Telehealth care with a human sleep navigator for obstructive sleep apnea in the military health system

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Walter Reed National Military Medical Center
  Bethesda, Maryland, United States Recruiting
• Uniformed Services University
  Bethesda, Maryland, United States Not yet 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• F&P Mask usability in home PAP/NIV care for adults with chronic breathing conditions

  This study tests how well the F&P Licorice Mask works at home for adults who already use PAP or NIV therapy.

  Recruiting Fisher and Paykel Healthcare · St Louis, Missouri · NCT07826429

• Sleep apnea biomarkers and CPAP use after diagnosis

  This study tests whether biomarkers from a diagnostic sleep study can predict how well adults with newly diagnosed obstructive sleep apnea will stick to CPAP therapy after about 3 months.

  Recruiting Clinique du Millenaire · Montpellier · NCT07792746

• Using the PLATO Questionnaire in Oral Appliance Therapy for Obstructive Sleep Apnea

  This real-world study tests whether the PLATO questionnaire can be feasibly used in dental sleep clinics for patients receiving oral appliance therapy for obstructive sleep apnea.

  Recruiting Nevada Dental Sleep · Henderson, Nevada · NCT07789834

• Managing COMISA: adding daridorexant to CPAP may help sleep and CPAP use

  This study tests whether adding daridorexant to CPAP helps people with COMISA better stick with CPAP and feel better.

  Recruiting University Hospital, Grenoble · Grenoble and 4 other locations · NCT07743931

• OSA Screening in Diverse Populations

  This study tests how common obstructive sleep apnea is across community members and people with certain diseases in China, using screening questionnaires and polysomnography or portable sleep monitors.

  Recruiting Guangzhou Institute of Respiratory Disease · Guangzhou, Guangdong and 1 other locations · NCT07736872

• Wall Squat Exercise to Help Lower Blood Pressure in Adults with Hypertension and Sleep Apnea

  This study tests whether doing an isometric wall squat can lower blood pressure in adults who have high blood pressure and sleep apnea treated with CPAP.

  Recruiting Aveiro University · Braga · NCT07730879

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.