[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sleep-wake-disorders\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sleep-wake-disorders":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,48,85,120,150,181,207,232,258,288,313,333],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100644647","multimodal-sleep-promotion-in-surgical-icu-patients-100644647",false,"NCT07672509","Multimodal Sleep Promotion in Surgical ICU Patients","Multimodal Sleep Promotion Intervention in Adult Postoperative Intensive Care Unit Patients: Two-Center Non-Randomized Controlled Pilot Study","MULTISLEEP","Inclusion Criteria:\n\n* Adult patients aged 18 years or older.\n* Patients admitted to an adult intensive care unit after surgery.\n* Expected ICU stay of at least one night.\n* Patients with clinical stability and adequate pain control allowing participation in the intervention and completion of study assessments.\n* Patients able to understand and complete the questionnaires, either independently or with minimal assistance.\n* Patients without language barriers that prevent study participation.\n\nExclusion Criteria:\n\n* Patients with acute neurological impairment or moderate to severe cognitive dysfunction.\n* Patients receiving invasive mechanical ventilation with ongoing sedation.\n* Patients with a severe pre-existing sleep disorder requiring specific treatment not available in the ICU setting.\n* Patients unable to provide questionnaire responses due to communication limitations or clinical condition.\n* Patients with language barriers preventing participation in study procedures and completion of study assessments","ALL","18 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"NA","Sleep disturbances are highly prevalent among patients admitted to intensive care units (ICUs). Critical illness, environmental factors, and routine clinical care frequently result in fragmented sleep, reduced sleep quality, and disruption of normal circadian rhythms. Previous studies have shown that poor sleep in ICU patients may be associated with delirium, impaired recovery, decreased functional outcomes, and lower patient satisfaction.\n\nEnvironmental factors such as noise generated by alarms and medical equipment, continuous light exposure, frequent nursing interventions, pain, anxiety, and discomfort related to invasive devices have been identified as major contributors to sleep disruption in critically ill patients. Several non-pharmacological interventions, including earplugs, eye masks, environmental modifications, and nursing care bundles, have demonstrated potential benefits in improving sleep quality. However, most studies have focused on isolated interventions, and evidence regarding comprehensive multimodal approaches remains limited.\n\nThis two-center non-randomized controlled pilot study aims to evaluate the effectiveness of a multimodal sleep promotion intervention in adult postoperative ICU patients. The intervention combines individualized sleep hygiene education, provision of earplugs and eye masks, environmental measures to reduce nighttime noise and light exposure, and reorganization of nursing care activities to minimize unnecessary sleep interruptions. Patients admitted to the intervention ICU will receive the multimodal sleep promotion program, while patients admitted to the control ICU will receive usual care.\n\nThe primary objective is to assess the effect of the intervention on patient-reported sleep quality. Secondary objectives include evaluating patient experience during ICU stay and exploring the relationship between sleep outcomes and selected demographic and clinical variables. The findings of this pilot study will provide preliminary evidence regarding the feasibility and effectiveness of multimodal sleep promotion strategies in adult ICU settings and may support the development of future larger-scale studies.",[27,28],"Sleep Wake Disorders","Critical Illness",[30,31,32,33,34,35],"Sleep Quality","ICU Patients","Sleep Promotion","Sleep Hygiene","Patient Experience","Humanization of Care","NOT_YET_RECRUITING","2026-06-26",{"date":39,"type":40},"2026-06-29","ACTUAL",{"date":42,"type":21},"2026-07-01",{"date":44,"type":21},"2026-11-30",{"name":46,"class":47},"Fundación