EICHORCondition: Obstructive Sleep Apnea (OSA) · Sponsor: Uniformed Services University of the Health Sciences
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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. Sp…
This description comes directly from the study's public registry record.
Pewu J Lavela, B.S · 301-319-4930 · pewu.lavela.ctr@usuhs.edu
Manisha K Djohi, M.S. · 301-319-4930 · manisha.djohi.ctr@usuhs.edu
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Inclusion Criteria: 1. Age 18-64 years 2. ADFM or DEERS beneficiary 3. Enrolled in any TRICARE (Prime, Standard, or Extra) 4. Deferred to private sector care (i.e., local TRICARE network) for OSA care 5. Newly diagnosed with OSA (AHI\>5) 6. Access to smartphone, desktop, laptop, or tablet computer Exclusion Criteria: 1. History of prior OSA testing, diagnosis, or care 2. Contraindication for home sleep apnea testing, based on established AASM criteria 3. History of or high-risk for organic sleep disorders other than OSA (e.g., REM behavior disorder, obesity hypoventilation syndrome) 4. Active alcohol or substance dependence 5. Severe sleepiness (Epworth Sleepiness Scale \[ESS\]\>18, or clinician judgment) 6. Pending permanent family change of station (PCS) within 6 months 7. Active-duty military service members (ADSM) 8. Untreated major medical or psychiatric illness 9. Pursuit of non-PAP treatment for OSA
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Uniformed Services University | Bethesda, Maryland, United States | Not Yet Recruiting |
| Walter Reed National Military Medical Center | Bethesda, Maryland, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07121452