[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sleep-disorders-circadian-rhythm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sleep-disorders-circadian-rhythm":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,40,67,96,176,199,220,251,273],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"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":39},"100493193","early-phase-1-effect-of-melatonin-on-sleep-patterns-of-resident-trainees-during-night-float-shift-100493193",false,"NCT05701969","Effect of Melatonin on Sleep Patterns of Resident Trainees During Night Float Shift","Inclusion Criteria:\n\n* Post-Graduate Year 1-5\n* Current enrollment in anesthesiology, general surgery, obstetrics and gynecology, general medicine, or pediatrics residency at the Unversity of Virginia\n\nExclusion Criteria:\n\n* Current use of sleep aids\n* Diagnosed sleep disorder\n* History of a pacemaker or other medical device.\n* pregnant or breast-feeding females\n* Bleeding disorders\n* Depression\n* High blood pressure\n* Seizure disorders\n* History of transplant on immunosuppression therapy.",true,"ALL","18 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","Anesthesiology residency requires extended and overnight shifts, which may negatively impact the quantity and quality of sleep.\n\nPrevious studies have investigated the effect of night float shift work on anesthesiology resident sleep and performance and demonstrated that total sleep quantity and time spent in deep and rapid eye movement (REM) sleep were significantly reduced during night float and did not return to baseline after 3 nights of recovery.\n\nMelatonin is a hormone produced by the pineal gland, which regulates the circadian rhythm that governs sleep. Exogenous melatonin may be used as a sleep aid and is available over the counter in the United States. Melatonin is effective in realigning the circadian rhythm disorder caused by night shift work and increasing sleep duration; however, melatonin's effect on improving sleep in resident trainees has not been investigated. The investigators propose a prospective double-blinded randomized control trial to investigate the effect of melatonin on sleep quantity and quality in resident physicians assigned to a night float system.",[26],"Sleep Disorders, Circadian Rhythm","RECRUITING","2026-04-27",{"date":30,"type":31},"2026-05-04","ACTUAL",{"date":33,"type":31},"2022-05-30",{"date":35,"type":20},"2028-06-30",{"name":37,"class":38},"University of Virginia","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":66},"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":49,"type":20},70,[51],"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.",[54,26,55],"Sleep Wake Disorders","Chronobiology Disorders","2025-11-24",{"date":58,"type":31},"2025-12-02",{"date":60,"type":31},"2020-12-09",{"date":62,"type":20},"2026-06",{"name":64,"class":65},"Vanda Pharmaceuticals","INDUSTRY",17,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":39},"100458246","phase-4-the-role-of-circadian-factors-in-regulation-of-neuroplasticity-in-ischemic-stroke-interventional-100458246","NCT05247125","The Role of Circadian Factors in Regulation of Neuroplasticity in Ischemic Stroke (Interventional)","Inclusion Criteria:\n\n* acute (symptom onset to admission \\\u003C1 days) ischemic stroke\n* ischemic stroke affecting the branches of anterior cerebral artery, middle cerebral artery and posterior cerebral artery\n* age 18-80 years\n* moderate or severe stroke (National Institutes of Health Stroke Scale, NIHSS\\>=5)\n* intravascular stroke treatment with thrombolysis or thrombectomy leading to satisfactory reperfusion (if applicable)\n* informed consent\n\nExclusion Criteria:\n\n* secondary parenchymal hemorrhage (\\>hemorrhage index (HI)-2)\n* clinically unstable or life-threatening conditions\n* previous stroke in the last 6 months\n* known progressive neurological diseases\n* known psychiatric diseases\n* concomitant benzodiazepine medication\n* drug or alcohol abuse\n* pregnancy\n* inability to participate in the study\n* severe sensory aphasia\n* melatonin intake at\u002Fbefore admission\n* light