (eyes open-eyes closed), dynamic balance with the Y-balance test, psychological status with the Depression-Anxiety-Stress Scale-21 (DASS-21), and sleep quality with the Pittsburgh Sleep Quality Scale. BAT will be performed 2 days per week for 8 weeks and will be continued progressively. This study will examine the effects of BaT on functional capacity, balance, sleep quality, and psychological state in young adults with high stress levels.",[221,222,31,223],"Stress","Psychological Factors","Postural Balance",[225,226,227,228,229,230,231,223],"Body Awareness Therapy","Stress Levels","Psychological Stress","Balance","Sleep Quality","Functional Capacity","Physical Therapy",{"date":136,"type":47},{"date":234,"type":47},"2025-05-30",{"date":236,"type":21},"2026-06-28",{"name":238,"class":54},"Mustafa Kemal University",{"id":240,"slug":241,"hasResults":12,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":245,"eligibilityCriteria":246,"healthyVolunteers":12,"sex":247,"minAge":215,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":250,"conditions":251,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":4},"100644996","health-body-composition-and-nutrition-research-among-women-in-kazakhstan-100644996","NCT07675486","Health, Body Composition, and Nutrition Research Among Women in Kazakhstan","Understanding Women's Health in Kazakhstan: Body Composition as a Key Indicator for Precision Nutrition and Predictive Healthcare","HER-KZ","Inclusion Criteria:\n\n* Female sex\n* Age ≥20 years at the time of consent\n* Natural postmenopause (≥12 consecutive months of amenorrhoea not attributable to other pathological or pharmacological causes) OR surgical postmenopause (bilateral oophorectomy)\n* Resident of Astana or the surrounding region with no planned relocation during the study period\n* Able to provide written informed consent independently\n* Able to complete the questionnaire in Kazakh, Russian, or English\n\nExclusion Criteria:\n\n* Active malignancy or systemic anti-cancer treatment (chemotherapy, radiotherapy, immunotherapy) within the past 5 years\n* Conditions causing secondary changes in muscle mass or body composition: hyperthyroidism (untreated), Cushing's syndrome, acromegaly, severe liver disease (Child-Pugh B or C), advanced chronic kidney disease (Stage 4 or 5, eGFR \\\u003C30 ml\u002Fmin\u002F1.73 m²)\n* Neuromuscular disorders that independently affect skeletal muscle mass (e.g., myopathy, motor neurone disease, multiple sclerosis)\n* Long-term systemic corticosteroid therapy (\\>3 months in the past year, equivalent to ≥5 mg\u002Fday prednisolone)\n* Severe skeletal deformity (kyphoscoliosis, limb absence) or presence of metallic implants (hip or knee prosthesis on both sides, bilateral rods) that would significantly compromise DEXA body composition validity\n* Physical inability to stand or to complete the functional assessments safely\n* Cognitive impairment or psychiatric condition precluding independent informed consent, as determined by the recruiting research team member","FEMALE",{"count":249,"type":21},200,"This study aims to investigate the association between dietary intake, physical activity, sleep quality, and body composition in women in Kazakhstan. The study will recruit approximately 200 women aged 20 years and older undergoing routine DEXA examinations in Astana. Participants will complete validated questionnaires assessing diet, physical activity, sleep quality, and sarcopenia risk, alongside functional assessments. DEXA scans will provide measurements of fat mass, lean mass, visceral adipose tissue, bone mineral density, and appendicular skeletal muscle mass. The primary objective is to evaluate associations between dietary quality and DEXA-derived outcomes. Secondary objectives include assessing sarcopenia prevalence and examining relationships between physical activity, sleep quality, supplement use, and body composition. An optional second stage will explore associations between body composition and existing inflammatory and metabolic biomarkers from medical records. The findings are expected to provide the first comprehensive DEXA-based dataset on women's body composition and lifestyle factors in Kazakhstan and inform public health strategies.",[252,253,31,254],"Body Composition Changes","Dietary Intakes","Physical Activity","2026-06-26",{"date":165,"type":47},{"date":258,"type":21},"2026-07",{"date":260,"type":21},"2029-07",{"name":262,"class":54},"Nazarbayev University",{"id":264,"slug":4,"hasResults":12,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":17,"minAge":89,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":22,"phases":266,"briefSummary":94,"conditions":267,"keywords":268,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":271,"completionDateStruct":272,"leadSponsor":273,"locationsCount":80},"100410825",{"count":91,"type":21},[93],[31,96],[98,99,28],"2026-06-25",{"date":165,"type":47},{"date":102,"type":47},{"date":104,"type":21},{"name":274,"class":54},"Washington University School of Medicine",{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":281,"eligibilityCriteria":282,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":283,"enrollmentInfo":284,"targetDuration":4,"studyType":22,"phases":286,"briefSummary":287,"conditions":288,"keywords":290,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":4},"100644708","phase-4-sleep-outcomes-and-multidimensional-assessment-with-antiretroviral-therapy-in-people-living-with-hiv-on-dolutegravir--vs-doravirine-based-regimens-100644708","NCT07673965","Sleep Outcomes and Multidimensional Assessment With Antiretroviral Therapy in People Living With HIV on Dolutegravir- vs Doravirine-Based Regimens","Multidimensional Sleep Health in PLWH on DTG- vs DOR-Based ART: A Mixed-Methods Pilot Study","SOMNART","Inclusion Criteria:\n\n\\-\n\nEach participant must meet all the following criteria to be enrolled in this study:\n\n1. Male or female aged 18-40 years\n2. HIV-positive\n3. Virologically suppressed, defined as HIV RNA \\\u003C50 copies\u002FmL\n4. No known history of HIV treatment failure\n5. On a stable first-line ART regimen for ≥ 12 months and TDF\u002F3TC\u002FDTG for ≥ 6 months prior to enrolment\n6. BMI \\\u003C 35 kg\u002Fm² and weight \\>35kg\n7. Women of childbearing potential must have a negative pregnancy test at screening, must use acceptable contraception throughout the study, and must not be planning pregnancy during the study period\n8. Willing and able to undergo overnight PSG as required by the protocol\n9. Clinically stable with no uncontrolled comorbidities as assessed by the investigator\n10. Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n\\-\n\nParticipants meeting any of the following criteria will be excluded from the study:\n\n1. Planned or recent (30 days before enrolment) changes to chronic medication, or anticipated medication changes during the study period, if applicable\n2. Known contraindication to Delstrigo (hepatic impairment, hypersensitivity, strong CYP450 inducers)\n3. Previous NNRTI use or prior documented NNRTI mutations\n4. Clinical suspicion of TB\n5. Insufficient total sleep time on screening polysomnography to permit reliable interpretation of sleep parameters or to confirm or exclude a sleep disorder.