[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"insomnia-primary\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:insomnia-primary":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,39,70,102],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100623289","efficiency-of-intermittent-hypoxia-intervention-in-primary-insomnia-100623289",false,"NCT07394699","Efficiency of Intermittent Hypoxia Intervention in Primary Insomnia","Inclusion Criteria:\n\n* Subjects are diagnosed with primary insomnia between 18 and 60 years old，gender is not limited.\n* Patients who are not taking sedative-hypnotic drugs or have stopped taking drugs for more than 2 weeks.\n* Residing in the plains all year round and not having been above 1500 meters above sea level in the past 30 days.\n* Quiet state SaO2 ≥ 90%, cerebral oxygen saturation 58-82%, heart rate 60-100 beats\u002Fmin, blood pressure 90-140\u002F60-90 mmHg, respiratory rate 16-20 times\u002Fmin.\n* No functional drinks, caffeine-containing beverages, or sleep-disturbing medications during the study period.\n\nExclusion Criteria:\n\n* Stroke onset in the past 3 months, other severe neurological diseases, such as epilepsy, intracranial infectious diseases or demyelination.\n* Uncontrolled hypertension (systolic blood pressure ≥200mmHg) with antihypertensive drugs before enrollment, other cardiovascular diseases.\n* History of pulmonary, hepatic, dermatologic, or hematologic diseases.\n* History of substance abuse.\n* Pregnancy, Severe sleep apnea and neurological disorders.","ALL","18 Years","60 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of this study was to understand the effectiveness of intermittent hypoxia in the treatment of primary insomnia.",[26],"Insomnia, Primary","NOT_YET_RECRUITING","2026-02-05",{"date":30,"type":31},"2026-02-06","ACTUAL",{"date":33,"type":20},"2026-04-01",{"date":35,"type":20},"2028-12-31",{"name":37,"class":38},"Capital Medical University","OTHER",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":21,"phases":48,"briefSummary":50,"conditions":51,"keywords":56,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":5},"100537740","early-phase-1-cognitive-behavioral-therapy-and-trazodone-effects-on-sleep-and-blood-pressure-in-insomnia-100537740","NCT06281756","Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia","Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia Phenotypes Based on Objective Sleep Duration: A Sequential Cohort\u002FRandomized Controlled Trial","Inclusion Criteria:\n\n* Age 18 or older\n* Able to read and effectively communicate in English at the United States sites or able to read and effectively communicate in English or French at the Canadian site.\n* Meets criteria for chronic insomnia\n* Body Mass Index (BMI) 18.5 kg\u002Fm2 and higher\n\nExclusion Criteria:\n\n* Age \\\u003C 18\n* Unable to read and effectively communicate in English at the United States sites or able to read and effectively communicate in English or French at the Canadian site.\n* Unwilling to share email address\u002Fcell phone number to accept survey links.\n* Life time diagnosis of psychotic or bipolar disorder\n* History of severe apnea or an Apnea Hypopnea Index (AHI) ≥15 that is not currently treated with Positive Airway Pressure (PAP) therapy, an oral device or an implanted device, or was not treated with surgery or weight loss.\n* Started new or changed treatment for sleep apnea in the past three months\n* Does not meet criteria for chronic insomnia\n* Meets criteria for narcolepsy or hypersomnia disorder\n* Meets criteria for circadian rhythm disorder (including night shift work)\n* Unstable medical conditions that would make participation unsafe or unfeasible\n* Falls resulting in hospitalization, significant injury or fracture within past 12 months\n* 2 hospitalizations or emergency room visits within past 12 months for chronic conditions\n* Active chemotherapy or radiation therapy for cancer\n* Lifetime diagnoses\u002Ftreatment of chronic renal failure, hepatic insufficiency, chronic heart failure\n* Does not agree to refrain from other treatments for insomnia beyond what is offered in this study\n* BMI less than 18.5\n* Substance abuse or dependence in the past 12 months\n* Current use of prescription or over the counter medications taken for sleep greater than 2 times per week\n* Current use of systemic corticosteroids or opiate medications\n* Current pregnancy or breastfeeding; plans to get pregnant or unwillingness to use birth control for the length of the study\n* Current use of medications contraindicated with trazodone\n* Sleep apnea or periodic leg movement disorder as determined by sleep study\n* Blood Pressure levels defined as seated SBP greater than 180 or DBP greater than 110 mmHg\n* EKG corrected QT interval greater than or equal to 500 ms",{"count":47,"type":20},600,[49],"EARLY_PHASE1","Individuals who have insomnia with short sleep duration (ISS) differ from individuals who have insomnia with normal sleep duration (INS) in terms of health risks (i.e., hypertension) and treatment response. This study will examine whether patients with ISS and INS demonstrate a differential response to two common insomnia treatments. One is behavioral, Cognitive Behavioral Therapy for Insomnia (CBT-I). The other is a widely prescribed, non-habit-forming medication, trazodone used at a low dose. The investigators' findings