Obstructive Sleep Apnea (OSA)TS OSANCT07121452
Telehealth for Sleep Apnea: Effectiveness, Implementation, and Cost in the Military Health System
A study testing Sleep Navigator in people with Obstructive Sleep Apnea (OSA), run by Uniformed Services University of the Health Sciences at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- What is being tested?
- Sleep Navigator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Oct 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Active-duty military service members (ADSM)
- Untreated major medical or psychiatric illness
- Pursuit of non-PAP treatment for OSA
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Uniformed Services University
Bethesda, Maryland, 20814
Pewu J Lavela, B.S, 301-319-4930, pewu.lavela.ctr@usuhs.edu
Manisha K Djohi, M.S., manisha.djohi.ctr@usuhs.edu
- Recruiting
Walter Reed National Military Medical Center
Bethesda, Maryland, 20814
Eungjae Kim, MD, MHPE, 214-603-3577, eungjae.kim@usuhs.edu
About this study
Official title: Tele-Sleep OSA: Clinical Effectiveness, Implementation, and Economic Impact of Telehealth Care for Obstructive Sleep Apnea in the Military Health System
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).
Read more
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.
Read the detailed description
Obstructive sleep apnea (OSA) is a common and costly chronic medical condition that impacts approximately 27% of men and 9% of women in the U.S. and approximately 936 million adults worldwide. Within the military health system (MHS), the prevalence of OSA is approximately 51.2% and rapidly increasing (e.g., from 11 to 333 per 10,000 ADSMs between the years of 2005 and 2019).3 OSA is characterized by repetitive breathing pauses throughout the night, each lasting a minimum of ten seconds, resulting in blood oxygen desaturations and associated cortical arousals during sleep, as the brain tries harder to breathe and obtain needed oxygen. OSA is associated with worsened medical (cardiovascular disease, stroke, metabolic syndromes [including Type 2 diabetes], and premature death) and mental health (depression, anxiety, traumatic stress, substance misuse) outcomes, and worsened quality of life. Beyond these health consequences, OSA is also associated with dramatically increased costs, including both direct treatment costs as well as indirect costs such as increased risk for motor vehicle crash, lost workplace productivity, and costly workplace accidents and errors. The adverse impact of OSA on readiness and deployability for the Armed Services is also extremely costly. Within the context of the MHS, all direct and most indirect costs are borne by the Defense Health Agency (DHA).
The most common treatment for OSA is positive airway pressure (PAP) therapy. PAP involves a small mask that fits over the nose (or mouth and nose) and gently blows air, creating a pneumatic splint that holds the airway open during sleep. When used as prescribed, PAP results in myriad health benefits, including dramatic reductions in sleepiness and risks associated with sleepiness (e.g., motor vehicle crash), as well as improvements in health-related quality of life (HrQOL), memory, blood pressure, other mental and physical health benefits with high military relevance, and reduced costs.
Unfortunately, despite the high prevalence and well-documented consequences of OSA in the MHS, few studies have examined the impact of OSA treatment on clinical and economic outcomes in the MHS.
Within the MHS there is a gross shortage of trained sleep specialist providers and accredited sleep centers. Thus, the demand for sleep medicine specialty care greatly exceeds available supply. As a result, most MHS beneficiaries receive sleep medicine specialty care through the civilian network and TRICARE contracted providers (i.e., standard purchased care). A typical course of OSA private sector care includes multiple billed face-to-face encounters with a sleep medicine physician, in-lab sleep studies, and provision of PAP equipment billed through various third-party durable medical equipment (DME) providers that are also contracted with TRICARE. Given very high volumes, the costs of standard purchased care borne by the DHA are substantial, and quality is variable. Further, patients often struggle to navigate this complex care process that involves multiple providers with suboptimal care coordination (e.g., primary care, specialty care, DME). Optimizing the approach to OSA care is a vital consideration.
In non-MHS samples, OSA telehealth care has demonstrated clinical non-inferiority and enhanced cost-effectiveness relative to OSA in-person care, while also increasing access to care. For example, home sleep apnea testing (HSAT) and auto-titrating positive airway pressure (APAP) have been extensively validated as viable alternatives to attended in-lab diagnostic sleep studies (i.e., polysomnogram [PSG]) and attended in lab therapeutic sleep studies (i.e., manual PAP titration), respectively. In addition, several studies have highlighted the potential role of non-sleep specialists - including non-physician providers - to increase access to OSA care and deliver high quality OSA care. These findings are especially notable given both the major "virtual first" DHA initiative as well as the DHA Quadruple Aim: improved health readiness, better health, better care, and lower cost. Even so, there remain important gaps in knowledge, particularly from the DHA perspective.