\n6. Evidence of a clinically significant sleep disorder at screening, based on history, the site-specific Sleep Disorders Screening Tool (SDST) and\u002For polysomnography, including but not limited to:\n\n   1. Suspected or confirmed OSA\n   2. Suspected or known insomnia\n   3. Suspected restless legs syndrome (RLS), or periodic limb movements on PSG\n   4. Narcolepsy\n7. Use of medications known to significantly alter sleep, including (but not limited to):\n\n   1. Benzodiazepines\n   2. Non-benzodiazepine sedative-hypnotics\n   3. Antipsychotics or mood stabilisers\n   4. Antidepressants with significant sedating effects\n   5. Isoniazid\n   6. Anticonvulsants e.g. carbamazepine, phenytoin, phenobarbital\n8. Current alcohol use disorder or substance use (including illicit substances) that may interfere with sleep or study assessments, as determined by the investigator.\n9. Pregnant, breastfeeding, or planning to become pregnant during the study period, or currently nursing or caring for an infant younger than 6 months at home\n10. Active psychiatric illness that might interfere with study procedures or overnight assessments, as assessed by the investigator\n11. Regular shift work defined as working more than three nights or rotating shifts per month at baseline or during the study, or having transitioned from night-shift to day-shift duties within the past month\n12. Known or suspected significant neurological conditions that may interfere with sleep (e.g., epilepsy, neurodegenerative disorders, or a history of moderate-to-severe traumatic brain injury).\n13. Current participation in another clinical trial, observational or interventional","40 Years",{"count":285,"type":21},40,[116],"In South Africa, antiretroviral therapy (ART) has transformed HIV into a chronic, manageable condition, with high rates of viral suppression. As people living with HIV (PLWH) live longer, HIV care is increasingly focused on long-term health, quality of life, and prevention of non-communicable diseases such as obesity,cardiovascular disease, and metabolic disorders, which are increasingly common in this population. Sleep disturbance is highly prevalent among PLWH but is under-recognised in routine care. Poor sleep has been associated with adverse cardiometabolic, cognitive, and functional outcomes, yet is rarely systematically assessed in HIV programmes. Most existing evidence relies on subjective measures, with limited objective polysomnography data, particularly in African populations. In addition, the impact of different ART regimens on sleep health remains poorly understood. This study aims to evaluate and compare sleep health in virologically suppressed PLWH who switch from a dolutegravir-based regimen to a doravirine-based regimen versus thosewho remain on dolutegravir-based therapy. Sleep will be assessed using a multidimensional approach, incorporating polysomnography, actigraphy, and validated patient-reported outcome measures aligned with the RU-SATED framework. The study is particularly relevant in South Africa, where dolutegravir-based regimens are widely used and where obesity and metabolic disease are increasing. In a resource-limited setting where sleep disorders are often underdiagnosed, this study will generate locally relevant evidence on the relationship between ART and sleep health, with potential implications for more holistic HIV care.",[289,31],"HIV (Human Immunodeficiency Virus)",[291,292,293,294,295],"Delstrigo:","Sleep Health","Sleep Architecture","Antiretroviral Therapy","HIV","2026-06-24",{"date":200,"type":47},{"date":299,"type":21},"2026-08-20",{"date":301,"type":21},"2027-11-30",{"name":303,"class":54},"University of Witwatersrand, South Africa",{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":310,"targetDuration":4,"studyType":22,"phases":312,"briefSummary":313,"conditions":314,"keywords":316,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":319,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":80},"100567700","effects-of-osteopathic-manipulative-treatment-protocol-on-sleep-quality-in-parkinsons-disease-subjects-100567700","NCT06671600","Effects of Osteopathic Manipulative Treatment Protocol on Sleep Quality in Parkinson's Disease Subjects","Inclusion Criteria:\n\n* Must have a diagnosis of Parkinson's disease as per a neurologist\n* Severity of 0-3 on the Hoehn and Yahr (H-Y) Scale\n* Able to receive OMM\n* Able to be in a supine and prone position.\n* Able to wear a Fitbit watch and an oxygen saturation ring for the duration of the study (including when sleeping).\n* Have sleep disturbance complaints.\n\nExclusion Criteria:\n\n* Patients on medications that affect sleep\n* Have a pre-existing sleep disorder diagnosis\n* Those who have a concurrent neurological diagnosis that would confound sleep patterns (ie. narcolepsy)\n* Contraindications to the OMM techniques used in this protocol\n* Severity of 4 and 5 on the Hoehn and Yahr Scale",{"count":311,"type":21},32,[24],"Parkinsonism, mainly caused by Parkinsons disease (PD), includes symptoms like tremors, stiffness, slow movements, and balance problems. These symptoms can make it hard for people to sleep well, which leads to a lower quality of life and can increase the risk of other health issues and cognitive decline.\n\nOsteopathic manipulative treatment (OMT) is a hands-on approach that may help improve sleep without the side effects of traditional treatments. While OMT has shown promise in enhancing sleep, no studies have specifically looked at its effects on sleep in Parkinson's disease patients.\n\nThis study aims to see if OMT can help improve sleep quality, cognitive function, and daily activities for people with PD. The investigators will focus on treating specific areas of the body, using techniques that have helped improve sleep in the past.\n\nParticipants will be divided into two groups: one will receive OMT, while the other will get a light touch treatment as a control. Sleep surveys and data from Fitbit devices will be used to compare the effects of the two treatments. Additionally, cognitive function will be assessed using a specific task called the Stroop task.