de investigación HM","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"100640580","structured-combined-exercise-program-in-postmenopausal-women-effects-on-heart-rate-variability-and-menopausal-symptoms-100640580","NCT07615790","Structured Combined Exercise Program in Postmenopausal Women: Effects on Heart Rate Variability and Menopausal Symptoms","The Effect of a Structured Combined Exercise Program on Heart Rate Variability and Menopausal Symptoms in Postmenopausal Women: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Women in the postmenopausal period\n* Aged between 45 and 65 years\n* Able to communicate and cooperate with the researchers\n* Not participating in another structured exercise program\n* Willing to participate voluntarily in the study\n\nExclusion Criteria:\n\n* Presence of severe cardiovascular, neurological, orthopedic, or psychiatric disease\n* Hormone replacement therapy use during the study period\n* Cognitive impairment affecting participation\n* Uncontrolled hypertension or other unstable medical conditions\n* Regular participation in structured exercise training within the last 6 months\n* Smoking or alcohol use that may affect heart rate variability measurements","FEMALE","45 Years","65 Years",{"count":59,"type":21},40,[24],"The goal of this clinical trial is to learn whether a structured combined exercise program can improve heart health, menopausal symptoms, sleep quality, and quality of life in postmenopausal women aged 45 to 65 years.\n\nThe main questions it aims to answer are:\n\nDoes the exercise program improve heart rate variability, which shows how well the heart is controlled by the nervous system? Does the exercise program lower menopausal symptoms? Does the exercise program improve sleep quality and quality of life?\n\nResearchers will compare women who join the exercise program with women who continue their usual daily activities.\n\nParticipants in the exercise group will take part in a supervised exercise program for 12 weeks. They will exercise 2 days each week. Each session will last 45 minutes and will include warm-up, balance, strengthening, coordination, flexibility, and cool-down exercises.\n\nParticipants in the control group will continue their usual daily activities during the study.",[63,64,65,27],"Postmenopausal","Menopausal Symptoms","Autonomic Nervous System Diseases",[67,68,69,70,71,72,73],"Structured combined exercise","Postmenopausal women","Heart rate variability","Cardiac autonomic function","Menopausal symptoms","Sleep quality","Quality of life","RECRUITING","2026-05-28",{"date":77,"type":40},"2026-05-29",{"date":79,"type":40},"2026-04-27",{"date":81,"type":21},"2026-09",{"name":83,"class":47},"Fenerbahce University",1,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":93,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":96,"briefSummary":97,"conditions":98,"keywords":102,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":84},"100626690","mind-after-midnight-100626690","NCT07438912","Mind After Midnight","The Mind After Midnight: Mechanistic Examination of Nocturnal Wakefulness as a Suicide Risk Factor","MaM","Inclusion Criteria\n\n* Age 18-55 years\n* History of suicidal ideation within the past 6 months\n* Habitual bedtime between 9:00 PM and 1:00 AM\n* Habitual wake time between 6:00 AM and 9:00 AM\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Current suicidal intent requiring immediate clinical intervention\n* Diagnosis of a primary sleep disorder (e.g., untreated obstructive sleep apnea, narcolepsy)\n* Bipolar disorder or psychotic disorder\n* Substance use disorder within the past 3 months\n* Use of medications that significantly affect sleep or circadian rhythms\n* Night shift work or transmeridian travel within the past month\n* Medical or neurological condition that would interfere with participation\n* Pregnancy","55 Years",{"count":95,"type":21},90,[24],"This study examines whether wakefulness during the biological night (2:00-4:00 AM) is associated with increased negative mood, impaired decision-making, and suicidal thoughts. Adults with a history of suicidal ideation in the past six months will complete laboratory and home-based assessments under varying levels