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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorUniformed Services University of the Health Sciences

About this trial

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.

Eligibility criteria

Qualifiers

Age 18-64 years

ADFM or DEERS beneficiary

Enrolled in any TRICARE (Prime, Standard, or Extra)

Deferred to private sector care (i.e., local TRICARE network) for OSA care

Disqualifiers

History of prior OSA testing, diagnosis, or care

Contraindication for home sleep apnea testing, based on established AASM criteria

History of or high-risk for organic sleep disorders other than OSA (e.g., REM behavior disorder, obesity hypoventilation syndrome)

Active alcohol or substance dependence

Trial design

Treatments tested in this trial

  • Sleep Navigator

Treatment groups

160 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Uniformed Services University of the Health Sciences

Lead sponsor

University of Maryland, Baltimore

Collaborator