\n\nThis research could show that OMT can be a valuable addition to treatments for improving sleep quality in people with Parkinsons disease.",[315,31],"Parkinsons Disease",[317,31,315,318],"OMM","Osteopathy",{"date":200,"type":47},{"date":321,"type":47},"2025-08-01",{"date":323,"type":21},"2027-12-31",{"name":325,"class":54},"New York Institute of Technology",{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":330,"acronym":331,"eligibilityCriteria":332,"healthyVolunteers":12,"sex":17,"minAge":333,"maxAge":334,"enrollmentInfo":335,"targetDuration":4,"studyType":22,"phases":337,"briefSummary":338,"conditions":339,"keywords":341,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":346,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":80},"100510283","phase-4-daridorexant-to-treat-insomnia-in-patients-with-mild-cognitive-impairment-and-mild-to-moderate-alzheimer-disease-100510283","NCT05924425","Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease","DARIDOR-ALZ","Inclusion criteria :\n\n* Age \\[60-85\\] years old\n* Outpatients\n* Pre-screening:\n\n  * Complaints of dissatisfaction with sleep quantity or quality, despite adequate opportunity for sleep, at least 3 nights per week and for at least 3 months, and\n  * Total sleep time causes clinically significant distress or impairment in daytime functioning, and\n  * Total sleep time estimated by interview was below 6 hours, on at least 3 nights per week and for at least 1 month before screening\n* Baseline PSG (at randomization) assessed TST \\\u003C 6 hours and WASO \\> 1 hour\n* Diagnosis of MCI and AD patients at an early stage according to the NIA diagnosis criteria (core clinical criteria for MCI, positive CSF Aβ42 and\u002For positive plasma biomarker, and neuronal injury (hippocampal and\u002For temporal atrophy by MRI))\n* MMSE from 12 to 26\n* Clinical Dementia Rating CDR from 0.5 to 2\n* Use of CNS-active medications is permitted provided the dose has been stable for at least 3 months, including: anticholinesterase drugs (rivastigmine, donepezil, galantamine) or memantine, antidepressants SSRI (e.g. fluoxetine, sertraline, paroxetine…), SNRI (e.g. venlafaxine, duloxetine), neuroleptics (e.g. clozapine, olanzapine, aripiprazole...) or drug for pain level 2 (codeine, tramadol).\n* For a male subject who is not sterilized and is sexually active with a female partner of childbearing potential, no contraceptive methods are needed\n\nNon inclusion criteria :\n\n* Patients significantly dependent on caregivers\n* Institutionalized patients\n* Analphabetism or subjects unable to read or\u002Fand write\n* Patients unable to perform the neuropsychological tests\n* Patients unable to complete the study instruments (sleep diary)\n* Planned longer stay outside the region that prevents compliance with the visit schedule\n* Patients who cannot be followed up for at least 2 months\n* History of narcolepsy and\u002For cataplexy\n* History of drug or alcohol abuse or addiction\n* History of diagnosed and characterized psychiatric disorders (DSM-5), cured or stabilized (with or without the same treatment for at least 3 months) and excluding any current characterized psychiatric disorder (DSM-5), the diagnosis of which is established by a psychiatrist trained in geriatric psychiatry\n* Moderate and severe liver failure\n* PSG baseline evidence of significant\u002Fsevere sleep-related breathing disorder (defined as \\>30 apnea\u002Fhypopnea episodes per hour)\n* Treatments interfering with sleep-wake patterns\n* Use of hypnotics (benzodiazepines, zolpidem, zopiclone) or drug for pain level 3 (morphine and derivatives)\n* Hypersensitivity to the active substance or to any of the excipients listed in the Summary of Product Characteristics (SmPC)\n* Forbidden and restricted concomitant medications:\n\n  * Concomitant CNS-depressant medicinal products\n  * CYP3A4 inhibitors\n  * CYP3A4 inducers\n* Participation in another clinical trial or administration of an investigational product\n* Protected population according to articles of the French Public Health Code (e.g. patients under law protection, prisoners, pregnant, parturient or lactating women, and patients under guardianship\u002Fcuratorship).\n* Subjects not covered by public health insurance\n* Failure to obtain written informed consent after a reflection period","60 Years","85 Years",{"count":336,"type":21},62,[116],"DARIDOR-ALZ is a phase IV clinical trial designed to evaluate both the efficacy and safety of daridorexant, a selective dual orexin receptor antagonist that blocks the actions of the orexin neuropeptides at both orexin-1 and orexin-2 receptors, in selected populations of MCI and mild-to-moderate AD patients with insomnia complaints.",[96,340,31],"Insomnia Disorder",[342,343,344,345,31,28],"Orexin","Daridorexant","Cognition","Alzheimer",{"date":269,"type":47},{"date":348,"type":47},"2024-03-13",{"date":350,"type":21},"2028-03-13",{"name":352,"class":54},"University Hospital, Montpellier",{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":12,"sex":17,"minAge":360,"maxAge":18,"enrollmentInfo":361,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":362,"conditions":363,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":368,"completionDateStruct":369,"leadSponsor":371,"locationsCount":80},"100644743","postoperative-pain-after-pediatric-adenotonsillectomy-with-ketorolac-or-ibuprofen-100644743","NCT07672418","Postoperative Pain After Pediatric Adenotonsillectomy With Ketorolac or Ibuprofen","Assessment of Postoperative Pain Outcomes Following Pediatric Adenotonsillectomy and the Impact on Non-Steroidal Anti-Inflammatory Drugs","Inclusion Criteria:\n\nScheduled for outpatient adenotonsillectomy Age 13-18 years ASA physical status I-III Patient or parent has access to a phone with text-messaging capability Patient assent Parent or legal guardian consent\n\nExclusion Criteria:\n\nInpatient admission or planned 23-hour observation Known hematologic condition or prior bleeding disorder Current anticoagulant use Known or suspected chronic kidney disease or solitary kidney Known or suspected liver disease or prior liver transplant Known or suspected mitochondrial disease or genetic anomaly Inability to self-report pain History of gastrointestinal ulcer or bleeding Allergy to acetaminophen, ibuprofen, or ketorolac Non-English or non-Spanish speaking Chronic pain or condition requiring frequent routine NSAID use Patient refusal Parent or guardian refusal","13 Years",{"count":249,"type":21},"This prospective observational study will evaluate postoperative pain after outpatient pediatric adenotonsillectomy in adolescents prescribed either acetaminophen with ibuprofen or acetaminophen with oral ketorolac after discharge, based on the prescribing preference of the otolaryngology surgeon. Participants will complete text-message surveys after discharge to assess pain severity, medication administration, and functional recovery for up to 14 days.",[31,364,365],"Pediatrics","Adenotonsillectomy","2026-06-23",{"date":200,"type":47},{"date":296,"type":21},{"date":370,"type":21},"2027-06-30",{"name":372,"class":54},"Baylor College of Medicine",{"id":374,"slug":375,"hasResults":12,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":4,"eligibilityCriteria":379,"healthyVolunteers":88,"sex":17,"minAge":360,"maxAge":4,"enrollmentInfo":380,"targetDuration":4,"studyType":22,"phases":381,"briefSummary":382,"conditions":383,"keywords":396,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":403,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":407,"locationsCount":410},"100644951","the-impact-of-enhanced-music--natural-visuals-on-emotional-health-100644951","NCT07676110","The Impact of Enhanced Music & Natural Visuals on Emotional Health","Impacts of Music, Audio Enhancements, Audio Guidance, and Visuals on Physical and Emotional Well-being. (Emotional Health - Longitudinal 1 Randomized, Controlled Multi-center Study)","Inclusion Criteria:\n\n* You are 13 years of age or older\n* You can read, write, and speak English at a 5th-grade level or higher\n* You are legally capable of providing informed consent (adult participants) or capable of providing assent (child participants)\n* To the best of your knowledge, you are willing and able to commit to the session(s) and activities of this study\n* You are willing and able to use the sound-delivery and data-collection apparatus of this study\n* You are willing to use your own personal equipment. Depending on the study, you may need to have your own ear buds\u002Fheadphones and\u002For a \"smart\" device with internet and\u002For Bluetooth access (e.g., smartphone, iPad).