of sleep pressure. Participants will be evaluated during late-night wakefulness and under conditions of both higher and lower sleep pressure. The goal of the study is to better understand the biological and behavioral mechanisms that may contribute to elevated suicide risk during nocturnal wakefulness.",[99,100,101,27],"Suicidal Ideation","Circadian Rhythm Disorders","Sleep Deprivation",[103,104,105,106,107,108,109,110],"Nocturnal Wakefulness","Suicide Risk","Circadian Misalignment","Impulsivity","Mood Regulation","Biological Night","Sleep Pressure","Decision-Making","2026-05-19",{"date":113,"type":40},"2026-05-22",{"date":115,"type":40},"2026-03-06",{"date":117,"type":21},"2029-08-31",{"name":119,"class":47},"University of Arizona",{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":127,"sex":17,"minAge":128,"maxAge":57,"enrollmentInfo":129,"targetDuration":4,"studyType":22,"phases":131,"briefSummary":132,"conditions":133,"keywords":134,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":84},"100631287","effect-of-l-reuteri-lm1063-on-sleep-health-improvement-100631287","NCT07498712","Effect of L. Reuteri LM1063 on Sleep Health Improvement","Effect and Safety of Limosilactobacillus Reuteri LM1063 Supplementation on the Improvement of Sleep Health: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial","Inclusion Criteria:\n\n* Healthy male or female adults aged 19 to 65.\n* Pittsburgh Sleep Quality Index (PSQI) score of 5 or higher.\n* Voluntarily agreed to participate and signed the informed consent form.\n\nExclusion Criteria:\n\n* Severe sleep disorders (Insomnia Severity Index ≥ 22 or ≤ 7).\n* Medical conditions causing sleep disorders (Sleep apnea, Restless legs syndrome, Depression, Narcolepsy, etc.).\n* Intake of medications affecting sleep within 1 month before the first visit.\n* Intake of probiotics or fermented milk products within 1 month before the first visit.",true,"19 Years",{"count":130,"type":21},80,[24],"Purpose:\n\nThe purpose of this clinical trial is to evaluate the efficacy and safety of Limosilactobacillus reuteri LM1063 on improving sleep health in healthy adults. Based on the microbiota-gut-brain axis, this study aims to scientifically analyze whether the supplementation of this specific probiotic strain can enhance sleep quality.\n\nMethodology:\n\nThis is a randomized, double-blind, placebo-controlled, single-center clinical trial. A total of 80 participants (40 in the test group and 40 in the control group) will be enrolled. Participants in the test group will consume 500 mg of L. reuteri LM1063 (1.0 x 10\\^10 CFU\u002Fday) once daily for 8 weeks, while the control group will receive a placebo.\n\nKey Evaluations:\n\nTo assess sleep improvement, various parameters will be measured before and after the 8-week intake period:\n\n* Primary Outcomes: Polysomnography (PSG) measures including sleep efficiency (SE), sleep latency (SL), total sleep time (TST), wake after sleep onset (WASO), and delta power; and the Pittsburgh Sleep Quality Index (PSQI).\n* Secondary Outcomes: Various sleep and stress-related scales (SSS, ESS, PSS, RSQ-W, FSS) and blood biomarkers such as melatonin, GABA, and serotonin levels.\n* Safety: Monitored through adverse events, vital signs, and clinical laboratory tests.",[30,27],[135,136,137,138,139],"probiotics","Limosilactobacillus reuteri","sleep health","L. reuteri LM1063","gut-brain axis","2026-03-23",{"date":142,"type":40},"2026-03-27",{"date":144,"type":40},"2025-07-14",{"date":146,"type":21},"2026-06-30",{"name":148,"class":149},"Lactomason Co., Ltd.","INDUSTRY",{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":127,"sex":17,"minAge":158,"maxAge":57,"enrollmentInfo":159,"targetDuration":4,"studyType":161,"phases":4,"briefSummary":162,"conditions":163,"keywords":167,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":4},"100627166","physical-activity-levels-and-musculoskeletal-health-among-health-science-academicians-at-istanbul-aydin-university-100627166","NCT07445100","Physical Activity Levels and Musculoskeletal Health Among Health Science Academicians at Istanbul Aydin University","PHYSICAL ACTIVITY LEVELS AND THEIR ASSOCIATION WITH POSTURE, SLEEP QUALITY, DEPRESSION, AND MUSCULOSKELETAL PROBLEMS AMONG