Tele-Sleep OSA: Clinical Effectiveness, Implementation, and Economic Impact of Telehealth Care for Obstructive Sleep Apnea in the Military Health System
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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). Hypothesis 1b: Relative to private sector care, OSA telehealth care is non-inferior for reducing OSA symptoms and for patient satisfaction (secondary endpoints). Specific 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. Specific Aim 3: To perform a cost-effectiveness analysis of OSA telehealth care from the DHA perspective. Hypothesis 3: Relative to private sector care, OSA telehealth care is more cost-effective.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: f
View:
• Age 18-64 years
• ADFM or DEERS beneficiary
• Enrolled in any TRICARE (Prime, Standard, or Extra)
• Deferred to private sector care (i.e., local TRICARE network) for OSA care
• Newly diagnosed with OSA (AHI\>5)
• Access to smartphone, desktop, laptop, or tablet computer
Locations
United States
Maryland
Uniformed Services University
NOT_YET_RECRUITING
Bethesda
Walter Reed National Military Medical Center
RECRUITING
Bethesda
Contact Information
Primary
Pewu J Lavela, B.S
pewu.lavela.ctr@usuhs.edu
301-319-4930
Backup
Manisha K Djohi, M.S.
manisha.djohi.ctr@usuhs.edu
301-319-4930
Time Frame
Start Date:2025-10-15
Estimated Completion Date:2028-06-30
Participants
Target number of participants:160
Treatments
Experimental: OSA telehealth care
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 \[CCSH\]).
No_intervention: Private Sector Care
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.