[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100376320":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":61,"collaborators":26,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":26,"eligibilityCriteria":68,"healthyVolunteers":65,"sex":69,"minAge":70,"maxAge":26,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":88,"overallStatus":42,"whyStopped":26,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"VA Office of Research and Development","FED",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Conservative care (control arm)","OTHER","Eligible OVS patients will receive conservative care\u002Fusual care with education about sleep apnea and sleep hygiene via handouts and video instructions. This is the control arm.",[13],"Other: Conservative care (control arm)",{"label":15,"type":16,"description":17,"interventionNames":18},"PAP therapy arm","ACTIVE_COMPARATOR","PAP Therapy will be provided to eligible patients with OVS. This is the active therapy arm.",[19],"Device: Positive airway pressure",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Positive airway pressure","Positive airway pressure therapy. OVS patients randomized to PAP therapy arm will be titrated to optimal PAP therapy per standard protocol and assigned to use PAP therapy.",[15],null,{"type":10,"name":9,"description":11,"armGroupLabels":28,"otherNames":26},[9],[30],{"name":31,"affiliation":32,"role":33},"Susmita Chowdhuri, MD MS","John D. Dingell VA Medical Center, Detroit, MI","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":26,"email":39},"Ruchi Rastogi, MS","CONTACT","(313) 576-4464","ruchi.rastogi@va.gov",[41],{"facility":32,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Detroit","Michigan","48201-1916","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-83.04575,42.33143,{"lat":52,"lon":51},[55,56,60],{"name":36,"role":37,"phone":38,"phoneExt":26,"email":39},{"name":57,"role":37,"phone":58,"phoneExt":26,"email":59},"Edi Levi, MD","(313) 576-4451","edi.levi@va.gov",{"name":31,"role":33,"phone":26,"phoneExt":26,"email":26},{"type":62,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100376320","impact-of-positive-airway-pressure-therapy-on-clinical-outcomes-in-older-veterans-with-chronic-obstructive-pulmonary-disease-and-comorbid-obstructive-sleep-apnea-overlap-syndrome-100376320",false,"NCT04179981","Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older Veterans With Chronic Obstructive Pulmonary Disease and Comorbid Obstructive Sleep Apnea (Overlap Syndrome)","Inclusion Criteria:\n\n* OSA with moderate-to-severe disease, AHI 20 per hour by in-lab polysomnography with concomitant moderate-severe COPD based on pulmonary function tests (PFTS) and with past significant history (\\>10 pack-years) of smoking\n* Male or female gender\n* Age greater than or equal to 60 years\n* Stable treatment regimen for COPD\n\nExclusion Criteria:\n\n* Current or prior treatment with PAP or oral appliance\n* Central sleep apnea defined as central apnea index \\>5 per hour and comprising 50% of AHI\n* Known primary neuromuscular diseases\n* Disorders that may impact cognitive function including:\n\n  * neurodegenerative disorders\n  * traumatic brain injury\n* untreated PTSD and\u002For history of learning disability\n* Medicines that may cause or alter sleepiness: sedative hypnotics, or stimulants as these may alter the results\n* Patient is actively suicidal due to depression, unstable mental health condition\n* Epworth sleepiness score \\>16 (severe sleepiness) or a near-miss or prior automobile accident due to sleepiness within the past 12 months\n* Narcolepsy is the primary sleep disorder, with requirement of stimulant medications\n* Employed as a commercial driver or operating heavy machinery\n* On long-term oxygen therapy prior to start of study, more than 12 hr\u002Fday\n* Patients is unable to use either a nasal or face mask (e.g., facial trauma, claustrophobia)\n* Consumption of \\>3 alcoholic beverages per day or current use of some illicit drugs, as these may contribute to cognitive deficits\n* Patients who cannot give informed consent\n* Patients receiving hospice care\n* Pregnant women due to unknown risks","ALL","60 Years",{"count":72,"type":73},668,"ESTIMATED","INTERVENTIONAL",[76],"NA","Obstructive sleep apnea (OSA) and Chronic Obstructive Pulmonary Disease (COPD) are highly prevalent chronic respiratory diseases in the Veteran population. OSA co-occurring with COPD, known as Overlap Syndrome (OVS), is a complex chronic medical condition associated with grave consequences. OVS is highly prevalent in Veterans. Veterans with OVS may be at increased risk for cognitive deficits, poor sleep quality as well as a reduced quality of life (QoL). The overall objective is to study the effects of positive airway pressure therapy on clinical outcomes in patients with OVS.",[79,80,81,82,83,84,85,86,87],"Sleep Apnea Syndrome","Obstructive Sleep Apnea","COPD","Overlap Syndrome","Quality of Life","Neurocognitive Function","Sleepiness","Elderly","Positive Airway Pressure",[89,90,91,92,93,94,95,96,97,98,99],"Apnea","Sleep Apnea Syndromes","Sleep Apnea, Obstructive","Nervous System Diseases","Respiration Disorders","Respiratory Tract Diseases","Signs and Symptoms, Respiratory","positive airway pressure","cognitive function","quality of life","sleepiness","2026-06-03",{"date":102,"type":103},"2026-06-05","ACTUAL",{"date":105,"type":103},"2020-12-01",{"date":107,"type":73},"2027-12-31",{"name":5,"class":6},1]