NCT07121452 · Uniformed Services University of the Health Sciences
Telehealth for Sleep Apnea: Effectiveness, Implementation, and Cost in the Military Health System
(TS OSA)
What this study is about
The long-term goal of this research is to improve military health and operational readiness among military service members with sleep disorders.
View original scientific description
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.
Interventions
BEHAVIORAL
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 measures
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.
Unit: Events/hour Scale: Continuous; higher values = more severe outcome
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
Units: Nadir (%), Time \<90% (% of total sleep time) Scale: Continuous; lower nadir = worse outcome, higher time \<90% = worse outcome
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.
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
Time frame: Participants 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 Index
Time frame: Participants 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 Scale
Time frame: Participants 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 Questionnaire
Time frame: Participants 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 12
Time frame: Participants 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 8
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: 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 - 7
Time frame: Participants 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-5
Time frame: Participants 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 Questionnaire
Time frame: Participants 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, Maintenance
Time frame: Participants 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 Utilization
Time frame: Participants 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Where
- Bethesda, Maryland
Collaborators
University of Maryland, Baltimore
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 10, 2025 · Source of record for eligibility and locations