therapy use at\u002Fbefore admission\n* blindness\n* severe sleep-disordered breathing (apnea-hypopnea index \\>=30\u002Fh)\n* contraindications to light therapy (severe retinopathy, epilepsy, porphyria, intake of drugs with photosensitizing effects)\n* contraindications to melatonin intake (severe bronchial asthma, severe autoimmune disorders, chronic kidney disease 3b stage and higher, leukosis)\n* congestive heart failure with reduced ejection fraction (\\\u003C=45%) or New York Heart Association (NYHA) classification III-IV functional class.","80 Years",{"count":75,"type":20},80,[77],"PHASE4","There is a lack of complex studies which could establish the association between genetic circadian factors with the features and short-term outcomes of ischemic stroke, as well as the effects of various auxiliary therapies for circadian rhythm modulation for neuroplasticity enhancement and improvement of short-term outcomes in ischemic stroke.\n\nThe main research hypothesis is that circadian factors influence the recovery from ischemic stroke via sleep-mediated regulation of synaptic plasticity.\n\nThe project aims at the investigation of the influence of combined melatonin therapy and blue light exposure on molecular circadian biomarkers, sleep characteristics, neuroplasticity markers and stroke outcome in acute stroke patients.\n\nThis study is a prospective, interventional, randomized placebo-controlled trial.",[80,26],"Ischemic Stroke, Acute",[82,83,84,85,86],"circadian misalignment","neuroplasticity","melatonin","light therapy","circadian disorder","2025-08-05",{"date":89,"type":31},"2025-08-08",{"date":91,"type":31},"2022-03-01",{"date":93,"type":20},"2026-12-31",{"name":95,"class":38},"Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health",{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":108,"conditions":109,"keywords":146,"overallStatus":167,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":39},"100565622","phase-1-evaluating-the-efficacy-and-safety-of-prosomnia-sleep-therapy-in-patients-with-sleep-deprivation-and-chronic-insomnia-100565622","NCT06644573","Evaluating the Efficacy and Safety of PROSOMNIA Sleep Therapy™ in Patients With Sleep Deprivation and Chronic Insomnia","PSHW","By adhering to the following criteria, the study aims to select a population that can safely undergo the PROSOMNIA Sleep therapy and for whom the therapy is most likely to be beneficial, ensuring the reliability and validity of the study outcomes.\n\nINCLUSION CRITERIA:\n\n1. Age Range: 18-65 years of age Reason: This age range includes adults who are most likely to benefit from the PROSOMNIA Sleep therapy and who can provide informed consent. It also excludes children and older adults who may have different physiological responses or additional health risks.\n2. Diagnosed or Undiagnosed Chronic Insomnia:\n\n   Reason: Included subjects have a consistent pattern of sleep disturbances that PROSOMNIA Sleep Therapy aims to treat.\n3. Diagnosed or Undiagnosed Sleep Deprivation:\n\n   Reason: Includes individuals who are not getting enough sleep quantity, which is a key condition that the PROSOMNIA Sleep Therapy aims to address.\n4. Diagnosed or Undiagnosed REM Sleep Inconsistencies:\n\n   Reason: Includes individuals who are not getting enough sleep quality and those with specific REM sleep phase issues that the PROSOMNIA Sleep Therapy is designed to improve.\n5. Failure to Respond to Conventional Sleep Treatments:\n\n   Reason: Focuses on subjects who have not found relief from existing sleep therapies, ensuring that the study population represents those in need of alternative solutions.\n6. Ability to Provide Informed Consent:\n\nReason: Ensures that participants understand the study and agree to participate voluntarily.\n\nEXCLUSION CRITERIA:\n\n1. Severe Obesity (BMI \\> 40):\n\n   Reason: Severe obesity can increase the risk of complications with anesthesia and may affect sleep patterns in ways that could confound study results.\n2. Cardiovascular Conditions:\n\n   Reason: Patients with significant heart conditions are at higher risk for complications during anesthesia.