\n* You have normal hearing in both ears.\n* You never experience ringing noises or buzzing sensations in your ears (tinnitus)\n* You do not use a heart\u002Fcardiac pacemaker and do not have any history of cardiac rhythm disturbances, such as cardiac conduction delays or blocks\n* You have no known history of fainting, fainting, spells or seizures, spinning sensations, or trouble with balance (medical terms include epilepsy, seizures, syncope, vertigo, nystagmus)\n* You do not use of any of the following medications: Beta blockers, steroids, ephedrine, acute anti-anxiety medication (e.g., benzodiazepines such as diazepam\u002FValium, lorazepam\u002FAtivan or clonazepam\u002FKlonopin), or acute or chronic pain medications (including narcotics and codeine)\n* For any study session, you will not be under the influence of any substances that could prevent safe participation and will not have consumed e.g., alcohol, THC, Psilocybin, or other mood-altering drugs in the 12 hours preceding the session.\n\nExclusion Criteria:\n\n\\-",{"count":249,"type":21},[24],"The investigators are conducting research on factors related to the self-regulation of mood and arousal states across a range of everyday activities as well as different levels of stress. Behavioral interventions-such as meditation, listening to music, or visualizing art or nature-offer important alternatives and\u002For adjunctive strategies to pharmaceutical tools or other mechanisms supporting physical and emotional well-being. This research will expand on the knowledge base regarding the impact of biophysical stimulation and\u002For frame of mind on an individual's self-directed management of physical and emotional health. Motivation, confidence, and composure are critical aspects of self-efficacy, framing a person's mindset to make healthy choices across daily activities.\n\nThe research in this protocol is carried out across multiple sites and studies by means of digital tools and a consistent participant experience workflow. Together, these resources are intended to support individuals across multiple self-directed experiences utilized in the maintenance of their basic health. Before, during, and after session experiences, the participant provides objective (physiological) responses and\u002For subjective (self-report) responses and reflections; some studies also include interviews or focus groups. The combined set of responses can be summarized, connected to other measures, and input to machine learning models to improve personalization of stimuli. By studying the effects of soundBrilliance experiences across a variety of contexts and participant samples, the investigators can better refine each element of the stimulus to improve satisfaction, tolerance, and targeted outcomes.",[384,385,386,387,388,389,390,31,391,392,393,394,395],"Emotion Management Skills","Lifestyle, Healthy","Lifestyle Intervention","Recovery","Exercise and Recovery","Exercise Training","Anxiety and Mood Disorders","Motivation","Comfort","Pain Management","Rehabilitation","Creativity and Mindfulness",[397,398,399,400,401,402],"Music","Visuals","Visual Imagery","Biophysical Stimuli","Emotional Health","Emotional Management",{"date":165,"type":47},{"date":405,"type":47},"2026-05-25",{"date":51,"type":21},{"name":408,"class":409},"soundBrilliance LLC","INDUSTRY",3,{"id":412,"slug":413,"hasResults":12,"nctId":414,"briefTitle":415,"officialTitle":415,"acronym":416,"eligibilityCriteria":417,"healthyVolunteers":12,"sex":17,"minAge":418,"maxAge":4,"enrollmentInfo":419,"targetDuration":4,"studyType":22,"phases":420,"briefSummary":421,"conditions":422,"keywords":424,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":430,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":80},"100617339","i-slept-integrated-sleep-and-life-engagement-program-for-transitions-100617339","NCT07317336","I-SLEPT: Integrated Sleep and Life Engagement Program for Transitions","I-SLEPT","Inclusion Criteria:\n\n* Admitted to and discharged from VA Boston Community Living Center subacute rehabilitation\n* English-speaking\n* Discharged to a home setting\n* Has capacity and does not have severe cognitive impairment\n* Obtains a score \\>= 8 on the Brief Interview for Mental Status (BIMS)\n* Endorses at least 2 items as \"Rarely\u002FNever\" or \"Sometimes\" on the RuSATED measure AND\u002FOR endorses they are achieving their goals at a \"much worse\" or \"a little worse\" level on the What Matters Most Tool.\n\nExclusion Criteria:\n\n* Discharged from Long-Term Care, Hospice and Palliative Care, or Spinal Cord Injury bed specialty\n* Moderate to severe dementia diagnosis, delirium, or active psychosis\n* Healthcare proxy is activated in electronic health record\n* A diagnosis of a disorder of hypersomnolence, non-REM parasomnia, or Nightmare Disorder as indicated in electronic health record\n* High acute risk for suicide","50 Years",{"count":154,"type":21},[24],"Sleep is essential to functional recovery in rehabilitation settings; however, sleep is likely to be disrupted during rehabilitation admissions. Adverse effects of these disruptions do not subside after discharge, leading to additional consequences such as poor physical function. Veterans are particularly impacted by poor sleep and medical complexities that can lead to injuries requiring rehabilitative care to support their recovery. This may be more apparent in older Veteran populations. After discharge, Veterans must re-acclimate to their home environment while facing potential changes in their sleep, life engagement (e.g., pleasant activities, physical function), and health. This study will create the I-SLEPT (Integrated Sleep and Life Engagement Program for Transitions) intervention, which will support Veterans by stabilizing their sleep and by maximizing participation in meaningful activities during a critical and vulnerable period of recovery.",[31,423],"Participation",[425,426,427,428,429],"sleep","participation","rehabilitation","transitions of care","physical function",{"date":255,"type":47},{"date":432,"type":47},"2026-06-22",{"date":434,"type":21},"2031-03-31",{"name":436,"class":437},"VA Office of Research and Development","FED",{"id":439,"slug":440,"hasResults":12,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":4,"eligibilityCriteria":444,"healthyVolunteers":88,"sex":17,"minAge":445,"maxAge":4,"enrollmentInfo":446,"targetDuration":4,"studyType":22,"phases":448,"briefSummary":449,"conditions":450,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":452,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":4},"100558313","a-sleep-intervention-for-preschoolers-in-foster-care-100558313","NCT06549491","A Sleep Intervention for Preschoolers in Foster Care","Development and Implementation of a Digital Sleep Intervention for Preschoolers in Foster Care","Inclusion Criteria:\n\n* Participants are only recruited for Aims 2 (Nurturing Sleep pretest) and 3 (RCT of Nurturing Sleep) of the study and must be a US foster parent of a preschool aged child (36 to 71 months) and have a smartphone. Foster parents will be adults 21 years of age or older, per federal requirements for foster parent licensing.