[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04538755":3,"trial-entities:NCT04538755":87,"trial-summary:NCT04538755":91},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":26,"interventions":29,"primary_outcomes":41,"secondary_outcomes":46,"sex":47,"minimum_age":48,"maximum_age":49,"healthy_volunteers":50,"eligibility_criteria":51,"std_ages":67,"locations":70,"central_contacts":79,"overall_officials":80,"references":81,"see_also_links":86},"NCT04538755","2020p002760-1","DAW2020 on OSA Endotypic Traits","Effect of DAW2020 on Endotypic Traits in OSA","ENROLLING_BY_INVITATION","2026-12-15","2026-07","2026-07-15","2020-11-15","Brigham and Women's Hospital","OTHER",true,"Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. Some OSA patients with low arousal threshold wake up prematurely during an obstructive event and do not have time for spontaneous upper airway (UA) dilator muscle recruitment. As a consequence they are exposed to apnea and hypopnea cycling. In this protocol the investigators will test the effect of DAW2020 administered before sleep on OSA phenotype traits and OSA severity during sleep.","Two overnight sleep studies will be performed: a drug night and a placebo night. The patient will breath spontaneously (without CPAP) for both nights. On the study nights, subjects will present to the laboratory in the evening and be instrumented with a full polysomnigraphy for monitoring sleep, physiological variables (endotypes), and respiratory events. A history and physical examination will be performed on each night prior to beginning the study, as will a urine pregnancy test in premenopausal women. DAW2020 34 mg will be given 4 hours before lights out. Subjects will sleep at least 50% of the night in the supine position. At least four hours of sleep with high quality signal acquisition will be required for a study to be judged adequate. After the first overnight study is completed, there will be a one-week washout period prior to crossing over to the other treatment.",[19],"Obstructive Sleep Apnea (OSA)",[],"INTERVENTIONAL","TREATMENT",[24,25],"PHASE1","PHASE2",{"count":27,"type":28},20,"ESTIMATED",[30,36],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","Placebo oral capsule","Placebo before sleep",[35],"Placebo",{"type":31,"name":37,"description":38,"armGroupLabels":39},"DAW2020 oral capsule","DAW2020 34 mg 4 h before sleep, single night administration",[40],"DAW2020",[42],{"measure":43,"description":44,"timeFrame":45},"Effects of DAW2020 on arousal threshold (%eupnea)","Arousal threshold will be calculated using diaphragm EMG","1 night",[],"ALL","21 Years","70 Years",false,{"inclusion":52,"exclusion":54,"raw_text":66},[53],"Moderate-to-severe OSA (AHI ≥ 15 events\u002Fhr)",[55,56,57,58,59,60,61,62,63,64,65],"All participants will be healthy and without major organ system disease that would preclude undergoing the physiological measurements.","Use of medications expected to stimulate or depress respiration (including opioids, barbiturates, acetazolamide, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid).","Use of SNRIs\u002FSSRIs.","Conditions likely to affect OSA physiology: neuromuscular disease or other major neurological disorder, heart failure (also below), or any other unstable major medical condition.","Sleep disordered breathing or respiratory disorders other than obstructive sleep apnea:","Other sleep disorders: periodic limb movements (periodic limb movement arousal index \\> 10\u002Fhr), narcolepsy, or parasomnias.","Hypersensitivity to the study drug (angioedema or urticaria)","Contraindications to DAW2020","Use of medications that lengthen QTc interval","Hypokaliemia, hypomagnesemia, uncontrolled thyroid disease","Severe claustrophobia.","Inclusion Criteria:\n\n* Moderate-to-severe OSA (AHI ≥ 15 events\u002Fhr)\n\nExclusion Criteria:\n\n* All participants will be healthy and without major organ system disease that would preclude undergoing the physiological measurements.\n* Use of medications expected to stimulate or depress respiration (including opioids, barbiturates, acetazolamide, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid).\n* Use of SNRIs\u002FSSRIs.\n* Conditions likely to affect OSA physiology: neuromuscular disease or other major neurological disorder, heart failure (also below), or any other unstable major medical condition.\n* Sleep disordered breathing or respiratory disorders other than obstructive sleep apnea:\n* Other sleep disorders: periodic limb movements (periodic limb movement arousal index \\> 10\u002Fhr), narcolepsy, or parasomnias.\n* Hypersensitivity to the study drug (angioedema or urticaria)\n* Contraindications to DAW2020\n* Use of medications that lengthen QTc interval\n* Hypokaliemia, hypomagnesemia, uncontrolled thyroid disease\n* Severe claustrophobia.",[68,69],"ADULT","OLDER_ADULT",[71],{"facility":13,"city":72,"state":73,"zip":74,"country":75,"geoPoint":76},"Boston","Massachusetts","02115","United States",{"lat":77,"lon":78},42.35843,-71.05977,[],[],[82],{"pmid":83,"type":84,"citation":85},"35947827","DERIVED","Messineo L, Gell L, Calianese N, Sofer T, Vena D, Azarbarzin A, Labarca G, Taranto-Montemurro L, Yang HC, Wang TY, Kim M, Smith H, White D, Sands S, Wellman A. Effect of Pimavanserin on the Respiratory Arousal Threshold from Sleep: A Randomized Trial. Ann Am Thorac Soc. 2022 Dec;19(12):2062-2069. doi: 10.1513\u002FAnnalsATS.202205-419OC.",[],{"nct_id":4,"conditions":88,"biomarkers":90},[89],"Obstructive Sleep Apnea",[],{"nct_id":4,"found":15,"summary":92,"prompt_version":102},{"design":93,"status":94,"heading":95,"summary":96,"follow_up":97,"word_count":98,"commitments":99,"compensation":100,"drugs_mentioned":101},"This is an interventional study with 20 participants, comparing DAW2020 to a placebo (an inactive capsule). It involves two overnight sleep studies.","completed","DAW2020 for Obstructive Sleep Apnea (OSA) Endotypic Traits","This study is looking at how DAW2020, an oral capsule, affects Obstructive Sleep Apnea (OSA) in people aged 21 to 70. OSA is a common condition where breathing repeatedly stops and starts during sleep. Researchers want to see if DAW2020 can help with a specific OSA trait called \"arousal threshold,\" which is how easily someone wakes up during a breathing problem. You could be eligible if you have moderate-to-severe OSA (meaning you have at least 15 breathing interruptions per hour) and are generally healthy. The study is currently unclear on its recruitment status and plans to enroll 20 participants.","The primary effect of DAW2020 is measured after one night of treatment.",99,"You would have two overnight stays at a sleep lab, where you'll be monitored for sleep and breathing. There will be a one-week break between the two overnight stays.","Not stated in the trial record.",[],"v2"]