\n3. Neurological Disorders:\n\n   Reason: These diagnosed conditions and medications such as epilepsy could interfere with sleep patterns and responses to sleep therapy.\n4. Other Health Conditions Contraindicating Anesthesia:\n\n   Reason: Includes any condition that would make the use of anesthesia unsafe.\n5. Greater than ASA II Status:\n\n   Reason: The American Society of Anesthesiologists (ASA) physical status classification system classifies patients based on their pre-anesthesia medical conditions. Excluding those above ASA II ensures that only patients with mild systemic disease are included, to minimize risks.\n6. Current Use of Prohibited Medications:\n\n   Reason: Medications that could interfere with the combined use of anesthesia including, but not limited to sedatives and hypnotics; such as benzodiazepines, Z-drugs and barbiturates.\n7. Pregnancy or Breastfeeding:\n\nReason: Ensures the safety of the fetus or infant, as the effects of the PROSOMNIA Sleep therapy on pregnancy or lactation are unknown.","65 Years",{"count":105,"type":20},100,[107],"PHASE1","This clinical trial aims to evaluate the safety and efficacy of PROSOMNIA Sleep Therapy (PSTx) for individuals suffering from chronic insomnia, sleep deprivation, and REM sleep disorders. Chronic insomnia, characterized by difficulty falling or staying asleep, significantly affects patients and quality of life, mood, and cognitive function. REM sleep disorders, in which the body struggles to enter or maintain restful REM sleep, can worsen these issues. The trial introduces a novel therapy using anesthesia-induced sleep, targeting sleep homeostasis and improving sleep architecture.\n\nObjectives: The primary goals of the trial are to determine:\n\n1. Whether PROSOMNIA Sleep Therapy increases the quality of REM sleep.\n2. Whether PSTx increases the duration of REM and\u002For NREM sleep.\n3. Whether PSTx decreases the time it takes participants to fall asleep (sleep onset latency).\n\nParticipants will receive ONE (1) PROSOMNIA Sleep Therapy session lasting between 60-120 minutes. Each session uses Diprivan\u002FPropofol to induce sleep, and is monitored via an EEG to ensure proper sleep stages, particularly REM sleep.\n\nParticipant Criteria:\n\nInclusion: Adults aged 18-65 with diagnosed or undiagnosed chronic insomnia or sleep deprivation.\n\nExclusion: Patients with severe obesity, significant cardiovascular, neurological, or psychiatric conditions, or those with an ASA status above II.\n\nStudy Design: This trial is non-randomized, single-arm and open-label, with all participants receiving the PSTx. The trial does not include a comparison group, as the focus is on evaluating the immediate, direct effects of the therapy.\n\nParticipants will undergo continuous EEG monitoring during therapy sessions, allowing researchers to track brain activity and sleep stages in real-time. This method ensures that sleep cycles, particularly REM sleep, are optimized for therapeutic benefit.\n\nTherapy Methodology:\n\nPROSOMNIA Sleep Therapy leverages anesthesia to mimic natural sleep patterns and enhance the efficiency of REM sleep. Diprivan\u002FPropofol is used to induce REM sleep, while EEG monitoring tracks and maintains proper sleep architecture throughout the session. The therapy promotes the clearance of adenosine, a compound that builds up during wakefulness and drives the need for sleep. Adenosine is cleared during REM sleep, reducing sleep pressure and improving cognitive function.\n\nOutcome Measures:\n\nPrimary Outcomes: Researchers will measure the increase in REM sleep duration, improvement in sleep quality (via self-reported questionnaires), and a reduction in sleep onset latency.\n\nSecondary Outcomes: These include changes in mood, cognitive function, and blood serum uric acid levels. Patient-reported outcomes will also be tracked through tools like the PROSOMNIA Sleep Quiz, which is specifically designed for PSTx.