\n\nExclusion Criteria:\n\n* Participants will be excluded from the study if they are not English or Spanish speaking, or if the child they are to report on has a serious medical condition or developmental disability that the sleep intervention would not be appropriate for because their medical condition requires more specialized strategies (e.g., cerebral palsy, seizures, autism spectrum disorders). If there is more than one preschool aged child under the foster parent's care, they will implement the intervention and answer study questionnaires based on the child for whom they are most concerned about their sleep.","21 Years",{"count":447,"type":21},72,[24],"Healthy sleep is critical for optimal health and development, but there are no public health interventions to support sleep for children in foster care. This proposal will develop and implement a digital public-health-level intervention to support foster caregivers in promoting healthy sleep in the young children in their care. The digital intervention approach has the potential to maximize scalability and reach to support foster children and their caregivers on a national level.",[31,451],"Foster Care",{"date":200,"type":47},{"date":454,"type":21},"2027-12-01",{"date":456,"type":21},"2030-06-30",{"name":458,"class":54},"Bradley Hospital",{"id":460,"slug":461,"hasResults":12,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":4,"eligibilityCriteria":465,"healthyVolunteers":88,"sex":17,"minAge":466,"maxAge":467,"enrollmentInfo":468,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":470,"conditions":471,"keywords":475,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":481,"startDateStruct":482,"completionDateStruct":4,"leadSponsor":484,"locationsCount":80},"100192257","studying-childhood-onset-behavioral-psychiatric-and-developmental-disorders-100192257","NCT01778504","Studying Childhood-onset Behavioral, Psychiatric, and Developmental Disorders","Diagnosis of Childhood-onset Behavioral Disorders, Neuropsychiatric Disorders and Neurodevelopmental Disorders","* INCLUSION CRITERIA:\n\nParticipants will be eligible if they:\n\n1. Are aged birth to 99 years\n2. Have a diagnosed or undiagnosed neuropsychiatric disorder, neurodevelopmental disability or abnormal behaviors.\n3. Have the ability to understand and sign an informed consent on behalf of themselves or their minor children, or have a legal guardian (or designated DPA).\n4. Are under the care of a primary physician.\n\nEXCLUSION CRITERIA:\n\nParticipants will not be eligible if they:\n\n* Are unwilling or unable to be evaluated and followed as clinically indicated. Examples might include children with severe behavioral problems who refuse physical examination.\n* The participant does not have a primary healthcare provider.","1 Day","99 Years",{"count":469,"type":21},1000,"Background:\n\n\\- Many psychiatric, behavioral, and developmental disorders are genetic. This means that they tend to run in families. Some begin in childhood, while others do not appear until adulthood. Researchers want to look at people of all ages who have these disorders that started in childhood. They will also look at relatives of people with these disorders. This information will allow doctors to learn more about childhood behavioral problems and how they are inherited. It may also help doctors treat those disorders.\n\nObjectives:\n\n\\- To study the onset and treatment of childhood behavioral, psychiatric, and developmental disorders.\n\nEligibility:\n\n* Individuals of any age who have a psychiatric, autism spectrum, or developmental disorder, or other behavioral problems.\n* Family members of individuals with the above disorders. This group may include parents, grandparents, siblings, aunts\u002Funcles, cousins, and children.\n\nDesign:\n\n\\- Participants will be screened with a medical history and physical exam. They may have a psychiatric history with tests of thinking, judgment, and behavior. Brain imaging scans may be performed to look at brain function.",[472,473,474,31],"Neuropsychiatric Disorder","Neurological Disorder","Neurodevelopmental Disorder",[476,477,158,478,479,480],"Natural History Study","Mental Illness","Developmental Delay","Genetic Disorder","Natural History",{"date":296,"type":47},{"date":483,"type":47},"2012-12-27",{"name":485,"class":79},"National Institute of Mental Health (NIMH)",{"id":487,"slug":488,"hasResults":12,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":4,"eligibilityCriteria":492,"healthyVolunteers":12,"sex":17,"minAge":89,"maxAge":493,"enrollmentInfo":494,"targetDuration":4,"studyType":22,"phases":496,"briefSummary":497,"conditions":498,"keywords":500,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":507,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":511,"locationsCount":4},"100626406","robot-assisted-meditation-for-older-adults-with-cognitive-concerns-100626406","NCT07435220","Robot-Assisted Meditation for Older Adults With Cognitive Concerns","Investigating the Effects of Haptic Robot Meditation on Sleep Quality in Older Adults With Cognitive Concerns","Inclusion Criteria:\n\n* Participants have subjective cognitive decline, assessed using the Subjective Cognitive Decline Questionnaire (SCD-Q)\n\nExclusion Criteria:\n\n* Participants do not have dementia or mild cognitive impairment.\n* To exclude significant cognitive impairment, investigators will utilize the Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA).","80 Years",{"count":495,"type":21},100,[24],"While traditional app-based mindfulness meditation programs relying solely on audio guidance have shown potential benefits for older adults, the apps often face challenges such as low compliance. Participants frequently report difficulties in maintaining focus during meditation sessions, which can limit its effectiveness in improving outcomes such as stress reduction and sleep quality. Recognizing these limitations, this study explores whether a haptic-enabled handheld robot can enhance meditation practices by providing both haptic and audio guidance. The robot, designed to foster sustained attention and encourage rhythmic breathing, may offer a novel, multidimensional approach that addresses compliance issues and supports deeper engagement in mindfulness meditation.