[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"excessive-daytime-sleepiness\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:excessive-daytime-sleepiness":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,56,91,119,160],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":34,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100511439","impact-of-bright-light-therapy-on-prader-willi-syndrome-100511439",false,"NCT05939453","Impact of Bright Light Therapy on Prader-Willi Syndrome","A Randomized, Double-Blind, Controlled Trial of Bright Light Therapy on All-Cause Excessive Daytime Sleepiness in Prader-Willi Syndrome","PWS-LT","Inclusion Criteria:\n\n* Diagnosis of PWS confirmed by genetic testing\n* Score of 12 or above on the Epworth Sleepiness Scale (ESS).\n\nExclusion Criteria:\n\n* Subjects with an eye condition that could be negatively affected by bright light such as patients with a history of retinal damage or patients needing photosensitizing medications\n* A history of previous treatment with LT\n* Patients presenting with active psychosis or mania","ALL","6 Years","88 Years",{"count":21,"type":22},50,"ESTIMATED","INTERVENTIONAL",[25],"NA","This is a placebo controlled clinical trial to assess the utility of light therapy as a sufficient treatment for excessive daytime sleepiness in patients with Prader-Willi Syndrome",[28,29,30,31,32,33],"Prader-Willi Syndrome","Excessive Daytime Sleepiness","Hyperphagia","Body Weight","Mood","Behavior",[35,36,37,38,39,40,41,42],"Light Therapy","Aberrant Behavior Checklist","Clinical Global Impression- Improvement","Fitbit","Actigraphy reports","Epworth Sleepiness Scale","Hyperphagia Questionnaire (HQCT)","Modified Overt Aggression Scale (MOAS)","RECRUITING","2026-05-13",{"date":46,"type":47},"2026-05-15","ACTUAL",{"date":49,"type":47},"2023-10-01",{"date":51,"type":22},"2026-12",{"name":53,"class":54},"Maimonides Medical Center","OTHER",1,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":17,"minAge":63,"maxAge":4,"enrollmentInfo":64,"targetDuration":66,"studyType":67,"phases":4,"briefSummary":68,"conditions":69,"keywords":73,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":55},"100639881","sleep-and-stroke-rehabilitation-study-100639881","NCT07579871","Sleep and Stroke Rehabilitation Study","SnSRehabS","Inclusion Criteria:\n\n* Ischemic stroke.\n* First time stroke.\n\nExclusion Criteria:\n\n* Short expected survival.\n* Unable to carry HSAT equipment (e.g., gel nails; the patient is wearing other medical devices; motor or cognitive impairment without the possibility of assistance from healthcare staff or relatives).\n* Reduced understanding of the project due to insufficient Swedish, which cannot be bridged with an interpreter.","18 Years",{"count":65,"type":22},226,"9 Months","OBSERVATIONAL","The study aims to map sleep disorders and their impact on the ability to engage in an active daily life among people who have had a stroke, with particular focus on how sleep apnea can be identified.\n\nThe study has the following objectives:\n\n1. To examine the occurrence of sleep apnea, insomnia, excessive daytime sleepiness, and restless legs syndrome\u002Fperiodic limb movements in patients with ischemic stroke three months after onset.\n2. To investigate associations between these sleep disorders and physical and mental health, fatigue, quality of life, cognitive and physical function, and daily physical behavior including physical activity levels.\n3. To identify which clinical factors and patient reported data, including patient reported data from commercial wearable health technology, predict a diagnosis of sleep apnea.\n4. To examine how sleep disorders affect changes in physical and mental health, fatigue, quality of life, cognitive and physical function, and daily physical behavior including physical activity levels one year after stroke.",[70,71,72,29],"Stroke","Sleep Apnea Syndrome (OSAS)","Insomnia",[74,75,76,77,78,79,80,81],"actigraphy","HSAT","Quality of life","rehabilitation","recovery","smartwatch","sleep","stroke","2026-05-06",{"date":84,"type":47},"2026-05-12",{"date":86,"type":47},"2026-03-18",{"date":88,"type":22},"2028-10-30",{"name":90,"class":54},"Malin Eleonora av Kák Gustafsson, MD, PhD",{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":98,"sex":17,"minAge":63,"maxAge":99,"enrollmentInfo":100,"targetDuration":4,"studyType":23,"phases":102,"briefSummary":104,"conditions":105,"keywords":106,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":118},"100599310","phase-1-a-study-of-orx142-in-healthy-adult-subjects-including-subjects-18-to-80-years-of-age-100599310","NCT07082829","A