\n\nSignificance: Chronic insomnia and REM sleep disorders affect millions globally, leading to cognitive impairment, mood disturbances, and poor overall health. Traditional treatments, including pharmacological approaches and Cognitive Behavioral Therapy for Insomnia (CBT-I), often provide suboptimal results for many individuals. PSTx offers a novel, therapeutic approach to restoring sleep balance and enhancing the overall quality of sleep, particularly for those who have not responded to conventional treatments.\n\nStudy Process:\n\nRecruitment and Baseline Assessments: Participants undergo a comprehensive sleep assessment, including sleep questionnaires and polysomnography, to establish a baseline for sleep quality and duration. Blood serum uric acid levels will also be measured to track any biochemical changes due to therapy.\n\nTherapy Sessions: Only one (1) PROSOMNIA Sleep Therapy session will be administered, with the session lasting between 60-120 minutes. Diprivan\u002FPropofol is used to induce sleep, and EEG will monitor brain activity to ensure the proper balance of sleep stages.\n\nPost-Therapy Follow-up: Follow-up assessments will occur at 24 hours, 7 days, and 30 days post-treatment. Researchers will analyze the therapy effects on REM sleep, mood, cognitive function, and other health indicators.\n\nPotential Implications: If successful, this trial could revolutionize how we treat sleep disorders by targeting the underlying mechanisms of sleep pressure and REM sleep disruption. PROSOMNIA Sleep Therapy may offer a safe, effective, and immediate alternative for patients who have exhausted other treatment options.\n\nKey Concepts:\n\nHomeostatic sleep drive, (Process S), caused by adenosine buildup during wakefulness, is disrupted by chronic insomnia. This impacts cognitive function health and recovery. Anesthesia-induced REM sleep via PSTx helps regulate this homeostatic sleep stage, offering deeper and more restorative sleep compared to other sleep therapies. The study uses statistical methods like ANOVA and Chi-square to measure outcomes.",[110,111,112,113,114,115,116,117,118,119,120,121,122,26,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145],"Chronic Insomnia","Sleep Deprivation","REM Behavior Disorder","REM Sleep Behavior Disorder","REM Sleep Measurement","Insomnia","Insomnia Related to Specified Disorder","Insomnia Due to Other Mental Disorder","Insomnia Comorbid to Psychiatric Disorder","Insomnia Due to Anxiety and Fear","Insomnia Related to Another Mental Condition","Insomnia Disorders","Idiopathic Hypersomnia","Post Trauma Nightmares","PTSD - Post Traumatic Stress Disorder","Sleep Quality","Anesthesia","Anxiety","Depression","Mental Health","Alzheimer Disease or Associated Disorder","Parkinsons","Circadian Rhythm","Circadian Dysregulation","PTSD","Post-Traumatic","Post-Traumatic Stress Disorder Complex","Military Combat Stress Reaction","Sleep","Military Activity","Veterans","Shift Work Sleep Disorder","Menopause Related Conditions","Pain","Cancer Pain","Athletes",[147,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,115,111,165,122,166,134,129,127,128],"SLEEP","PROSOMNIA Sleep","PROSOMNIA Sleep Therapy","PSTx","PROSOMNIA","Anesthesia Sleep","REM Sleep","REM Sleep Therapy","PROSOMNIA Sleep Health","PROSOMNIA Sleep Wellness","PROSOMNIA Sleep Treatment","Nyree","Nyree Penn","Propofol","Propofol Sleep","Diprivan","Diprivan Sleep","PROSOMNIA Sleep Health and Wellness","IH","Sleep Debt","NOT_YET_RECRUITING","2025-05-27",{"date":170,"type":31},"2025-05-28",{"date":172,"type":20},"2025-11-01",{"date":174,"type":20},"2026-05-01",{"name":159,"class":65},{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":182,"enrollmentInfo":183,"targetDuration":4,"studyType":185,"phases":4,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":167,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":4},"100589388","a-prospective-study-the-impact-of-sleep-disturbances-on-immunotherapy-in-patients-with-lung-cancer-100589388","NCT06953765","A Prospective Study: the Impact of Sleep Disturbances on Immunotherapy in Patients With Lung Cancer","Inclusion Criteria:\n\nDiagnosis of non-small-cell lung cancer (stage II-IV) Age 18 and older Immune checkpoint inhibitor therapy (e.g., nivolumab, pembrolizumab, etc.) is planned.