could lead to evidence-based treatment guidelines that help clinicians more effectively match treatments to insomnia patients and reduce associated health problems.",[52,53,26,54,55],"Insomnia","Insomnia Chronic","Blood Pressure","Blood Pressure, High",[57,58,59],"sleep","sleep disorder","insomnia","RECRUITING","2025-11-06",{"date":63,"type":31},"2025-11-10",{"date":65,"type":31},"2024-03-20",{"date":67,"type":20},"2028-05-31",{"name":69,"class":38},"Milton S. Hershey Medical Center",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":88,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100575042","comparative-efficacy-of-brt-and-cbt-i-for-insomnia-100575042","NCT06767137","Comparative Efficacy of BRT and CBT-I for Insomnia","Comparative Efficacy of Bedtime Restriction Therapy and Cognitive Behavioral Therapy for Insomnia - a Randomized Controlled Non-inferiority Trial","SLEEPwindow","Inclusion Criteria:\n\n* Must meet DSM-5 criteria for insomnia disorder.\n* Adults aged 18 to 80 years\n* Capable of giving written informed consent.\n* Sufficient fluency in the study site's language (i.e., German or French) to understand all study-related information.\n\nExclusion Criteria:\n\n* Unstable, progressive, or degenerative medical condition\n* Acute pain or poorly managed chronic pain\n* Suicidality\n* Uncontrolled psychiatric condition requiring treatment outside of study\n* Alcohol or drug abuse or dependency\n* Diagnosis of psychosis, bipolar disorder, autism, borderline personality disorder, or antisocial personality disorder\n* Clinical evidence of sleep disorders other than insomnia (e.g., sleep apnea, restless legs, periodic limb movements in sleep, parasomnia)\n* Evidence of intellectual disability\n* Regular intake of benzodiazepines (BZD) or benzodiazepine receptor agonists (BZDRA)\n* Alteration of medication within 4 weeks prior to study treatment or planned alteration during the trial period (stable medication except BZD or BZDRA does not lead to exclusion)\n* Current other psychotherapy for insomnia\n* Known pregnancy or breastfeeding\n* Inability to comply with study procedure\n* Insufficient fluency in German or French to complete the study","80 Years",{"count":80,"type":20},160,[23],"This study evaluates two behavioral treatments for patients with insomnia disorder: Bedtime Restriction Therapy (BRT) and Cognitive Behavioral Therapy for Insomnia (CBT-I). Both therapies aim to improve the clinical symptomatology of insomnia by teaching participants techniques to better manage their sleep schedule and habits. BRT is a simpler and shorter therapy focused on aligning the time spent in bed with reported sleep time. CBT-I includes additional components such as relaxation techniques and cognitive exercises. The study will compare these treatments to see if BRT is as effective as CBT-I in improving the clinical symptomatology of insomnia.",[84,85,52,53,26,86,87],"Insomnia Disorders","Insomnia Disorder","Insomnia, Nonorganic","Insomnia Type; Sleep Disorder",[59,89,90,91],"cognitive behavioral therapy","bedtime restriction","sleep restriction","2025-02-13",{"date":94,"type":31},"2025-02-17",{"date":96,"type":20},"2025-03-10",{"date":98,"type":20},"2027-11-01",{"name":100,"class":38},"Christoph Nissen",2,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":21,"phases":111,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":123},"100435694","transcranial-magnetic-stimulation-of-the-default-mode-network-to-improve-sleep-100435694","NCT04953559","Transcranial Magnetic Stimulation of the Default Mode Network to Improve Sleep","Inclusion Criteria:\n\n* Healthy men and non-pregnant, non-lactating women 18-50 (inclusive) years of age, free from contraindicated diseases, medications, devices, and conditions.\n* Participants must meet the criteria for primary insomnia as determined by scores on the ISI, PSQI, and ESS. Participants must obtain two out of three of the following required scores for each questionnaire:\n\n  * Greater than or equal to 15 for ISI (Gagnon, Belanger, Ivers, \\& Morin, 2013)\n  * Greater than or equal to 6 for PSQI (Buysse et al 1989)\n  * Greater than or equal to 11 for ESS (Johns, 2000)\n\nExclusion Criteria:\n\n* Presence of any metal implant or medical device which may pose a safety risk for MRI or TMS (see below for examples)\n\n  * Cardiac pacemakers\n  * Metal clips on blood vessels (also called stents)\n  * Artificial heart valves\n  * Artificial arms, hands, legs, etc.\n  * Brain stimulator devices\n  * Implanted drug pumps\n  * Ear implants\n  * Eye implants or known metal fragments in eyes\n  * Exposure to shrapnel or metal filings (wounded in military combat, sheet metal workers, welders, and others)\n  * Other metallic surgical hardware in vital areas\n  * Certain tattoos with metallic ink\n  * Certain transdermal (skin) patches such as NicoDerm (nicotine for tobacco dependence), Transderm Scop (scopolamine for motion sickness), or Ortho Evra (birth control)\n* Past or present history of sleep or breathing-related disorders such as sleep apnea (exclusion upon obtaining a score of 3 or higher on the STOP-BANG questionnaire)\n* Travel outside the time zone within the two weeks prior to enrollment visit and at any point while active in the study\n* Self-reported major medical problems including past or present history of heart problems and\u002For neurological problems (to include but not