Results from this study are expected to be highly generalizable to ADFM and DEERS beneficiaries diagnosed with obstructive sleep apnea (OSA). Given the prevalence of OSA, the investigators aim to be as inclusive as possible to capture a diverse representation of sex, race/ethnicity, and age.
Within the military health system (MHS), the prevalence of OSA is very high and rapidly increasing. OSA is associated with numerous adverse health consequences, dramatically increased economic costs (including both direct treatment costs as well as indirect costs) and reduced military readiness.
At the same time, there exists a dearth of sleep medicine specialists within the MHS, and demand for sleep specialty care greatly exceeds available supply.
Thus, the proposed study has direct military relevance because OSA telehealth care, if found effective, could be disseminated throughout the military as an evidence-based, cost-effective, broad-reaching, and convenient treatment approach to increase access to care. Hence this project is very timely, highly innovative, and scientifically sound, with great potential to enhance military telehealth efforts.
- Conditions
- Obstructive Sleep Apnea (OSA)
- Being tested
- Sleep Navigator
- Keywords
- sleep, sleep apnea, treatment, telehealth, implementation
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep NavigatorBehavioural
Also called MedBridge
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.
| Study group | Role | What they receive |
|---|---|---|
| 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]). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-Hypopnea Index (AHI): Assesses OSA severity via events/hour from diagnostic testing.
Unit: Events/hour
Scale: Continuous; higher values = more severe outcome
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: Participants are actively involved in the study for at least 90 days (approximately 3 months) following the initiation of PAP therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start15 Oct 2025
- Primary completion31 Jan 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uniformed Services University of the Health Sciences
- Sponsor type
- US federal agency
- Collaborators
- University of Maryland, Baltimore
- Responsible party
- Sponsor
- Investigators
- Vincent F Capaldi II, M.D, Principal investigator, Uniformed Services University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121452
- Sponsor's protocol ID
- USUHS.2024-142
- Other IDs
- HT94252410479
- Acronym
- TS OSA
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2025
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wickwire EM, Capaldi VF 2nd, So JY, Kim E, Thomas C, Johnston CW, Maggio S, Elmore JS, Albrecht JS, Verceles AC, Chen S. TELE-SLEEP OSA: A protocol for a hybrid type I randomized clinical trial of telemedicine for obstructive sleep apnea among military dependents and retirees. Contemp Clin Trials. 2026 Mar;162:108252. doi: 10.1016/j.cct.2026.108252. Epub 2026 Feb 4.
PubMed 41651286
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-Sleep OSA: Clinical Effectiveness, Implementation, and Economic Impact of Telehealth Care for Obstructive Sleep Apnea in the Military Health System
- ClinicalTrials.gov ID
- NCT07121452
- Acronym / sponsor ID
- TS OSA / USUHS.2024-142
- Conditions
- Obstructive Sleep Apnea (OSA)
- Keywords
- sleep, sleep apnea, treatment, telehealth, implementation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Uniformed Services University of the Health SciencesUS federal agency
- Collaborators
- University of Maryland, Baltimore
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Obstructive sleep apnea (OSA) is a common and costly chronic medical condition that impacts approximately 27% of men and 9% of women in the U.S. and approximately 936 million adults worldwide. Within the military health system (MHS), the prevalence of OSA is approximately 51.2% and rapidly increasing (e.g., from 11 to 333 per 10,000 ADSMs between the years of 2005 and 2019).3 OSA is characterized by repetitive breathing pauses throughout the night, each lasting a minimum of ten seconds, resulting in blood oxygen desaturations and associated cortical arousals during sleep, as the brain tries harder to breathe and obtain needed oxygen. OSA is associated with worsened medical (cardiovascular disease, stroke, metabolic syndromes [including Type 2 diabetes], and premature death) and mental health (depression, anxiety, traumatic stress, substance misuse) outcomes, and worsened quality of life. Beyond these health consequences, OSA is also associated with dramatically increased costs, including both direct treatment costs as well as indirect costs such as increased risk for motor vehicle crash, lost workplace productivity, and costly workplace accidents and errors. The adverse impact of OSA on readiness and deployability for the Armed Services is also extremely costly. Within the context of the MHS, all direct and most indirect costs are borne by the Defense Health Agency (DHA).
