Actively Recruiting

Phase Not Applicable
Age: 18Years - 64Years
All Genders
NCT07121452

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

Age: 18Years - 64Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here