limited to heart murmur, heart attack, TBI, stroke, tumor, epilepsy or another seizure disorder)\n* Self-reported past or present history of cardiovascular disease (to include but not limited to arrhythmias, valvular heart disease, congestive heart failure, history of sudden cardiac death or myocardial infarction)\n* Self-reported past or present history of neurological disorder (to include but not limited to traumatic brain injury including concussions, strokes, tumors, epilepsy or another seizure disorder, amnesia for any reason, hydrocephalus, multiple sclerosis)\n* Self-reported past or present history of any seizures or seizure disorders\n* Self-reported first-degree family history (like a mother, father, or sibling) of a seizure or seizure disorder\n* Self-reported underlying acute or chronic pulmonary disease requiring daily inhaler use\n* Self-reported history of fainting spells or syncope\n* Self-reported past (at any point in the participant's history) or present psychiatric problems not including depression and\u002For anxiety disorders (to include but not limited to bipolar, mania, ADHD, or psychotic disorders)\n* Self-reported history of depression and\u002For anxiety disorders within the past 2 years\n* Self-reported suicidal ideation as indicated by a score equal to or greater than 2 on the BDI\n* Self-reported current use of certain prescription medications including Ambien, benzodiazepines, stimulants (amphetamines, medication for narcolepsy), antidepressants (SSRIs, SNRIs), antipsychotics, blood pressure medications, thyroid medications.\n* Self-reported current use of supplements that may affect sleep (to include but not limited to melatonin, valerian root, kava root)\n* Self-reported caffeine use in excess of 300 mg (e.g., approximately 8 caffeinated sodas or approximately 3-4 12-oz cups of coffee) per day on average\n* Self-reported or suspected regular nicotine use (or addiction) (defined as more than 1 cigarette or equivalent per week within the last 1 year)\n* Self-reported or suspected heavy alcohol use (minimum limit to define heavy alcohol use is 14 drinks per week)\n* Self-reported or suspected use of illicit drugs (to include but not limited to benzodiazepines, amphetamines, cocaine, opioids)\n* (Females only) Positive urine pregnancy result (Urine HCG Test results)\n* (Females only) Self-reported or suspected current breast-feeding or collecting breast-milk\n* Learned English past age 3\n* Speaking English as a non-primary language\n* Less than 9th grade education\n* Unusual sleep schedules in past six months\n* Overnight shift work\n* Inability to read and sign consent\n* Failure to cooperate with requirements of the study","50 Years",{"count":110,"type":20},20,[23],"Insomnia is generally believed to be caused by excessive arousal of the brain and body. Rather than transitioning normally and quickly from wakefulness to sleep, individuals with insomnia tend to enter into a self-perpetuating cycle of self-referential thought and arousal. Brain imaging research has shown that these same internally focused self-reflective thoughts tend to activate a core system in the brain known as the Default Mode Network (DMN). The DMN is usually active when a person is internally focused, such as during daydreaming or mind wandering, but tends to be deactivated when the brain is focused on the external environment. The investigators hypothesize that excess activation and connectivity of this brain network may perpetuate internal conversations, worry, and rumination, preventing individuals with insomnia from falling asleep quickly and remaining asleep. Therefore, the goal of the present study is to use a brain stimulation technique known as transcranial magnetic stimulation (TMS) to target the DMN and slightly reduce its activation before bed. This should result in an easier time falling asleep.\n\nFor this study, the investigators will recruit 20 healthy individuals and have them sleep in the lab on two occasions. On one occasion, they will be stimulated with a type of TMS called continuous theta burst stimulation (cTBS), which will be targeted toward their DMN. They will then try to sleep in the lab while the investigators record their brain waves using a technique known as polysomnography (PSG). On the other occasion, these same individuals will undergo the same procedure, but the TMS machine will be in a deactivated mode to present a \"sham\" stimulation. Participants will again try to sleep in the lab following the sham treatment while being recorded with PSG. Neither the participants nor the experimenters will know which condition the participant is receiving at the time. This will only be revealed later. Additionally, all participants will receive a brain scan just before and just after the TMS procedures so that the investigators can examine changes in brain connectivity and chemistry. The investigators expect that the participants will sleep better following the cTBS than following the sham condition and that this will be associated with measurable differences in their brain connectivity and brain chemistry.\n\nIf effective, this project would have identified an innovative and novel approach for improving sleep without using drugs.",[26],"2022-08-15",{"date":116,"type":31},"2022-08-17",{"date":118,"type":31},"2021-08-06",{"date":120,"type":20},"2022-08-31",{"name":122,"class":38},"University of Arizona",1]