The most common treatment for OSA is positive airway pressure (PAP) therapy. PAP involves a small mask that fits over the nose (or mouth and nose) and gently blows air, creating a pneumatic splint that holds the airway open during sleep. When used as prescribed, PAP results in myriad health benefits, including dramatic reductions in sleepiness and risks associated with sleepiness (e.g., motor vehicle crash), as well as improvements in health-related quality of life (HrQOL), memory, blood pressure, other mental and physical health benefits with high military relevance, and reduced costs.
Unfortunately, despite the high prevalence and well-documented consequences of OSA in the MHS, few studies have examined the impact of OSA treatment on clinical and economic outcomes in the MHS.
Within the MHS there is a gross shortage of trained sleep specialist providers and accredited sleep centers. Thus, the demand for sleep medicine specialty care greatly exceeds available supply. As a result, most MHS beneficiaries receive sleep medicine specialty care through the civilian network and TRICARE contracted providers (i.e., standard purchased care). A typical course of OSA private sector care includes multiple billed face-to-face encounters with a sleep medicine physician, in-lab sleep studies, and provision of PAP equipment billed through various third-party durable medical equipment (DME) providers that are also contracted with TRICARE. Given very high volumes, the costs of standard purchased care borne by the DHA are substantial, and quality is variable. Further, patients often struggle to navigate this complex care process that involves multiple providers with suboptimal care coordination (e.g., primary care, specialty care, DME). Optimizing the approach to OSA care is a vital consideration.
In non-MHS samples, OSA telehealth care has demonstrated clinical non-inferiority and enhanced cost-effectiveness relative to OSA in-person care, while also increasing access to care. For example, home sleep apnea testing (HSAT) and auto-titrating positive airway pressure (APAP) have been extensively validated as viable alternatives to attended in-lab diagnostic sleep studies (i.e., polysomnogram [PSG]) and attended in lab therapeutic sleep studies (i.e., manual PAP titration), respectively. In addition, several studies have highlighted the potential role of non-sleep specialists - including non-physician providers - to increase access to OSA care and deliver high quality OSA care. These findings are especially notable given both the major "virtual first" DHA initiative as well as the DHA Quadruple Aim: improved health readiness, better health, better care, and lower cost. Even so, there remain important gaps in knowledge, particularly from the DHA perspective.
Results from this study are expected to be highly generalizable to ADFM and DEERS beneficiaries diagnosed with obstructive sleep apnea (OSA). Given the prevalence of OSA, the investigators aim to be as inclusive as possible to capture a diverse representation of sex, race/ethnicity, and age.
Within the military health system (MHS), the prevalence of OSA is very high and rapidly increasing. OSA is associated with numerous adverse health consequences, dramatically increased economic costs (including both direct treatment costs as well as indirect costs) and reduced military readiness.
At the same time, there exists a dearth of sleep medicine specialists within the MHS, and demand for sleep specialty care greatly exceeds available supply.
Thus, the proposed study has direct military relevance because OSA telehealth care, if found effective, could be disseminated throughout the military as an evidence-based, cost-effective, broad-reaching, and convenient treatment approach to increase access to care. Hence this project is very timely, highly innovative, and scientifically sound, with great potential to enhance military telehealth efforts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSA telehealth care | Experimental | Behavioral: Sleep NavigatorParticipants 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]). |
| 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep NavigatorAlso: MedBridgeSleep 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. | Behavioural | OSA telehealth care |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Derived from this study: PubMed 41651286Wickwire EM, Capaldi VF 2nd, So JY, Kim E, Thomas C, Johnston CW, Maggio S, Elmore JS, Albrecht JS, Verceles AC, Chen S. TELE-SLEEP OSA: A protocol for a hybrid type I randomized clinical trial of telemedicine for obstructive sleep apnea among military dependents and retirees. Contemp Clin Trials. 2026 Mar;162:108252. doi: 10.1016/j.cct.2026.108252. Epub 2026 Feb 4.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vincent F Capaldi II, M.D principal investigator
Uniformed Services University Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Navigator in people with Obstructive Sleep Apnea (OSA), run by Uniformed Services University of the Health Sciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pewu J Lavela, B.S (301-319-4930, pewu.lavela.ctr@usuhs.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07121452, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.