\n\nThe study primarily seeks to answer the question: Does robot-guided meditation, combining both haptic and audio guidance, improve the sleep quality of older adults living alone with subjective cognitive decline more effectively than traditional audio-based mindfulness meditation guidance? Furthermore, the study examines a secondary question: Is the effect of robot-guided meditation on sleep quality mediated by reductions in stress? By investigating these questions, the research aims to offer insights into whether haptic-enabled meditation technology can overcome common barriers to mindfulness practices among older adults and serve as an innovative tool to improve physical, emotional, and cognitive well-being.",[499,31],"Cognitive Impairment",[501,502,503,504,505,506],"Meditation","Robot","Older adults","Cognitive concerns","Robot-Guided Intervention","Audio-Guided Control",{"date":366,"type":47},{"date":509,"type":21},"2026-11-01",{"date":323,"type":21},{"name":53,"class":54},{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":4,"eligibilityCriteria":518,"healthyVolunteers":88,"sex":17,"minAge":18,"maxAge":89,"enrollmentInfo":519,"targetDuration":4,"studyType":22,"phases":521,"briefSummary":522,"conditions":523,"keywords":525,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":535,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":80},"100579447","sleep-tms-for-depression-100579447","NCT06824415","Sleep TMS for Depression","Optimizing Depression Treatment Through Sleep-state Brain Stimulation","Inclusion Criteria:\n\n* Adults ages 18-65 years\n* Current Major Depressive Disorder (MDD) diagnosis\n* Failed ≥1 antidepressant medication\n* Moderate-to-severe depression\n* Stable antidepressant medication dose for ≥ 6 weeks prior to enrollment\n* Healthy control participants are adults ages 18-65 years without current MDD symptoms, not taking antidepressant or antipsychotic medications, and without major psychiatric, neurological, substance use, medical conditions affecting brain function, or TMS\u002FMRI contraindications.\n\nExclusion Criteria:\n\n* Intellectual disability\n* Significant head injury\u002Fneurological disorder\n* Pregnancy or postpartum\n* TMS\u002FMRI contraindications\n* Active substance use\u002Fsuicidal ideation",{"count":520,"type":21},55,[24],"The goal of this study is to establish the feasibility, tolerability, and preliminary efficacy of sleep-state transcranial magnetic stimulation (TMS) for enhancing plasticity in depression treatment.",[524,31],"Major Depression",[425,526,527,528,529,530,531,532,533],"tms","eeg","iTBS","real-time","closed-loop","NREM","sleep spindle","slow oscillations","2026-06-18",{"date":366,"type":47},{"date":537,"type":47},"2025-05-01",{"date":539,"type":21},"2028-05-30",{"name":541,"class":54},"Stanford University",{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":4,"eligibilityCriteria":548,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":549,"targetDuration":550,"studyType":65,"phases":4,"briefSummary":551,"conditions":552,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":557,"startDateStruct":558,"completionDateStruct":559,"leadSponsor":561,"locationsCount":4},"100644388","objective-sleep-characteristics-and-neoadjuvant-immunotherapy-response-in-gastricgej-cancer-100644388","NCT07662005","Objective Sleep Characteristics and Neoadjuvant Immunotherapy Response in Gastric\u002FGEJ Cancer","Objective Sleep Characteristics and Response to Neoadjuvant Immunotherapy in Locally Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma: A Prospective Observational Study","Inclusion Criteria:\n\n1. Age greater than 18 years, regardless of sex.\n2. Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.\n3. Locally advanced, resectable disease as assessed by imaging or a multidisciplinary team, based on the 8th edition of the AJCC staging system, typically cT3-4a, any N, or any T with N-positive disease, corresponding to stage II-III disease, without distant metastasis.\n4. Scheduled to receive neoadjuvant therapy followed by radical surgery.\n5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1.\n6. No prior systemic anticancer therapy for the current tumor at study baseline.\n7. Willing to participate in the study and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Presence of distant metastasis, peritoneal metastasis, or disease considered no longer suitable for curative-intent treatment.\n2. Prior neoadjuvant chemotherapy, immunotherapy, radiotherapy, or other systemic anticancer therapy for the current tumor.\n3. Severe cognitive impairment, acute psychiatric disorder, or any other condition that prevents the participant from completing study procedures.\n4. Current treatment with antidepressants, anxiolytics, sedative-hypnotics, or other psychotropic medications, with any of the following occurring within 4 weeks before enrollment:\n\n   1. Increase or decrease in the dose of the relevant medication by 25% or more from the previous maintenance dose;\n   2. Initiation, discontinuation, or replacement of antidepressants, anxiolytics, sedative-hypnotics, or other psychotropic medications;\n   3. Adjustment of treatment due to worsening anxiety, depression, insomnia, or other psychiatric or psychological symptoms;\n   4. Any medication change or psychological condition judged by the investigator to potentially affect sleep monitoring results or study compliance.\n5. Any other condition that, in the opinion of the investigator, makes the participant unsuitable for this study.",{"count":91,"type":21},"3 Years","This prospective observational study will enroll 120 patients with locally advanced gastric or gastroesophageal junction adenocarcinoma who are scheduled to receive neoadjuvant immunotherapy followed by radical surgery. Non-invasive objective sleep monitoring will be performed during the neoadjuvant treatment period to assess sleep characteristics, including sleep duration, sleep efficiency, device-estimated deep sleep proportion, nocturnal awakenings, sleep regularity, heart rate, and heart rate variability. The primary objective is to evaluate the association between objective sleep characteristics and major pathological response (MPR) after neoadjuvant immunotherapy. This study will not alter standard treatment decisions, surgical procedures, or perioperative management.",[553,554,31,555],"Gastric Adenocarcinoma","Gastroesophageal Junction Adenocarcinoma","Pathological Response","2026-06-17",{"date":366,"type":47},{"date":255,"type":21},{"date":560,"type":21},"2028-12-31",{"name":562,"class":54},"West China Second University Hospital",{"id":564,"slug":565,"hasResults":12,"nctId":566,"briefTitle":567,"officialTitle":568,"acronym":4,"eligibilityCriteria":569,"healthyVolunteers":88,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":570,"targetDuration":4,"studyType":22,"phases":572,"briefSummary":573,"conditions":574,"keywords":575,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":578,"lastUpdatePostDateStruct":579,"startDateStruct":580,"completionDateStruct":582,"leadSponsor":584,"locationsCount":410},"100473987","a-dyadic-sleep-health-approach-for-persons-with-alzheimers-disease-and-caregivers-100473987","NCT05452031","A Dyadic Sleep Health Approach for Persons With Alzheimer's