[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602280":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":41,"responsibleParty":71,"collaborators":73,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":18,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":62,"whyStopped":18,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Uniformed Services University of the Health Sciences","FED",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"OSA telehealth care","EXPERIMENTAL","Participants randomized to OSA telehealth care will undergo OSA clinical evaluation via secure video conferencing platform; complete diagnostic OSA testing via established home sleep apnea test (HSAT) procedures; receive comprehensive sleep education; and when indicated, initiate PAP therapy via auto-titrating PAP (APAP). The initial consultation and treatment planning visit will take place with a board-certified sleep medicine physician. Ongoing participant education and support will take place via a secure video conferencing platform with a human sleep navigator (likely a certified clinical sleep health educator \\[CCSH\\]).",[13],"Behavioral: Sleep Navigator",{"label":15,"type":16,"description":17,"interventionNames":18},"Private Sector Care","NO_INTERVENTION","Participants randomized to private sector care will complete outcomes assessments (i.e., self-report questionnaires) with trained study staff and will undergo treatment as usual.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Sleep Navigator","Sleep Navigator will provide education, troubleshooting, motivation, and support pertaining to any additional questions or concerns regarding OSA. They will consult closely with the board-certified sleep medicine physician to ensure that participant care needs are met.",[9],[26],"MedBridge",[28],{"name":29,"affiliation":30,"role":31},"Vincent F Capaldi II, M.D","Uniformed Services University Health Sciences","PRINCIPAL_INVESTIGATOR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":18,"email":37},"Pewu J Lavela, B.S","CONTACT","301-319-4930","pewu.lavela.ctr@usuhs.edu",{"name":39,"role":35,"phone":36,"phoneExt":18,"email":40},"Manisha K Djohi, M.S.","manisha.djohi.ctr@usuhs.edu",[42,60],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Uniformed Services University","NOT_YET_RECRUITING","Bethesda","Maryland","20814","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-77.10026,38.98067,{"lat":54,"lon":53},[57,58,59],{"name":34,"role":35,"phone":36,"phoneExt":18,"email":37},{"name":39,"role":35,"phone":18,"phoneExt":18,"email":40},{"name":29,"role":31,"phone":18,"phoneExt":18,"email":18},{"facility":61,"status":62,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},"Walter Reed National Military Medical Center","RECRUITING",{"type":51,"coordinates":64},[53,54],{"lat":54,"lon":53},[67],{"name":68,"role":35,"phone":69,"phoneExt":18,"email":70},"Eungjae Kim, MD, MHPE","214-603-3577","eungjae.kim@usuhs.edu",{"type":72,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[74],{"name":75,"class":76},"University of Maryland, Baltimore","OTHER","100602280","telehealth-for-sleep-apnea-effectiveness-implementation-and-cost-in-the-military-health-system-100602280",false,"NCT07121452","Telehealth for Sleep Apnea: Effectiveness, Implementation, and Cost in the Military Health System","Tele-Sleep OSA: Clinical Effectiveness, Implementation, and Economic Impact of Telehealth Care for Obstructive Sleep Apnea in the Military Health System","TS OSA","Inclusion Criteria:\n\n1. Age 18-64 years\n2. ADFM or DEERS beneficiary\n3. Enrolled in any TRICARE (Prime, Standard, or Extra)\n4. Deferred to private sector care (i.e., local TRICARE network) for OSA care\n5. Newly diagnosed with OSA (AHI\\>5)\n6. Access to smartphone, desktop, laptop, or tablet computer\n\nExclusion Criteria:\n\n1. History of prior OSA testing, diagnosis, or care\n2. Contraindication for home sleep apnea testing, based on established AASM criteria\n3. History of or high-risk for organic sleep disorders other than OSA (e.g., REM behavior disorder, obesity hypoventilation syndrome)\n4. Active alcohol or substance dependence\n5. Severe sleepiness (Epworth Sleepiness Scale \\[ESS\\]\\>18, or clinician judgment)\n6. Pending permanent family change of station (PCS) within 6 months\n7. Active-duty military service members (ADSM)\n8. Untreated major medical or psychiatric illness\n9. Pursuit of non-PAP treatment for OSA","ALL","18 Years","64 Years",{"count":89,"type":90},160,"ESTIMATED","INTERVENTIONAL",[93],"NA","The long-term goal of this research is to improve military health and operational readiness among military service members with sleep disorders. The overall objective of the current study is to 1) determine the clinical effectiveness (non-inferiority) and cost-effectiveness of OSA telehealth care, including a human sleep navigator (vs private sector care), and 2) to perform a formative evaluation of the implementation of the OSA telehealth care intervention within the National Capitol Region (NCR) market. The central hypothesis is that OSA telehealth care including a human sleep navigator is clinically non-inferior to private sector care and also more cost-effective than private sector care. The investigators plan to achieve the objectives via these 3 Specific Aims: Specific Aim 1: To determine the clinical effectiveness (non-inferiority) of OSA telehealth care, relative to private sector care. Hypothesis 1a: Relative to private sector care, OSA telehealth care is non-inferior for achieving PAP adherence (primary endpoint).\n\nHypothesis 1b: Relative to private sector care, OSA telehealth care is non-inferior for reducing OSA symptoms and for patient satisfaction (secondary endpoints).\n\nSpecific Aim 2: To engage participants via qualitative focus groups and conduct a formative evaluation of the implementation of the OSA telehealth care intervention, using a standardized approach based on the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.\n\nSpecific Aim 3: To perform a cost-effectiveness analysis of OSA telehealth care from the DHA perspective.\n\nHypothesis 3: Relative to private sector care, OSA telehealth care is more cost-effective.",[96],"Obstructive Sleep Apnea (OSA)",[98,99,100,101,102],"sleep","sleep apnea","treatment","telehealth","implementation","2025-11-05",{"date":105,"type":106},"2025-11-10","ACTUAL",{"date":108,"type":106},"2025-10-15",{"date":110,"type":90},"2028-06-30",{"name":5,"class":6},2]