Telehealth for Sleep Apnea: Effectiveness, Implementation, and Cost in the Military Health System

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
Uniformed Services University of the Health Sciences
Study ID
NCT07121452
Status
Recruiting
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Conditions

  • Obstructive Sleep Apnea (OSA)

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Sleep Navigator — BEHAVIORAL
    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.

Study Details

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). 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.

Key Dates

Start date
Oct 15, 2025
Status verified
Jul 2025
Primary completion
Jan 31, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Apnea-Hypopnea Index (AHI): Assesses OSA severity via events/hour from diagnostic testing. [ Time Frame: Participants are actively involved in the study for at least 90 days (approximately 3 months) following the initiation of PAP therapy. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Uniformed Services UniversityBethesdaMaryland20814
Pewu J Lavela, B.S
[email protected]
301-319-4930
Manisha K Djohi, M.S.
[email protected]
Vincent F Capaldi II, M.D (PRINCIPAL_INVESTIGATOR)
Walter Reed National Military Medical CenterBethesdaMaryland20814
Eungjae Kim, MD, MHPE
[email protected]
214-603-3577

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Uniformed Services University· Bethesda, MDWalter Reed National Military Medical Center· Bethesda, MD

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