Disease and Caregivers","A Dyadic Approach to Improve Sleep and Well-Being Among Persons With Alzheimer's Disease and Their Caregivers","Inclusion Criteria for Patients\n\n* Have a diagnosis of Alzheimer's disease (probable or possible) or other related dementia as documented in an electronic medical record\n* Community-dwelling\n* \\>1 sleep problems \\>3x\u002Fweek on the Neuropsychiatric Inventory Nighttime Behavior Scale, - - Aged \\>60 years\n* Have no untreated sleep disorders (e.g., sleep apnea, restless legs syndrome)\n* Able to ambulate with or without assistive devices (i.e., dyads will be excluded if the care recipient is bedbound)\n* Have no severe medical conditions with a life expectancy of less than 6 months\n* Have an eligible caregiver\n\nInclusion Criteria for Caregivers\n\n* Live with an eligible patient\n* Aged \\>18 years\n* Is related to the patient as a family member, a significant other, or a friend\n* Have regularly assisted patient with \\>1 of 6 basic activities of daily living (ADLs; i.e., bathing, dressing, toileting, transferring, continence, feeding) or \\>1 of 8 Instrumental ADL (IADLs; i.e., using the telephone, shopping, food preparation, housekeeping, laundry, transportation, taking medications, managing money) for the past 6 months\n* Pittsburgh Sleep Quality Index (PSQI) total score \\>5\n* Montreal Cognitive Assessment (MoCA) ≥23\n* Can communicate in English\n\nExclusion Criteria:\n\n* Patients will be excluded if they are bedbound or have severe medical conditions with a life expectancy of less than 6 months.\n* Paid, professional caregivers will also be excluded.\n* If the eligibility criteria for either a patient or a caregiver are not met, the dyads will be excluded for this study.",{"count":571,"type":21},672,[24],"This is a randomized controlled trial over 5 years, using Stage II of the NIH-defined stage model for behavioral intervention development. We will evaluate the efficacy of the sleep intervention program (Care2Sleep) on sleep, health status measures, and quality of life (for dyads), and inflammation (for caregivers only). Eligible participants will be randomly assigned to in-person Care2Sleep, telehealth Care2Sleep, or to an in-person education control group. The Care2Sleep programs and the control education program will consist of five sessions. The intervention and control programs will begin after baseline assessment and randomization. Posttreatment assessments will be performed immediately after the last session and at 6-month follow-up.",[31],[576,577],"Dementia","Caregivers","2026-06-16",{"date":534,"type":47},{"date":581,"type":47},"2022-11-09",{"date":583,"type":21},"2027-08-31",{"name":585,"class":54},"University of California, Los Angeles",{"id":587,"slug":588,"hasResults":12,"nctId":589,"briefTitle":590,"officialTitle":591,"acronym":592,"eligibilityCriteria":593,"healthyVolunteers":88,"sex":17,"minAge":216,"maxAge":89,"enrollmentInfo":594,"targetDuration":4,"studyType":22,"phases":596,"briefSummary":597,"conditions":598,"keywords":601,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":604,"lastUpdatePostDateStruct":605,"startDateStruct":607,"completionDateStruct":609,"leadSponsor":610,"locationsCount":80},"100642665","multidimensional-sleep-health-intervention-for-couples-100642665","NCT07603245","Multidimensional Sleep Health Intervention for Couples","DREAM-COUPLES: A Dyadic Multidimensional Sleep Health Intervention","DREAM-COUPLES","Inclusion Criteria:\n\n* Adults aged 30-65 years\n* English-speaking\n* Systolic blood pressure greater than or equal to 120 mmHg (at minimum one individual in dyad)\n* Sub-optimal sleep health (at minimum short\u002Flong sleep duration and\u002For irregular sleep patterns)\n\nExclusion Criteria:\n\n* Optimal sleep health\n* History of cardiovascular disease or cancer\n* Not cognitively able to complete study requirements\n* Known medical conditions that would prevent them from safely participating in the study (severe psychiatric disorders, neurological degenerative disease, substance abuse\u002Fdependence)\n* History of severe depression or high risk of sleep apnea\u002Fuse of a Continuous Positive Airway Pressure (CPAP) device\n* Inability to provide informed consent",{"count":595,"type":21},50,[24],"The goal of this pilot dyadic study is to adapt a multidimensional sleep health (MDSH) intervention, previously disseminated at the individual level, for relationship partners, determine whether it improves sleep health and aspects of cardiometabolic health, and understand the role of dyadic dynamics in intervention effects.\n\nCan a dyadic MDSH intervention improve sleep health and blood pressure (primary outcomes) in relationship partners?\n\nCan a dyadic MDSH intervention improve anthropometric markers of adiposity, psychosocial indicators, stress, dyadic adjustment and coping, self-rated health (secondary outcomes) in relationship partners?\n\nAs this is a single-arm study, there is no control group. All relationship partners will complete a three-tier screening process, attend two in-person visits to receive intervention materials, have blood pressure measured and sleep data collected using in-office and out-of-office monitors, participate in weekly check-in phone calls with research staff over the 8 weeks to support adherence and complete a voluntary follow-up phone call at 16 weeks to provide additional sleep health information. The multidimensional sleep health promotion intervention is based on evidence-based sleep hygiene education and established behavior change techniques and includes: report-back of sleep health profiles, S.M.A.R.T (specific, measurable, attainable, realistic, and timely) goal-setting and establishing a sleep health plan with a fixed sleep schedule, sleep health coaching and dyadic action planning, self-monitoring, virtual sleep hygiene education, motivational feedback, and addressing light and noise in the sleep environment. Mixed methods will be used to understand implementation metrics, processes, and outcomes to establish the successful completion and future expansion of the intervention within this context.",[599,31,600],"Blood Pressure","Cardiovascular Health",[599,31,600,602,603],"Couples","Dyads","2026-06-10",{"date":606,"type":47},"2026-06-12",{"date":608,"type":47},"2026-06-08",{"date":51,"type":21},{"name":611,"class":54},"Columbia University",{"id":613,"slug":614,"hasResults":12,"nctId":615,"briefTitle":616,"officialTitle":617,"acronym":4,"eligibilityCriteria":618,"healthyVolunteers":12,"sex":17,"minAge":619,"maxAge":4,"enrollmentInfo":620,"targetDuration":4,"studyType":22,"phases":621,"briefSummary":622,"conditions":623,"keywords":625,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":629,"lastUpdatePostDateStruct":630,"startDateStruct":631,"completionDateStruct":632,"leadSponsor":634,"locationsCount":636},"100642077","circadian-synchronized-breast-milk-feeding-and-sleep-in-preterm-infants-a-multicenter-randomized-controlled-trial-100642077","NCT07645677","Circadian-Synchronized Breast Milk Feeding and Sleep in Preterm Infants: A Multicenter Randomized Controlled Trial","Effect of