\n\nBe able to understand the study and provide informed consent\n\nExclusion Criteria:\n\nCoexisting serious mental illness (e.g., major depression, anxiety, etc.) Recent chemotherapy or radiotherapy Other serious comorbidities (e.g., heart disease, liver and kidney insufficiency)","70 Years",{"count":184,"type":20},350,"OBSERVATIONAL","In recent years, immunotherapy has made significant progress in the treatment of lung cancer, especially immune checkpoint inhibitors (such as PD-1\u002FPD-L1 antibodies) against non-small cell lung cancer (NSCLC). However, there are significant individual differences in patient response to treatment. Studies have shown that sleep disorders may affect the function of the immune system, thereby affecting tumor progression and treatment response. Therefore, the aim of this study was to evaluate the impact of sleep disturbances on lung cancer patients receiving immunotherapy.",[188,26,189],"Lung Cancer (NSCLC)","PD-1","2025-04-29",{"date":192,"type":31},"2025-05-01",{"date":194,"type":20},"2025-06-01",{"date":196,"type":20},"2028-12-30",{"name":198,"class":38},"Shanghai Zhongshan Hospital",{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":206,"targetDuration":4,"studyType":21,"phases":208,"briefSummary":209,"conditions":210,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":39},"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":207,"type":20},60,[51],"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.",[54,26,55,211],"Gene Mutations and Other Alterations Nec","2024-11-19",{"date":214,"type":31},"2024-11-22",{"date":216,"type":31},"2024-10-08",{"date":218,"type":20},"2025-06-30",{"name":64,"class":65},{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":224,"acronym":225,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":185,"phases":4,"briefSummary":229,"conditions":230,"keywords":241,"overallStatus":167,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":39},"100566342","study-of-sleep-quality-in-the-intensive-care-unit-and-association-with-weaning-from-invasive-ventilation-in-patients-with-chronic-obstructive-bronchopneumopathy-100566342","NCT06653933","Study of Sleep Quality in the Intensive Care Unit and Association with Weaning from Invasive Ventilation in Patients with Chronic Obstructive Bronchopneumopathy.","SLEECOP","Inclusion Criteria:\n\n* Patients diagnosed with COPD according to the GOLD criteria.\n* Mechanical ventilation by endotracheal tube and mechanical ventilation for \\> 24 hours.\n* Withdrawal of treatment with continuous sedation and\u002For neuroleptics.\n* Adequate recovery with Glasgow Coma Scale ≥ 8.\n\nExclusion Criteria:\n\n* Patients with central nervous system damage or neuromuscular pathology.\n* Pregnant or postpartum patients.\n* Patients or their relatives who object to participating in the study.",{"count":228,"type":20},42,"Patients admitted in ICU may require invasive mechanical ventilation, using a mechanical ventilator and an endotracheal tube.\n\nIn ICU, a prolonged duration of invasive mechanical ventilation may be responsible for ventilator-induced lung injury, pulmonary infection, prolonged administration of sedation, neuromyopathy and prolonged length of stay. The goal of the ICU healthcare teams is therefore to reduce the duration of invasive mechanical ventilation as much as possible.\n\nICU patients have many sleep disturbances: sleep fragmentation, sleep stage changes, changes in sleep architecture. These sleep disturbances are due to sedation and analgesia, delirium, patient care activities, noise and altered day-night cycles.\n\nChronic obstructive pulmonary disease (COPD) is a common respiratory disease. COPD complicates the management of invasive mechanical ventilation, particularly weaning of this invasive mechanical ventilation and extubation (removal of the intubation tube).\n\nTo reduce the risk of reintubation, it is recommended that a weaning test is performed prior to extubation. The purpose of this test is to simulate the conditions of breathing without the help of a ventilator after extubation. If the weaning test is successful, the patient can theoretically be extubated.