HEALTH SCIENCE ACADEMICIANS AT ISTANBUL AYDIN UNIVERSITY","PA-ACAD-IAU","Inclusion Criteria:\n\n* Academicians working in the Faculty of Health Sciences at Istanbul Aydın University\n* Aged between 23 and 65 years\n* At least 1 year of academic experience\n* Voluntary agreement to participate and signed informed consent\n\nExclusion Criteria:\n\n* Diagnosis of severe psychiatric disorders (e.g., schizophrenia)\n* Pregnancy\n* Use of antipsychotic medication\n* History of recent trauma or surgical operation within the last year\n* Severe musculoskeletal disorders requiring medical or surgical treatment (e.g., advanced scoliosis or kyphosis)","23 Years",{"count":160,"type":21},73,"OBSERVATIONAL","This study aims to investigate the relationship between physical activity levels and posture, sleep quality, depression, and musculoskeletal system problems among academic staff working in the health sciences field at Istanbul Aydın University.\n\nModern technological developments and sedentary work patterns have significantly reduced daily physical activity levels. Academic personnel often spend long hours sitting, preparing lectures, conducting research, and using computers, which may negatively affect posture and increase the risk of musculoskeletal pain. Reduced physical activity has also been associated with poor sleep quality and increased depressive symptoms.\n\nThis cross-sectional study will include academic staff aged 23-65 years working in the Faculty of Health Sciences. Participation will be voluntary. Data will be collected using a sociodemographic information form and validated assessment tools, including the International Physical Activity Questionnaire-Short Form (IPAQ), New York Posture Rating Chart, Pittsburgh Sleep Quality Index (PSQI), Beck Depression Inventory (BDI), and the Nordic Musculoskeletal Questionnaire.\n\nThe primary objective is to evaluate whether physical activity levels are associated with posture, sleep quality, depression levels, and musculoskeletal complaints. The findings are expected to contribute to the development of preventive strategies aimed at improving occupational health, well-being, and quality of life among academic personnel.",[164,165,27,166],"Musculoskeletal Diseases","Depression","Posture",[168,169,170,30,171],"Academic Personnel","Occupational Health","Musculoskeletal Pain","Cross-Sectional Study","2026-02-25",{"date":174,"type":40},"2026-03-03",{"date":176,"type":21},"2026-03",{"date":178,"type":21},"2026-05",{"name":180,"class":47},"Istanbul Aydın University",{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":127,"sex":188,"minAge":56,"maxAge":189,"enrollmentInfo":190,"targetDuration":4,"studyType":22,"phases":191,"briefSummary":192,"conditions":193,"keywords":196,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":4},"100623858","effect-of-a-mindfulness-based-stress-reduction-program-on-hot-flashes-and-sleep-quality-in-menopausal-women-a-randomized-controlled-trial-100623858","NCT07402096","Effect of a Mindfulness-Based Stress Reduction Program on Hot Flashes and Sleep Quality in Menopausal Women: A Randomized Controlled Trial","MBSR-MENO","Inclusion Criteria:\n\n* \\- Women aged between 45 and 60 years\n* Postmenopausal status defined as at least 12 months since the last menstrual period\n* Presence of hot flashes\n* Poor sleep quality (Pittsburgh Sleep Quality Index score \\>5)\n* Ability to understand and complete questionnaires\n* Access to the internet and ability to use a smartphone or computer for online sessions\n* Willingness to participate and provide written informed consent\n\nExclusion Criteria:\n\n* Current use of hormone replacement therapy\n\n  * Use of psychiatric medications\n  * Diagnosis of a psychiatric disorder\n  * Severe hearing or visual impairment\n  * Previous participation in mindfulness-based or yoga programs\n  * Incomplete baseline assessments\n  * Failure to attend intervention sessions","MALE","60 Years",{"count":95,"type":21},[24],"Menopause is a natural transition characterized by vasomotor symptoms such as hot flashes and sleep disturbances, which can significantly impair quality of life. Non-pharmacological interventions are increasingly recommended for women who cannot or prefer not to use hormone therapy. Mindfulness-Based Stress Reduction (MBSR) is a structured behavioral intervention that has shown beneficial effects on stress-related symptoms and sleep quality; however, evidence regarding its effects on menopausal symptoms remains limited.