Circadian-Synchronized Breast Milk Feeding on Sleep in Preterm Infants: A Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\nPreterm infants born between 28 and 36 weeks of gestation Have reached full enteral feeding Written informed consent signed by a legal guardian\n\nExclusion Criteria:\n\nNeed invasive respiratory support, such as endotracheal intubation Use of sedatives or other medications that may affect the central nervous system or sleep rhythm\n\nPresence of diseases or abnormalities that may affect normal feeding or sleep behavior, including:\n\nCongenital anomalies, such as neurologic or chromosomal abnormalities Congenital gastrointestinal malformations or anorectal malformations Conditions affecting digestion or absorption, such as diarrhea, intestinal obstruction, or necrotizing enterocolitis (NEC) Critical illnesses such as patent ductus arteriosus (PDA), neonatal sepsis, neutropenia, or coagulation disorders","0 Days",{"count":91,"type":21},[24],"This clinical trial aims to find out whether a circadian-synchronized breast milk feeding approach can help improve sleep in preterm infants in the neonatal intensive care unit (NICU).\n\nThe study mainly aims to answer the following questions:\n\nCan this feeding approach improve sleep in preterm infants? Can this feeding approach help preterm infants develop more regular sleep patterns compared with routine breast milk feeding?\n\nResearchers will compare a feeding approach that tries to match the time when breast milk was expressed with the time when the baby is fed, with routine breast milk feeding, to see whether this method can improve sleep in preterm infants.\n\nParticipants will:\n\nBe randomly assigned to 1 of 2 groups: circadian-synchronized breast milk feeding or routine breast milk feeding.\n\nReceive the assigned feeding approach for at least 2 weeks during the study. Have one 12-hour continuous sleep monitoring session at 37 weeks of corrected age.\n\nHave changes in different sleep states recorded and analyzed during the study, so that sleep patterns can be compared between the 2 groups.",[624,31],"Preterm Infant",[626,187,627,628,624,31],"Breast Milk Feeding","Chrononutrition","NICU","2026-06-09",{"date":606,"type":47},{"date":168,"type":21},{"date":633,"type":21},"2027-08-01",{"name":635,"class":54},"Shanghai Jiao Tong University School of Medicine",6,{"id":638,"slug":639,"hasResults":12,"nctId":640,"briefTitle":641,"officialTitle":641,"acronym":642,"eligibilityCriteria":643,"healthyVolunteers":12,"sex":17,"minAge":445,"maxAge":4,"enrollmentInfo":644,"targetDuration":4,"studyType":22,"phases":646,"briefSummary":647,"conditions":648,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":629,"lastUpdatePostDateStruct":650,"startDateStruct":652,"completionDateStruct":653,"leadSponsor":655,"locationsCount":4},"100633488","phase-2-mechanisms-of-cannabidiol-and-sleep-in-the-context-of-alcohol-use-100633488","NCT07527338","Mechanisms of Cannabidiol and Sleep in the Context of Alcohol Use","CALM","Inclusion Criteria:\n\n* Able to provide informed consent\n* Self reported poor sleep quality (PSQI score \\>5)\n* Hazardous or harmful levels of alcohol consumption (MINI AUD score ≧2)\n* No current moderate or severe alcohol withdrawal symptoms (CIWA-Ar)\n* For female participants of childbearing potential: Not pregnant or lactating at the time of study enrollment or trying to become pregnant as confirmed by urine preg. Lack of childbearing potential confirmed by a history of amenorrhea for at least 12 consecutive months and serum FSH level within the laboratory's reference range for postmenopausal females OR documented bilateral oophorectomy and\u002For hysterectomy\n* For female participants of childbearing potential: Agree to use a highly effective contraception method (i.e., a method with a failure rate of less than 1 percent per year when used consistently and correctly) starting at least five days before you begin the study and continuing for full participation.\n* No current use of sleep medications including CBD in the last 90 days\n* No history of complicated alcohol withdrawal (i.e., seizure, delirium tremens, or alcohol hallucinosis).\n* No current or past 6 months active suicidal ideation or suicidal behavior\n* No current diagnosis, or family history of diagnosis, of psychosis; current major psychiatric illness, such as bipolar disorder, major depression, or schizophrenia\n* No current cannabis use disorder (MINI SUD for cannabis score ≧2)\n* History of previous exposure to guaiol through CBD or other cannabis product\n\nExclusion Criteria:\n\n* Current use of anti-epileptic medications (e.g., clobazam, sodium valproate, lamotrigine)\n* Greater than low risk for obstructive sleep apnea (STOP-BANG \\\u003C=4 or Moderate or greater risk as calculated by Nox Noxturnal Software from baseline PSG data)\n* Current use of medications known to have major interactions with Epidiolex (e.g., brexanolone, buprenorphine, colchicine, esketamine, fezolinetant, ketamine, leflunomide, levoketoconazole, levomethadyl acetate, lomitapide, mipomersen, morphine, pexidartinib, pralsetinib, propoxyphene, relugolix, sodium oxybate, teriflunomide, and venetoclax)\n* Current use of anti-psychotic medications\n* Current use of potent CYP2C19 or CYP3A4 inducers (e.g., Rifampin, apalutamide, carbamazepine, enzalutamide, ivosidenib9, lumacaftor, ivacaftor, phenytoin, St. John's wort, Fosphenytoin, Mitotane, Phenobarbital, Primidone)\n* History of hypersensitivity reactions to cannabidiol\n* Liver function test (Alanine transaminase \\[ALT\\] and Aspartate transaminase \\[AST\\]) levels ≥2x the upper normal limits at baseline\n* Moderate or severe liver disease\n* Allergy or aversion to gelatin (softgels contain porcine gelatin)\n* Report of illegal drug use (e.g., cocaine, methamphetamine) in the past 90 days or positive screening on urine toxicology test at Baseline visit.\n* Uncontrolled hypertension\n* Blood pressure findings concerning for moderate or severe alcohol withdrawal at baseline\n* Abnormal resting heart rate, defined as \\\u003C60 bpm or \\>100 bpm at baseline",{"count":645,"type":21},58,[93],"The goal of this clinical trial is to learn if cannabidiol helps to improve sleep and decrease alcohol use. It will also learn about the safety of cannabidiol. The main questions it aims to answer are:\n\nDoes 4 weeks of nightly cannabdiol use:\n\n1. improve sleep quality and time spent in REM sleep?\n2. decrease alcohol use and alcohol craving?\n3. pose any safety risks?\n\nResearchers will compare cannabidiol to a placebo (a look-alike substance that contains no drug).\n\nParticipants will:\n\nTake cannabidiol every night for 4 weeks Visit the clinic once at the beginning and once at the end of the study Wear an activity monitoring watch while in the study Complete an at-home sleep test both at the beginning and the end of the study Check in once a week with researchers via video conference",[31,649],"Alcohol Misuse",{"date":651,"type":47},"2026-06-11",{"date":136,"type":21},{"date":654,"type":21},"2031-04-01",{"name":656,"class":54},"University of Colorado, Boulder"]