Study of ORX142 in Healthy Adult Subjects, Including Subjects 18 to 80 Years of Age","A Randomized, Double-blind, Sponsor-open, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single and Multiple Ascending Doses of ORX142 in Healthy Adults, Single Doses of ORX142 in Healthy Older Adults, and a Single Dose Crossover, Proof-of-concept Study of ORX142 in Acutely Sleep-deprived Healthy Subjects","Key Inclusion Criteria:\n\n1. Healthy males or females as determined by assessments at the Screening Visit.\n\n   For Parts A, B, C, and E:\n\n   a. Participants must be at least 18 years of age and no more than 55 years of age at the Screening\n2. For Part D:\n\na .Participants must be at least 60 years of age and no more than 80 years of age at the Screening\n\nKey Exclusion Criteria:\n\n1. Presence of significant cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, malignancy, endocrine, neurological, or psychiatric disease, as determined by medical history, physical examination, and screening investigations.\n2. History of seizure disorder, any other condition that increases the risk of seizure\n3. Has a clinically significant sleep disorder, including insomnia or sleep apnea.",true,"80 Years",{"count":101,"type":22},208,[103],"PHASE1","Characterize the safety, tolerability and pharmacokinetics of ORX142 following single and multiple doses.",[29],[29,107],"orexin-2 receptor agonist","2025-12-17",{"date":110,"type":47},"2025-12-24",{"date":112,"type":47},"2025-06-30",{"date":114,"type":22},"2026-06-15",{"name":116,"class":117},"Centessa Pharmaceuticals (UK) Limited","INDUSTRY",3,{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":98,"sex":17,"minAge":63,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":23,"phases":129,"briefSummary":130,"conditions":131,"keywords":137,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":156,"leadSponsor":158,"locationsCount":55},"100583151","validating-a-novel-driving-simulation-based-mwt-against-the-standard-mwt-in-an-osa-cohort-challenged-by-cpap-withdrawal-100583151","NCT06872593","Validating a Novel Driving Simulation-based MWT Against the Standard MWT in an OSA-cohort Challenged by CPAP-withdrawal","Validating a Novel Driving Simulation-based MWT Against the Standard MWT in an OSA-cohort Challenged by CPAP-withdrawal - a Monocentric, Controlled, Randomized, Crossover Trial","DS-MWT2","Inclusion Criteria (OSA patients): adult drivers, diagnosed OSA, established CPAP-treatment regime, highly adherent and compliant within the last 6 months (\\>5h, \\>80% of days), at impaired eyesight with more than +\u002F- 5 diopter or astigmatism, contact lenses are required (for eye tracking)\n\nInclusion criteria (healthy comparison croup): adult drivers, no declared psychiatric disorders, no declared sleep-related diagnosis, at impaired eyesight with more than +\u002F- 5 diopter or astigmatism, contact lenses are required (for eye tracking)\n\nExclusion criteria (for both groups): sensibility to motion sickness (kinetosis, dizziness, etc. in 5 min screening drive), professional drivers (if working during the study period), inability to understand the study procedure for linguistic or cognitive reasons.",{"count":128,"type":22},54,[25],"In brief, the proposed study will evaluate a recently proposed naturalistic, driving simulation test to identify and measure sleepiness behind the wheel, one of the most underestimated causes of road accidents. The proposed test offers higher ecological validity and might complement somnological tests that are standard, but rarely performed. Thus, the test might provide traffic medicine and sonologists with an effective tool, that can also directly convey the risks of excessive daytime sleepiness to drivers and thus, in combination, effectively aid in traffic medicine's mandate to avoid preventable road fatalities.\n\nExcessive daytime sleepiness (EDS) is a symptomatic condition resulting from too little or compromised sleep, caused by psycho-social stress (shiftwork, lifestyle) or medical conditions (obstructive sleep apnoea (OSA), narcolepsy). Driving with untreated EDS might lead to sleepy\u002Fdrowsy driving and microsleep, which is considered to be one of the highest-ranking causes of road accidents. Sleepiness and its dangers on the wheel might subjectively not be registered by the affected drivers. Also, subjective sleepiness might not correlate with somnological measurements that are also crucial for legally determining the fitness to drive (FTD).