\n\nThere are several causes associated with extubation failure, but studies suggest that sleep deprivation or poor sleep quality in the nights before extubation is one of them. In addition, patients with COPD often have chronic sleep disturbances or induced by their stay in the ICU (asthenia, bed rest, anxiety, sedation, etc.).\n\nThe aim of our study will be to compare the sleep characteristics of COPD patients with a failed weaning test and those with a successful test. Our hypothesis is that patients with a failed weaning test will have more sleep disturbances in the period of 72 hours before the weaning test.",[231,232,233,234,235,236,125,26,237,238,239,240],"COPD","COPD Exacerbation","Ventilated Patients","Ventilator-Associated Pneumonia (VAP)","Ventilator Weaning","Weaning of Mechanical Ventilation","Sleep Disorders","Failure, Respiratory","ICU Hospitalization","ICU Sedation",[231,125,236],"2024-10-21",{"date":244,"type":31},"2024-10-23",{"date":246,"type":20},"2025-01-01",{"date":248,"type":20},"2027-07-01",{"name":250,"class":38},"University Hospital, Grenoble",{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":255,"acronym":256,"eligibilityCriteria":257,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":258,"enrollmentInfo":259,"targetDuration":4,"studyType":185,"phases":4,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":39},"100552463","electroencephalography-and-sleep-quality-with-lormetazepam-in-the-intensive-care-unit-100552463","NCT06473415","Electroencephalography and Sleep Quality With Lormetazepam in the Intensive Care Unit","CLIO-ICU","Inclusion Criteria:\n\n* Patient capable of giving consent or additional legal guardian\u002Fauthorized representative\u002Fspouse available for non-consenting patient in the intensive care unit\n* An expected continuous lormetazepam therapy ≥ 24 hours\n* Male and female patients aged ≥18 years\n* Expected duration of intensive care treatment ≥ 48 hours\n* Mechanical ventilation (invasive, NIV and\u002For nasal high-flow \\> 6h)\n\nExclusion Criteria:\n\n* Laboratory evidence of sedative\u002Fopiate intoxication\n* Active alcohol abuse\n* Brain surgery, cranial malformation\n* History of sleep-related movement disorder (symptomatic restless legs syndrome)\n* Allergy to electrode contact material\n* History of severe cognitive impairment following a stroke\n* Status post cardiopulmonary resuscitation requiring\u002Fundergoing therapeutic hypothermia\n* Lack of consent for the pseudonymized disease data to be stored and passed on in the context of this clinical study\n* Patient is housed in an institution on court or official order\n* History of sleep-related breathing disorder\n* Suspicion of hypoxic brain damage (including intracranial hemorrhages)\n* Suspicion of increased intracranial pressure\n* Existing power of attorney or patient's will, in which the patient fundamentally excludes participation in studies\n* The patient's consent or that of the legal representative cannot be obtained in a timely manner\n* Patients with a survival probability \\\u003C 24h\n* Narcolepsy","100 Years",{"count":19,"type":20},"The goal of this clinical trial is to test the effect of continuous lormetazepam infusion on EEG patterns in critically ill patients who are given continuous infusion of lormetazepam in an intensive care unit setting. The main questions it aims to answer are:\n\n• How does the continuous infusion of lormetazepam affect EEG readings in terms of specific patterns related to sleep quality and sedation depth?\n\nParticipants will be asked to:\n\n* Receive continuous infusion of lormetazepam, administered as per the guidelines and judgment of the on-duty ward physician.\n* Undergo up to three EEG measurements over a period of 24 hours each using the X8 Sleep Profiler RTA device. These measurements will monitor brain activity and other related signals in order to assess the sedation depth and sleep quality.\n* These EEG readings will be performed after at least two hours of initiation of continuous lormetazepam infusion, potentially at different stages of their ICU stay.