\n\nThis randomized controlled trial aims to evaluate the effectiveness of an 8-week MBSR program on hot flash frequency and severity and sleep quality in menopausal women. A total of 90 menopausal women will be randomly assigned to either an intervention group receiving the MBSR program or a control group receiving no intervention. Participants in the intervention group will attend weekly sessions and engage in mindfulness practices, including breathing awareness, body scan, and stress management techniques.\n\nPrimary outcomes include changes in hot flash frequency and severity and sleep quality, assessed using validated self-report measures. The findings of this study are expected to contribute to evidence-based, non-pharmacological management strategies for menopausal symptoms.",[194,195,27],"Menopause","Hot Flashes",[194,195,197],"Non-pharmacological intervention","2026-02-03",{"date":200,"type":40},"2026-02-11",{"date":202,"type":21},"2026-05-15",{"date":204,"type":21},"2026-12",{"name":206,"class":47},"Inonu University",{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":22,"phases":216,"briefSummary":217,"conditions":218,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":84},"100614998","enhanced-ward-rounds-and-communication-for-pre-procedural-anxiety-in-gi-endoscopy-patients-100614998","NCT07286877","Enhanced Ward Rounds and Communication for Pre-procedural Anxiety in GI Endoscopy Patients","Enhanced Ward-Round Frequency With Standardized Communication for Pre-procedural Anxiety in Hospitalized Patients Undergoing Therapeutic Gastrointestinal Endoscopy","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Inpatients scheduled for therapeutic gastrointestinal endoscopy (e.g., ESD\u002FEMR, therapeutic colonoscopy).\n3. Able to provide informed consent and complete required assessments.\n\nExclusion Criteria:\n\nEmergency\u002Fimmediate endoscopy required.\n\n1. Severe cognitive impairment or psychotic disorder affecting assessments. Isolation\u002Fsingle room preventing protocol implementation.\n2. Unable to complete the primary pre-procedure assessment within the 2-4 hour window.",{"count":215,"type":21},1000,[24],"This study tests a new way to help reduce anxiety in hospitalized patients waiting for therapeutic gastrointestinal (GI) endoscopy procedures, like EMR or ESD. Anxiety before these procedures is common and can make preparation harder, increase medication needs, and affect recovery.\n\nWe compare standard ward checks (twice a day) to enhanced checks (four times a day) with structured talks and simple relaxation exercises. The goal is to see if the enhanced approach lowers anxiety levels, measured by a standard scale called the Hamilton Anxiety Rating Scale (HAM-A), from baseline to 24 hours before the procedure.\n\nWho can join? Adults (18+) scheduled for inpatient GI endoscopy with at least 2 days hospital stay and mild anxiety. Exclusions include emergencies or severe mental health issues.\n\nThe study is done in hospital wards, with groups assigned by ward periods to keep it real-world. Benefits may include less anxiety and better experience; risks are low as it's just more supportive talks. Participation is voluntary with informed consent. Results could improve hospital care routines.",[219,220,27,221,222],"Anxiety","Depression Disorders","Gastrointestinal Diseases","Preoperative Anxiety","2025-12-13",{"date":225,"type":40},"2025-12-16",{"date":227,"type":21},"2026-01-15",{"date":229,"type":21},"2027-02-20",{"name":231,"class":47},"LanZhou University",{"id":233,"slug":234,"hasResults":11,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":239,"enrollmentInfo":240,"targetDuration":4,"studyType":22,"phases":242,"briefSummary":244,"conditions":245,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":257},"100412617","phase-3-evaluating-the-effects-of-tasimelteon-vs-placebo-in-delayed-sleep-wake-phase-disorder-dswpd-100412617","NCT04652882","Evaluating the Effects of Tasimelteon vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD)","A Multicenter, Double-blind, Randomized Study to Evaluate the Effects of Tasimelteon vs. Placebo in Participants With Delayed Sleep-Wake Phase Disorder (DSWPD)","Inclusion Criteria:\n\n* Ability and acceptance to provide written informed consent.