Telehealth care with a human sleep navigator for obstructive sleep apnea 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
This study will test whether telehealth OSA care that includes a human sleep navigator works as well and costs less than private-sector care for TRICARE beneficiaries newly diagnosed with obstructive sleep apnea.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Uniformed Services University of the Health Sciences Federal |
| Locations | 2 sites (Bethesda, Maryland and 1 other locations) |
| Trial ID | NCT07121452 on ClinicalTrials.gov |
What this trial studies
The program compares telehealth-delivered OSA care that pairs patients with a human sleep navigator against usual private-sector care for TRICARE beneficiaries newly diagnosed with OSA. Participants who meet eligibility will be assigned to telehealth care or to receive care in the private sector, and clinical outcomes, adherence, and costs will be tracked over time to determine non-inferiority and cost-effectiveness. Investigators will also perform a formative implementation evaluation within the National Capital Region to document barriers, facilitators, and process measures. Results will combine clinical, economic, and implementation data to inform scalability across the Military Health System.
Who should consider this trial
Good fit: Ideal candidates are TRICARE-enrolled adults aged 18–64 who are newly diagnosed with OSA (AHI > 5), have not had prior OSA testing or treatment, and have access to a smartphone or computer.
Not a fit: Patients unlikely to benefit include active-duty service members, people with prior OSA care, those with severe sleepiness (ESS > 18) or other high-risk sleep disorders, untreated major medical or psychiatric illness, active substance dependence, or those planning a permanent move within six months.
Why it matters
Potential benefit: If successful, this approach could maintain clinical outcomes while improving access and lowering costs for military beneficiaries with OSA, supporting readiness.
How similar studies have performed: Previous civilian studies of telehealth and remote PAP support have shown comparable adherence and symptom outcomes to in-person care, but combining a dedicated human sleep navigator within the Military Health System is less well-studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18-64 years 2. ADFM or DEERS beneficiary 3. Enrolled in any TRICARE (Prime, Standard, or Extra) 4. Deferred to private sector care (i.e., local TRICARE network) for OSA care 5. Newly diagnosed with OSA (AHI\>5) 6. Access to smartphone, desktop, laptop, or tablet computer Exclusion Criteria: 1. History of prior OSA testing, diagnosis, or care 2. Contraindication for home sleep apnea testing, based on established AASM criteria 3. History of or high-risk for organic sleep disorders other than OSA (e.g., REM behavior disorder, obesity hypoventilation syndrome) 4. Active alcohol or substance dependence 5. Severe sleepiness (Epworth Sleepiness Scale \[ESS\]\>18, or clinician judgment) 6. Pending permanent family change of station (PCS) within 6 months 7. Active-duty military service members (ADSM) 8. Untreated major medical or psychiatric illness 9. Pursuit of non-PAP treatment for OSA
Where this trial is running
Bethesda, Maryland and 1 other locations
- Uniformed Services University — Bethesda, Maryland, United States (Not_yet_recruiting)
- Walter Reed National Military Medical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Vincent F Capaldi II, M.D — Uniformed Services University Health Sciences
- Study coordinator: Pewu J Lavela, B.S
- Email: pewu.lavela.ctr@usuhs.edu
- Phone: 301-319-4930
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.