\n\nThere is no direct comparison group in this study. However, after initial data from the first 15 patients is collected, an interim analysis will be performed. This will help researchers understand the ability to measure sleep quality and defined EEG parameters in this setup, and if necessary, adapt the study design or measurement procedures for better outcomes.",[262,263,26],"Critical Illness","Delirium","2024-06-24",{"date":266,"type":31},"2024-06-26",{"date":268,"type":31},"2023-12-01",{"date":270,"type":20},"2024-12-31",{"name":272,"class":38},"Charite University, Berlin, Germany",{"id":274,"slug":275,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":15,"sex":16,"minAge":280,"maxAge":17,"enrollmentInfo":281,"targetDuration":4,"studyType":185,"phases":4,"briefSummary":282,"conditions":283,"keywords":287,"overallStatus":167,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":4},"100366720","influence-of-circadian-clock-on-hormonal-metabolic-neurocognitive-markers-in-adolescents-with-and-without-diabetes-100366720","NCT04054934","Influence of Circadian Clock on Hormonal, Metabolic, Neurocognitive Markers in Adolescents With and Without Diabetes","Influence of Circadian Clock on Diurnal Dietary Intake, Glucose Variability, Time Spent in Range, and Neuro-cognitive Achievements Among Adolescents With and Without Type 1 Diabetes","Inclusion Criteria:\n\n* Families living in areas with high access to medical care.\n* Age: 12-18 years old\n* T1D diagnosis for longer than 1 year\n* speaking fluent Hebrew\n\nExclusion Criteria:\n\n* significant renal or liver function abnormalities\n* head injuries,\n* epileptic episodes\n* psychiatric medications\n* lack of Hebrew abilities\n* disagreement to comply with all the study requests\n* history of more than one episode of a severe hypoglycemic event in the past, including loss of consciousness or more than one episode of diabetic ketoacidosis.","12 Years",{"count":105,"type":20},"Type 1 diabetes mellitus (T1DM), makes its appearance during childhood and youth, but management implications last till late adulthood. Its treatment includes the combination of multiple daily glucose measurements, insulin administration and balanced nutrition. The goals of therapy are to achieve glycemic control (HbA1c \\\u003C 7.5%), and minimal glycemic excursions. Furthermore, recent studies imply that keeping HbA1c within target range is not sufficient to prevent complications, attributed mainly to blood glucose level fluctuating from high to low, associated with food intake and adolescents behavior. The current implication of glycemic control on the central nervous system (CNS) includes abnormal electrical brain activity, structural changes in brain's white and grey matter, and cognitive impairment. Still, little is known on the effect of sleep pattern, including circadian rhythm reversal (\"biological clock) on asymptomatic glycemic excursions, and on CNS functions. There is no data regarding the association of the biologic clock on CNS functionality among adolescents, nonetheless among T1DM adolescents, for whom behavior and circadian rhythm alterations may have harmful effect. The investigators propose a cross-over designed study by examining adolescents with and without T1DM during 2 weeks of regular sleeping pattern (night sleep), and during 2 weeks of sleeping during the day as happens during summer vacation. The main objective of the proposed study is to offer proof of the clinical and metabolic relevance and cognitive effects of the reversal of the circadian clock in adolescents with and T1DM during summer vacations and weekends. Study is designed to demonstrate a difference among healthy and diabetics during reversed night\u002Fday circadian clocks in the time spent within target range of glucose, performance on neuro cognitive tasks, electrical brain activity, and hormonal profile.",[284,26,285,286],"T1DM","ADHD","Memory Impairment",[284,288,289,290,291,292],"Hypothalamus","CORTICAL BRAIN","Glucose variability","Biological clock","Pediatrics","2020-05-22",{"date":295,"type":31},"2020-05-26",{"date":297,"type":20},"2022-01",{"date":299,"type":20},"2026-12",{"name":301,"class":302},"Assaf-Harofeh Medical Center","OTHER_GOV"]