\n* A confirmed clinical diagnosis of Delayed Sleep-Wake Phase Disorder (DSWPD).\n* Men or women between 18 - 75 years, inclusive.\n* Body Mass Index (BMI) of ≥ 18 and ≤ 35 kg\u002Fm\\^2.\n\nExclusion Criteria:\n\n* Exacerbation of an existing psychiatric condition that requires change in treatment or intervention in the past 3 months.\n* Major surgery, trauma, illness, general anesthesia, or immobility for 3 or more days within the last 30 days.\n* Pregnancy, recent pregnancy (within 6 weeks), or women who are breastfeeding.\n* A positive test for substances of abuse.\n* Current tobacco user.","75 Years",{"count":241,"type":21},70,[243],"PHASE3","This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female participants with DSWPD.",[27,246,247],"Sleep Disorders, Circadian Rhythm","Chronobiology Disorders","2025-11-24",{"date":250,"type":40},"2025-12-02",{"date":252,"type":40},"2020-12-09",{"date":254,"type":21},"2026-06",{"name":256,"class":149},"Vanda Pharmaceuticals",17,{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":127,"sex":17,"minAge":18,"maxAge":266,"enrollmentInfo":267,"targetDuration":269,"studyType":161,"phases":4,"briefSummary":270,"conditions":271,"keywords":275,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":84},"100603957","sleep-disorders-in-hypothalamic-and-pituitary-damage-100603957","NCT07143266","Sleep Disorders in Hypothalamic and Pituitary Damage","Multidisciplinary Approach to Elucidate the Pathophysiology of Sleep Disorders in Patients With Hypothalamic and Pituitary Damage","SDHPD","Inclusion Criteria:\n\n* Patients with hypothalamic-pituitary dysfunction (HPD) with at least one pituitary hormone deficiency and at least one clinical sign of hypothalamic damage (e.g., arginine-vasopressin deficiency (AVP-D) and\u002For severe obesity and\u002For hyperphagia; MRI suggestive of hypothalamic damage; traumatic brain injury; radiotherapy in the sellar region and\u002For brain tumors affecting the hypothalamus).\n* Healthy controls matched for BMI, age, and sex.\n\nExclusion Criteria:\n\n* Poor control of hormonal deficiencies in the previous 6 months.\n* Use of new psychoactive drugs in the last 3 months or occasional use.\n* Clinically significant liver, lung, kidney, and cardiovascular disease.\n* Any neurological condition affecting brain function (stroke, dementia, uncontrolled epilepsy with recent seizures).\n* Uncontrolled diabetes mellitus.\n* Active psychosis.\n* Ophthalmology: total blindness, Glaucoma, uveitis, visual acuity \\\u003C0.6, or eye surgery in the previous 6 months.\n* Any acute illness that the investigator determines may interfere with study participation or safety.\n* Pregnancy or breastfeeding.\n* Patients who refuse or are unable to provide written informed consent.\n* In controls: presence of brain or pituitary tumor, radiation involving the hypothalamus or pituitary, and history of hypopituitarism.","70 Years",{"count":268,"type":21},60,"3 Months","Hypothalamus has a key role in multiple vital functions, including regulation of sleep-wake cycles. Oxytocin (OT), a neurohormone synthetized in the hypothalamus, has a wide range of physiological functions, including a putative role in improving sleep quality. Hypothalamic and pituitary damage (HPD) is associated with a clinically relevant OT deficient state and multiple and severe comorbidities including poor sleep quality, that have a well-known negative impact on general health and quality of life (QoL). Several factors may coexist in the pathophysiology of sleep disorders (SD) in HPD and SD might be a keystone in the persistence of some of the comorbidities observed in HPD. Therefore, appropriate identification and understanding of the mechanisms contributing to SD in HPD is mandatory to choose adequate preventive strategies and treatment. This project is aimed to (1) identify the prevalence of SD in HPD, (2) to determine OT role in sleep quality and (3) to identify