\n\nThere exists a variety of partially complementary tools to evaluate the extent of EDS. Mean sleep latency obtained in the maintenance of wakefulness test (MWT) is widely, but not uniformly, considered to be one of the most objective measures to evaluate EDS, especially in the context of driving performance. However, there is inconsistent or insufficient evidence for MWTs to reliably predict the FTD in general, potentially as its result might be strongly influenced by motivation. Moreover, patients might not relate low mean MWT-latencies to their own and other's risks in traffic.\n\nA need for improved tools to measure EDS was formulated. It remains open, whether the MWT should be replaced or complemented by, for example, future road-side metabolomics-tests detecting sleepiness in traffic or whether the MWT should be adapted to better convey a.) the risks of EDS in traffic and b.) its meaning for the determination of the FTD.\n\nWith this need in mind the investigators proposed furnishing the maintenance of wakefulness test with improved ecological validity to provide an improved tool for the assessment of the effect of excessive daytime sleepiness on the fitness to drive: recently published results from an exploratory feasibility study suggested it to be well possible to transfer the MWT-paradigm to a driving simulator (DS) with high user acceptance. The published result's implication and relevance was well received: the new test, DS-MWT, might complement somnological MWTs in pneumology and neurology. I might provide a naturalistic and relatable tool to determine EDS in traffic medicine, who is institutionally responsible for determining the FTD. This is also desirable, because prohibitively high cost - in time, money and instrumentation - often prevent a standard MWT in standard care of sleep-related medical conditions. Potentially, the use of the DS-MWT might help reduce the number of preventable road fatalities by more often identifying sleepy individuals before they get behind the wheel.\n\nHowever, for this goal to be achieve, it remains to be evaluated whether the latencies obtained in classical or simulation conditions are comparable and whether obtained latencies actually reflect other clinical parameters of EDS relating to underlying medical conditions, such as for example OSA. This represents a significant gap of evidence for both medical experts in pneumology and traffic medicine, but also for affected drivers. This gap will be filled by systematically comparing classical and simulation-based MWTs by means of their resulting latencies. In a within-study setup of 36 highly adherent OSA-patients, experiments will be related to a main medical comparator, a ≥7-day continuous positive airway pressure (CPAP)-withdrawal (W) and subsequent -resumption or continuation (C), respectively. There will be a control group of 18 healthy participants for comparison.",[29,132,133,134,135,136],"Obstructive Sleep Apnea (OSA)","CPAP Treatment","Driving Simulator Performance","Driving Impaired","CPAP",[80,138,139,140,141,142,143,144,145,146,147,148,149,150,151],"drowsy driving","sleepy driving","sleepiness behind the wheel","driving simulation","CPAP treatment","CPAP withdrawal","driving performance","sleep latency","maintenance of wakefulness test","MWT","microsleep","microsleep-like episodes","eye tracking","EEG-recording","2025-07-14",{"date":154,"type":47},"2025-07-17",{"date":152,"type":47},{"date":157,"type":22},"2027-04-30",{"name":159,"class":54},"Stefan Lakämper",{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":17,"minAge":63,"maxAge":4,"enrollmentInfo":166,"targetDuration":168,"studyType":67,"phases":4,"briefSummary":169,"conditions":170,"keywords":171,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":55},"100570739","sleepiness---a-search-for-a-biomarker-of-excessive-daytime-sleepiness-in-severe-obstructive-sleep-apnoea---an-explorative-study-100570739","NCT06711159","SLEEPINESS - a Search for a Biomarker of Excessive Daytime Sleepiness in Severe Obstructive Sleep Apnoea - An Explorative Study","Inclusion Criteria:\n\nFor a subject to be eligible, all inclusion criteria must be answered \"yes\":\n\n1. Age ≥18 years\n2. Subjects must be diagnosed with Severe Obstructive Sleep Apnea (AHI \\> 30) and have not yet started any form of PAP (positive airway pressure) treatment.