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

NCT07121452 | Recruiting

• 2 other identifiers: USUHS.2024-142HT94252410479
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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)

Keywords

sleep; sleep apnea; treatment; telehealth; implementation

Outcome Measures

Primary Outcomes (14)

• Apnea-Hypopnea Index (AHI): Assesses OSA severity via events/hour from diagnostic testing.

  Unit: Events/hour Scale: Continuous; higher values = more severe outcome

  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%.

  Units: Nadir (%), Time \<90% (% of total sleep time) Scale: Continuous; lower nadir = worse outcome, higher time \<90% = worse outcome

  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

  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

  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

  Assesses sleep quality (0-21); higher = poorer sleep. Scale: 0 - no difficulty and 21 indicating severe difficulties

  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

  Rates insomnia severity (0-28); higher = worse. Scale: 15-21 moderate insomnia, 22-28 severe insomnia.

  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

  Assesses daytime sleepiness (0-24); higher = worse. Scale: 11-12 mild, 13-15 moderate, 16-24 excessive sleepiness.

  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

  Evaluates OSA-related functional impact; higher scores = better functioning. Scale: 4 - no difficulty, 3 - yes, a little difficulty, 2 - yes, moderate difficulty, 1 - yes, extreme difficulty.

  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

  Evaluates general health-related quality of life. Scale: The scoring yields two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Interpretation of Scores: Norm-based scoring system will be used to interpret PCS and MCS scores, with a mean of 50 and a standard deviation of 10 in the general population. Scores above 50 indicate a better-than-average health-while scores below 50 suggest below-average health.

  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

  PHQ-8: Measures depressive symptoms (0-24); higher = worse. Scale: 0-4 no significant depression, 5-9 mild depressive symptoms, 10-14 moderate depressive symptoms, 15-19 moderately severe depressive symptoms, 20-24 severe depressive symptoms.

  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

  Evaluates anxiety symptoms (0-21); higher = worse anxiety severity. Scale: 0-4 minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, 15-21 severe anxiety

  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

  Evaluates trauma symptoms. Scale: 0-20 minimal symptoms, 21-40 mild symptoms, 41-60 moderate symptoms, 61-80 severe symptoms.

  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

  Measures impairment in work/daily activities. Determines impact in percentages on absenteeism, presenteeism, overall work impairment, and activity impairment. higher %= greater impact. Scale: (0-100%), Higher scores indicate greater impairment and less productivity

  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

  Modified questionnaire to measure patient satisfaction. Formative evaluation

  Participants are actively involved in the study for at least 90 days (approximately 3 months) following the initiation of PAP therapy.

• Health Care Utilization

  Measures quantity healthcare services including dates and types of encounters, OSA diagnostic testing, and provision of PAP machines and supplies.

  Participants are actively involved in the study for at least 90 days (approximately 3 months) following the initiation of PAP therapy.

Study Arms (2)

OSA telehealth care

EXPERIMENTAL

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 \[CCSH\]).

Behavioral: Sleep Navigator

Private Sector Care

NO INTERVENTION

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 BEHAVIORAL

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.

Also known as: MedBridge

OSA telehealth care

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Newly diagnosed with OSA (AHI\>5)
• Access to smartphone, desktop, laptop, or tablet computer

You may not qualify if:

• 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
• Severe sleepiness (Epworth Sleepiness Scale \[ESS\]\>18, or clinician judgment)
• Pending permanent family change of station (PCS) within 6 months
• Active-duty military service members (ADSM)
• Untreated major medical or psychiatric illness
• Pursuit of non-PAP treatment for OSA

Sponsors & Collaborators

• Uniformed Services University of the Health Sciences: lead
• University of Maryland, Baltimore: collaborator

Study Sites (2)

Uniformed Services University

Bethesda, Maryland, 20814, United States

NOT YET RECRUITING

Walter Reed National Military Medical Center

Bethesda, Maryland, 20814, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Vincent F Capaldi II, M.D

  Uniformed Services University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pewu J Lavela, B.S

CONTACT

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

Manisha K Djohi, M.S.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: August 13, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: November 10, 2025

Record last verified: 2025-07

Locations

US (2)