potential mechanisms and mediators of sleep quality and their associations with clinical outcomes in patients with HPD with the ultimate goal of identifying preventive and therapeutic targets. We will use a controlled cross-sectional design of patients with HPD and sex-, BMI-, age- matched controls and an innovative cross-disciplinary approach bridging neuroendocrinology, psychology, neurophysiology, neuroimaging, nuclear medicine and neuroophthalmology disciplines to learn about the prevalence of SD in HPD and to disentangle the underpinning mechanisms behind SDs in HPD. The results of this project will be an extremely important step towards optimizing therapy for patients with HPD who have higher mortality and poor QoL despite appropriate hormone replacement therapy.",[272,27,273,274],"Hypopituitarism","Hypothalamic Diseases","Oxytocin Deficiency",[276,277,272,278],"Sleep Disorder","Oxytocin deficiency","Hypothalamic damage","2025-11-14",{"date":281,"type":40},"2025-11-18",{"date":283,"type":40},"2025-09-01",{"date":285,"type":21},"2027-12",{"name":287,"class":47},"Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau",{"id":289,"slug":290,"hasResults":11,"nctId":291,"briefTitle":292,"officialTitle":292,"acronym":4,"eligibilityCriteria":293,"healthyVolunteers":11,"sex":17,"minAge":294,"maxAge":239,"enrollmentInfo":295,"targetDuration":4,"studyType":22,"phases":297,"briefSummary":299,"conditions":300,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":312},"100575940","phase-4-clinical-study-of-perioperative-sleep-disorders-in-cardiac-surgery-100575940","NCT06778811","Clinical Study of Perioperative Sleep Disorders in Cardiac Surgery","Inclusion Criteria:\n\n1. ASA class II-III, NYHA class I-III, EF ≥ 50%\n2. Intended to perform cardiac surgery under extracorporeal circulation\n\nExclusion Criteria:\n\n1. Patients undergoing second heart surgery\n2. Patients with mental retardation, deafness, or other conditions that interfere with normal communication\n3. Previous neurological or psychiatric disorders\n4. Patients with a history of sleep disorders\n5. Alcoholics, drug addicts, or psychotropic substance abusers\n6. Significant hepatic or renal dysfunction affecting drug metabolism\n7. Contraindication to the use of dexmedetomidine or esketamine.","40 Years",{"count":296,"type":21},180,[298],"PHASE4","The aim of this clinical trial is to understand the effects of dexmedetomidine and esketamine on postoperative sleep in patients undergoing cardiac surgery. The main questions it aims to answer are:\n\nDoes dexmedetomidine or esketamine prevent the development of postoperative sleep disturbances? Which one works better? The researchers compared dexmedetomidine and esketamine with saline (a drug-free solvent) to see if dexmedetomidine and esketamine prevented the development of postoperative sleep disturbances.\n\nParticipants will:\n\n1. Intraoperative continuous infusion of dexmedetomidine, esketamine or saline until the end of surgery\n2. Postoperative sleep was assessed on the first and third postoperative days using a sleep rating scale",[27,301,302],"Esketamine and the Quality of Recovery","Dexmedetomidine","2025-02-05",{"date":305,"type":40},"2025-02-07",{"date":307,"type":40},"2024-10-11",{"date":309,"type":21},"2025-09",{"name":311,"class":47},"Nanjing First Hospital, Nanjing Medical University",2,{"id":314,"slug":315,"hasResults":11,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":4,"eligibilityCriteria":319,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":239,"enrollmentInfo":320,"targetDuration":4,"studyType":22,"phases":321,"briefSummary":322,"conditions":323,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":84},"100569988","phase-3-evaluating-the-effects-of-tasimelteon-vs-placebo-in-delayed-sleep-wake-phase-disorder-dswpd-and-the-cry111-variant-100569988","NCT06701396","Evaluating the Effects of Tasimelteon Vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant","A Double-Blind, Randomized, Two-Period Crossover Study to Evaluate the Effects of Tasimelteon Vs. Placebo in Subjects with Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant","Inclusion Criteria:\n\n* Ability and acceptance to provide written informed consent.