Telehealth for Sleep Apnea in the Military Health System

This study is looking at how well telehealth care, including support from a "Sleep Navigator," works for people with Obstructive Sleep Apnea (OSA) in the military health system. A Sleep Navigator is a person who provides education, helps with problems, and offers encouragement for your OSA care. This study wants to see if this telehealth approach is as effective and more cost-efficient than standard private sector care. You might be able to join if you are between 18 and 64 years old, a military beneficiary, and have been newly diagnosed with OSA. The study will measure how severe your sleep apnea is, your oxygen levels during sleep, and how well you use your Positive Airway Pressure (PAP) therapy over about 3 months.

Study design
This is an interventional study planning to enroll 160 participants. The study aims to compare telehealth care with private sector care for Obstructive Sleep Apnea.
What's involved
Participants will be actively involved in the study for at least 90 days (approximately 3 months) following the start of PAP therapy. The Sleep Navigator will provide education, troubleshooting, motivation, and support.
Compensation
Not stated in the trial record.
Follow-up
Participants are actively involved in the study for at least 90 days (approximately 3 months) following the initiation of PAP therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07121452

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

Recruiting
NAAges 18–64InterventionalTreatment
Uniformed Services University of the Health Sciences
~160 participants
Updated 2025-11-10 on ClinicalTrials.gov
What's tested:Sleep Navigator

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Apnea-Hypopnea Index (AHI): Assesses OSA severity via events/hour from diagnostic testing.
Measured over Participants are actively involved in the study for at least 90 days (approximately 3 months) following the initiation of PAP therapy.
+13 more outcomes measured
Obstructive Sleep Apnea (OSA)
2 sites across 1 states
Maryland2
  • Vincent F Capaldi II, M.D · PRINCIPAL_INVESTIGATOR · Uniformed Services University Health Sciences

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  • Apnea-Hypopnea Index (AHI): Assesses OSA severity via events/hour from diagnostic testing.Participants are actively involved in the study for at least 90 days (approximately 3 months) following the initiation of PAP therapy.

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

  • Oxygen Desaturation Metrics: Reports oxygen nadir (%) and % of sleep time with saturation <90%.Participants are actively involved in the study for at least 90 days (approximately 3 months) following the initiation of PAP therapy

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

  • Positive Airway Pressure (PAP) AdherenceParticipants are actively involved in the study for at least 90 days (approximately 3 months) following the initiation of PAP therapy.

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

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

  • ISI: Insomnia Severity IndexParticipants are actively involved in the study for at least 90 days (approximately 3 months) following the initiation of PAP therapy

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

  • ESS - Epworth Sleepiness ScaleParticipants are actively involved in the study for at least 90 days (approximately 3 months) following the initiation of PAP therapy

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

  • FOSQ: Functional Outcomes of Sleep QuestionnaireParticipants are actively involved in the study for at least 90 days (approximately 3 months) following the initiation of PAP therapy

    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.

  • SF-12 - Short-form 12Participants are actively involved in the study for at least 90 days (approximately 3 months) following the initiation of PAP therapy.

    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.

  • PHQ-8 - Patient Health Questionnaire 8Participants are actively involved in the study for at least 90 days (approximately 3 months) following the initiation of PAP therapy.

    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.

  • GAD-7: Generalized Anxiety Disorder - 7Participants are actively involved in the study for at least 90 days (approximately 3 months) following the initiation of PAP therapy

    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

  • PCL-5 - PTSD Checklist for DSM-5Participants are actively involved in the study for at least 90 days (approximately 3 months) following the initiation of PAP therapy.

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

  • WPAI: Work Productivity and Activity Impairment QuestionnaireParticipants are actively involved in the study for at least 90 days (approximately 3 months) following the initiation of PAP therapy

    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

  • RE-AIM: Reach, Effectiveness, Adoption, Implementation, MaintenanceParticipants are actively involved in the study for at least 90 days (approximately 3 months) following the initiation of PAP therapy.

    Modified questionnaire to measure patient satisfaction. Formative evaluation

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

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