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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Sleep Navigator
BehavioralSleep Navigator will provide education, troubleshooting, motivation, and support pertaining to any additional questions or concerns regarding OSA. They will consult closely with the board-certified sleep medicine physician to ensure that participant care needs are met.
Treatment groups
Trial outcomes
Primary outcomes
Apnea-Hypopnea Index (AHI): Assesses OSA severity via events/hour from diagnostic testing.
Unit: Events/hour Scale: Continuous; higher values = more severe outcome
Oxygen Desaturation Metrics: Reports oxygen nadir (%) and % of sleep time with saturation <90%.
Units: Nadir (%), Time \<90% (% of total sleep time) Scale: Continuous; lower nadir = worse outcome, higher time \<90% = worse outcome
Positive Airway Pressure (PAP) Adherence
Includes treatment start date and usage (hours/night, % nights/week). Units: Start date; usage = hours/night, % nights/week Scale: Hours/night (min 0), % nights/week (0-100%); higher values = better outcome
PSQI: Pittsburgh Sleep Quality Index
Assesses sleep quality (0-21); higher = poorer sleep. Scale: 0 - no difficulty and 21 indicating severe difficulties
Sponsors and contacts
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Uniformed Services University of the Health Sciences
Lead sponsor
University of Maryland, Baltimore
Collaborator