\n* A confirmed clinical diagnosis of Delayed Sleep-Wake Phase Disorder (DSWPD).\n* Carrier of CRY1Δ11 variant.\n* Men or women between 18 - 75 years, inclusive.\n* Body Mass Index (BMI) of ≥ 18 and ≤ 40 kg\u002Fm\\^2.\n\nExclusion Criteria:\n\n* Major surgery, trauma, illness, general anesthesia, or immobility for 3 or more days within the last 30 days.\n* Pregnancy, recent pregnancy (within 6 weeks), or women who are breastfeeding.\n* A positive test for substances of abuse.\n* Current tobacco user.",{"count":268,"type":21},[243],"This is a double-blind, randomized, two-period crossover study to evaluate the efficacy and safety of a single oral dose of tasimelteon and matching placebo in male and female subjects with DSWPD and the CRY1Δ11 variant.",[27,246,247,324],"Gene Mutations and Other Alterations Nec","2024-11-19",{"date":327,"type":40},"2024-11-22",{"date":329,"type":40},"2024-10-08",{"date":331,"type":21},"2025-06-30",{"name":256,"class":149},{"id":334,"slug":335,"hasResults":11,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":4,"eligibilityCriteria":339,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":22,"phases":342,"briefSummary":344,"conditions":345,"keywords":354,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":84},"100482730","phase-2-sleep-healthy-using-the-internet-mitigating-insomnia-to-address-neurocognitive-difficulties-shuti-mind-100482730","NCT05565833","Sleep Healthy Using the Internet Mitigating Insomnia to Address Neurocognitive Difficulties (SHUTi MIND)","Internet-based Insomnia Intervention to Prevent Cognitive Decline in Older Adults With Mild Cognitive Impairment (SHUTi MIND)","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, aged ≥ 65 years of age.\n* Able to speak and read English, and is a US resident.\n* Have access to any Internet-enabled device (computer, tablet, smartphone) and willing to be emailed about the study.\n* Sleep-onset insomnia and\u002For sleep maintenance insomnia symptoms\n* The sleep disturbance (or associated daytime fatigue) causes significant distress or impairment in social, occupational, or other areas of functioning over the past three months.\n* Cognitive impairment through study assessment.\n* Stable medication regimen unless medication is known to cause insomnia\n\nExclusion Criteria:\n\n* Current psychological treatment for insomnia\n* Initiation of psychological or psychiatric treatment within the past three months\n* Current diagnosis of Huntington's or Parkinson's disease\n* Current treatment for hyperthyroidism\n* Currently undergoing chemotherapy\n* Presence of asthma or respiratory concerns with night treatment\n* Chronic pain treated with opioids\n* Not recovered from a brain tumor, injury, or infection\n* Epilepsy without stable treatment for at least 3 months\n* Irregular sleep schedule\n* Use of stimulating medications after 5pm or taken for less than 3 months\n* Psychotic or bipolar disorder\n* Moderate to high risk of suicide\n* Alcohol or drug abuse within the past year\n* Other untreated sleep disorders (e.g., obstructive sleep apnea)\n* Study screen for severe depression",{"count":341,"type":21},144,[343],"PHASE2","This randomized controlled trial will evaluate the impact of an Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) intervention on sleep and the extent to which it contributes to cognitive health in individuals with mild cognitive impairment. Participants with insomnia who meet the study criteria for mild cognitive impairment will be recruited to determine the effects of the CBT-I intervention compared to a patient education condition on sleep and cognition. Internet-based recruitment methods will be used, and outcomes include sleep variables, daytime variables, and cognitive status.",[346,347,348,349,350,351,27,352,353],"Insomnia","Cognitive Dysfunction","Mild Cognitive Impairment","Sleep Initiation and Maintenance Disorders","Sleep Disorders, Intrinsic","Dyssomnias","Nervous System Diseases","Alzheimer Disease",[346,355,356,357],"Alzheimer's disease","Mild cognitive impairment","Cognitive behavioral therapy","2024-05-06",{"date":360,"type":40},"2024-05-08",{"date":362,"type":40},"2023-02-27",{"date":364,"type":21},"2028-01",{"name":366,"class":47},"University of Virginia"]