Actively Recruiting
Telehealth for Sleep Apnea: Effectiveness, Implementation, and Cost in the Military Health System
Led by Uniformed Services University of the Health Sciences · Updated on 2025-11-10
160
Participants Needed
2
Research Sites
141 weeks
Total Duration
On this page
Sponsors
U
Uniformed Services University of the Health Sciences
Lead Sponsor
U
University of Maryland, Baltimore
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Telehealth for Sleep Apnea: Effectiveness, Implementation, and Cost in the Military Health System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-64 years
- Beneficiary of ADFM or DEERS
- Enrolled in any TRICARE plan (Prime, Standard, or Extra)
- Receiving OSA care through private sector (local TRICARE network)
- Newly diagnosed with OSA (Apnea-Hypopnea Index >5)
- Access to a smartphone, desktop, laptop, or tablet computer
You will not qualify if you...
- History of prior OSA testing, diagnosis, or care
- Contraindication for home sleep apnea testing per established criteria
- History of or high risk for sleep disorders other than OSA (e.g., REM behavior disorder, obesity hypoventilation syndrome)
- Active alcohol or substance dependence
- Severe sleepiness (Epworth Sleepiness Scale >18 or as judged by clinician)
- Pending permanent family change of station within 6 months
- Active-duty military service members
- Untreated major medical or psychiatric illness
- Pursuit of non-PAP treatment for OSA
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Uniformed Services University
Bethesda, Maryland, United States, 20814
Not Yet Recruiting
2
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20814
Actively Recruiting
Research Team
P
Pewu J Lavela, B.S
CONTACT
M
Manisha K Djohi, M.S.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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