TELE-SLEEP OSA: A protocol for a hybrid type I randomized clinical trial of telemedicine for obstructive sleep apnea among military dependents and retirees

Background: Obstructive sleep apnea (OSA) is common and costly in the U.S. military health system (MHS). OSA is associated with poor health outcomes as well as increased economic burden borne by the Defense Health Agency. The MHS lacks the capacity to meet the available demand for sleep specialty care. Thus, most military OSA care is provided by private sector TRICARE-contracted civilian providers. Given the burden of OSA and limited access to OSA care, optimizing OSA care within the MHS is vital. TELE-SLEEP OSA is a randomized, parallel group, single blind, controlled clinical trial comparing OSA telehealth care to standard private sector TRICARE. Methods: Participants will include 160 active-duty family members and Defense Enrollment Eligibility Reporting System beneficiaries who are referred for OSA consultation. Following informed consent, participants will complete baseline assessments prior to randomization. Participants randomized to private sector TRICARE will receive treatment as usual, including positive airway pressure (PAP) therapy. Participants randomized to OSA telehealth care will undergo telehealth consultation with a board-certified sleep medicine specialist, undergo home sleep apnea testing, receive auto-titrating PAP therapy, and receive ongoing support from educator-level sleep navigators throughout the study. Quantitative follow-up assessments will be completed at 30 and 90 days after treatment initiation. Qualitative focus groups to assess participant satisfaction and other implementation outcomes will be conducted with participants from both treatment groups. Outcomes include PAP adherence (primary outcome), OSA symptoms, implementation, and cost-effectiveness. Conclusion: Our telemedicine approach to OSA treatment aims to reduce costs and improve health outcomes within the MHS. Clinical trial registration: NCT07121452.