๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-11-05

Telehealth for Sleep Apnea: Effectiveness, Implementation, and Cost in the Military Health System (NCT07121452)

Tele-Sleep OSA: Clinical Effectiveness, Implementation, and Economic Impact of Telehealth Care for Obstructive Sleep Apnea in the Military Health System

๐ŸŸข Recruiting Observational / Diagnostic ๐Ÿง  Behavioral & Psychological Program Sponsor: Uniformed Services University of the Health Sciences

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Uniformed Services University โ€” Bethesda, Maryland

Age range: 18 Years to 64 Years

๐Ÿงช Interventions in This Study

  • Sleep Navigator (BEHAVIORAL)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (2 Sites)

  • Uniformed Services University โ€” Bethesda, Maryland
  • Walter Reed National Military Medical Center โ€” Bethesda, Maryland

๐Ÿ“ž Contact the Study Coordinator

Phone: (301) 319-4930

Email: pewu.lavela.ctr@usuhs.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—