\n3. ESS score must be above 10 at the time of inclusion.\n\nExclusion Criteria:\n\nFor a subject to be eligible, all exclusion criteria must be answered \"no\":\n\n1. Known severe neurological or psychiatric diseases.\n2. Known congestive heart failure, chronic renal failure, liver failure, malignancy, severe pulmonary disease.\n3. Considerable use of alcohol.\n4. Medication judged by investigator to influence sleep\u002Fwake regulation to such a degree that data quality will be compromised.\n5. Has cochlear implants.\n6. Involved in therapies with medical devices that deliver electrical energy into the area around the implant.\n7. Is at high risk of surgical complications, such as active systemic infection and haemorrhagic disease.\n8. Are unable (i.e. mentally or physically impaired patient), or do not have the necessary assistance, to properly operate the device system.\n9. Has an infection at the site of device implantation.\n10. Operates MRI scanners.\n11. Has a profession\u002Fhobby that includes activity imposing extreme pressure variations (e.g. diving or parachute jumping). NB: diving\u002Fsnorkelling is allowed to 5 metres depth.\n12. Has a profession\u002Fhobby that includes activity imposing an unacceptable risk for trauma against the device or the site of implantation (e.g. martial art or boxing).\n13. Other known diseases or conditions, judged by investigator to influence sleep to such a degree that data quality will be compromised.\n14. Incapable, judged by the investigator, of understanding the participant instruction or who are not capable of carrying through the investigation.\n15. Pregnancy or intention to become pregnant within the next 12 months.",{"count":167,"type":22},15,"12 Weeks","Study aim:\n\nThis study aims to use a new brainwave monitoring device that meassure brainwaves 24 hours a day to create better understanding of sleep-wake interplay as a biomarker for excessive daytime sleepiness because of obstructive sleep apnea.\n\nStudy Method, Design, and Procedures Patients with sleep apnea referred to the Sleep Clinic at the Department of Ear, Nose, Throat, and Jaw Surgery in Køge for CPAP treatment, who also experience severe daytime sleepiness, will be offered participation in this study. The goal is for 15 participants to complete the entire protocol.\n\nProcedure Overview Initial Sleep Assessment: The study begins with an in-depth sleep assessment through polysomnography (PSG) followed by a Multiple Sleep Latency Test (MSLT).\n\nPSG: This sleep study evaluates sleep structure, confirms sleep apnea, and rules out other sleep disorders.\n\nMSLT: This test measures the brain's tendency to fall asleep during the day. Additional Home-Based Sleep Studies: Participants will undergo two more PSG studies in their homes.\n\nEEG Monitoring: After the initial assessments, participants will have a small EEG electrode implanted to monitor brain activity.\n\nThe implant, a CE-certified device called 24\u002F7 EEG™ SubQ, will be inserted under local anesthesia by an experienced surgeon.\n\nOnce post-surgery swelling subsides (after about 7-10 days), continuous EEG monitoring will begin, where participants connect an external data storage device during the day. The device records for 12 weeks, and CPAP treatment begins around the 6-week mark.\n\nAfter 12 weeks, the EEG device is removed, and the study ends. Aditional Data Collection (Optional)\n\nDuring the 12 weeks of EEG recording, participants are asked to report:\n\nSleep Diary: Log daytime sleep episodes, including planned naps and unintended naps.\n\nQuestionnaires and Tests: Complete daily questionnaires about fatigue symptoms and perform a brief attention and reaction test. These tasks take 3-10 minutes each day and are accessible via smartphone or tablet.\n\nInterviews and Movement Tracking: Participants may also be invited to interviews on how sleepiness affects their daily life and asked to wear a motion-tracking watch to monitor activity.",[132,29],[172,173,174,136],"Excessive daytime sleepiness","Ultra long-term EEG","Obstructive Sleep Apnea","2024-11-25",{"date":177,"type":47},"2024-12-02",{"date":179,"type":47},"2024-10-11",{"date":181,"type":22},"2025-12-31",{"name":183,"class":54},"Zealand University Hospital"]