Recruiting

OSA Telehealth Care

Sponsor:

Uniformed Services University of the Health Sciences

Code:

NCT07121452

Conditions

Obstructive Sleep Apnea (OSA)

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Sleep Navigator

Study Details

Brief summary:

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.

Conditions

Obstructive Sleep Apnea (OSA)

Study ID

NCT07121452

Start date

Oct 15, 2025

Status verified date

Jul, 2025

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: OSA telehealth care

Participants randomized to OSA telehealth care will undergo OSA clinical evaluation via secure video conferencing platform; complete diagnostic OSA testing via established home sleep apnea test (HSAT) procedures; receive comprehensive sleep education; and when indicated, initiate PAP therapy via auto-titrating PAP (APAP). The initial consultation and treatment planning visit will take place with a board-certified sleep medicine physician. Ongoing participant education and support will take place via a secure video conferencing platform with a human sleep navigator (likely a certified clinical sleep health educator \[CCSH\]).

no intervention: Private Sector Care

Participants randomized to private sector care will complete outcomes assessments (i.e., self-report questionnaires) with trained study staff and will undergo treatment as usual.

Interventions

Sleep Navigator

Sleep 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.

Primary outcome measure

  • Apnea-Hypopnea Index (AHI): Assesses OSA severity via events/hour from diagnostic testing. [ Time Frame: Participants are actively involved in the study for at least 90 days (approximately 3 months) following the initiation of PAP therapy. ]
  • Oxygen Desaturation Metrics: Reports oxygen nadir (%) and % of sleep time with saturation <90%. [ Time Frame: Participants are actively involved in the study for at least 90 days (approximately 3 months) following the initiation of PAP therapy ]
  • Positive Airway Pressure (PAP) Adherence [ Time Frame: Participants are actively involved in the study for at least 90 days (approximately 3 months) following the initiation of PAP therapy. ]
  • PSQI: Pittsburgh Sleep Quality Index [ Time Frame: Participants are actively involved in the study for at least 90 days (approximately 3 months) following the initiation of PAP therapy ]
  • ISI: Insomnia Severity Index [ Time Frame: Participants are actively involved in the study for at least 90 days (approximately 3 months) following the initiation of PAP therapy ]
  • ESS - Epworth Sleepiness Scale [ Time Frame: Participants are actively involved in the study for at least 90 days (approximately 3 months) following the initiation of PAP therapy ]
  • FOSQ: Functional Outcomes of Sleep Questionnaire [ Time Frame: Participants are actively involved in the study for at least 90 days (approximately 3 months) following the initiation of PAP therapy ]
  • SF-12 - Short-form 12 [ Time Frame: Participants are actively involved in the study for at least 90 days (approximately 3 months) following the initiation of PAP therapy. ]
  • PHQ-8 - Patient Health Questionnaire 8 [ Time Frame: Participants are actively involved in the study for at least 90 days (approximately 3 months) following the initiation of PAP therapy. ]
  • GAD-7: Generalized Anxiety Disorder - 7 [ Time Frame: Participants are actively involved in the study for at least 90 days (approximately 3 months) following the initiation of PAP therapy ]
  • PCL-5 - PTSD Checklist for DSM-5 [ Time Frame: Participants are actively involved in the study for at least 90 days (approximately 3 months) following the initiation of PAP therapy. ]
  • WPAI: Work Productivity and Activity Impairment Questionnaire [ Time Frame: Participants are actively involved in the study for at least 90 days (approximately 3 months) following the initiation of PAP therapy ]
  • RE-AIM: Reach, Effectiveness, Adoption, Implementation, Maintenance [ Time Frame: Participants are actively involved in the study for at least 90 days (approximately 3 months) following the initiation of PAP therapy. ]
  • Health Care Utilization [ Time Frame: Participants are actively involved in the study for at least 90 days (approximately 3 months) following the initiation of PAP therapy. ]

Central Contacts and Locations

Central contacts

Pewu J Lavela, B.S

301-319-4930pewu.lavela.ctr@usuhs.edu

Manisha K Djohi, M.S.

301-319-4930manisha.djohi.ctr@usuhs.edu

Locations

Walter Reed National Military Medical Center

Recruiting

Bethesda, Maryland, United States, 20814

Contacts

Eungjae Kim, MD, MHPE

214-603-3577eungjae.kim@usuhs.edu

More Information

Sponsor

Uniformed Services University of the Health Sciences

Last update posted

Nov 10, 2025

Last verified

Jul, 2025

Keywords

  • sleep
  • sleep apnea
  • treatment
  • telehealth
  • implementation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Uniformed Services University of the Health Sciences on 2025-11-10.