Telehealth for Sleep Apnea

(TS OSA Trial)

Recruiting at 1 trial location

Overseen By Manisha K Djohi, M.S.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Uniformed Services University of the Health Sciences

Disqualifiers: Prior OSA care, Substance dependence, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if telehealth care for sleep apnea, which includes guidance from a sleep expert and the use of the Sleep Navigator (a telehealth tool), is as effective and more cost-efficient than traditional care. Participants will either receive standard care through private providers or engage in telehealth sessions, including virtual consultations and home testing. The goal is to improve sleep habits and adherence to treatment among military service members and their families. Ideal candidates are TRICARE beneficiaries recently diagnosed with sleep apnea who have access to a smartphone or computer.

As an unphased trial, this study offers participants the chance to contribute to innovative care solutions that could enhance treatment accessibility and effectiveness.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this telehealth method is safe for treating sleep apnea?

Research has shown that telehealth for sleep apnea is generally safe and well-received. Studies have found that telehealth can effectively monitor and support treatment for obstructive sleep apnea (OSA), including tracking therapy progress and helping patients adhere to their treatment plans.

Evidence also suggests that telehealth matches the effectiveness of traditional care, allowing patients to receive the same quality of care through online platforms. A human sleep navigator, often a certified sleep health educator, adds a personal touch to telehealth care, ensuring patients understand their treatment and feel supported throughout the process.

Overall, current research supports the safety and effectiveness of telehealth in managing sleep apnea. No significant reports of negative effects have been associated with its use, making it a promising option for those considering participation in a clinical trial for sleep apnea treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the telehealth approach to sleep apnea because it offers a new way to deliver care that could make treatment more accessible. Unlike traditional in-person visits, this method uses secure video conferencing for evaluations and ongoing support, which might be more convenient for patients. Additionally, it incorporates home sleep apnea testing and personalized education, potentially leading to better patient engagement and adherence to treatment. This approach could transform how sleep apnea is managed by making it easier and more efficient for patients to get the help they need.

What evidence suggests that OSA telehealth care is effective for sleep apnea?

Research has shown that telehealth tools, such as a Sleep Navigator, can effectively assist people with sleep apnea. In this trial, participants in the OSA telehealth care arm will receive clinical evaluation and treatment through secure video conferencing, including diagnostic testing and PAP therapy initiation. Studies have found that telemedicine improves adherence to positive airway pressure (PAP) therapy in patients with obstructive sleep apnea (OSA). One study showed that individuals with OSA using telehealth experienced similar improvements to those receiving regular in-person care. Another study found that telehealth for OSA reduced the need for additional doctor's visits, saving time and effort. Overall, telehealth appears to be a practical and effective way to manage sleep apnea. ^{1 3 6 7 8}

Who Is on the Research Team?

Vincent F Capaldi II, M.D

Principal Investigator

Uniformed Services University Health Sciences

Are You a Good Fit for This Trial?

This trial is for military service members with obstructive sleep apnea syndrome (OSA). It aims to test if telehealth care, including help from a 'sleep navigator,' is as effective and more cost-efficient than private sector care. Specific eligibility criteria are not provided.

Inclusion Criteria

ADFM or DEERS beneficiary

Access to smartphone, desktop, laptop, or tablet computer

I am between 18 and 64 years old.

Exclusion Criteria

Untreated major medical or psychiatric illness

I have been tested, diagnosed, or treated for sleep apnea before.

I am seeking treatment for sleep apnea that isn't CPAP.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo OSA clinical evaluation via secure video conferencing, complete diagnostic OSA testing via home sleep apnea test (HSAT), receive comprehensive sleep education, and initiate PAP therapy via auto-titrating PAP (APAP).

12 weeks

Initial consultation and ongoing support via secure video conferencing

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of PAP adherence, healthcare utilization, and various health outcomes.

4 weeks

Open-label extension (optional)

Participants may opt into continuation of telehealth care for long-term management of OSA.

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Sleep Navigator

Trial Overview The study compares the effectiveness of OSA telehealth care, which includes support from a human sleep navigator, against traditional private sector care. The focus is on adherence to positive airway pressure therapy, symptom reduction, patient satisfaction, and cost-effectiveness.

How Is the Trial Designed?

Group I: OSA telehealth care Experimental Treatment 1 Intervention

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 \[CCSH\]).

Group II: Private Sector Care Active Control 1 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 Is Running the Clinical Trial?

Uniformed Services University of the Health Sciences

Lead Sponsor

Trials

130

Recruited

91,100+

University of Maryland, Baltimore

Collaborator

Trials

729

Recruited

540,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11084346/

The Future of Telemedicine for Obstructive Sleep Apnea ... Multimodal telemonitoring proves effective among OSA patients with increased cardiovascular risk, enhancing adherence to CPAP therapy and ...

2. frontiersin.org frontiersin.org/journals/sleep/articles/10.3389/frsle.2025.1593874/full

Managing sleep apnea: long-term outcomes from a ... The purpose of this study was to determine the impact of a streamlined OSA care pathway on quality of care and PAP adoption/adherence.

3. journals.sagepub.com journals.sagepub.com/doi/10.1177/20552076241293928

Telemedicine for obstructive sleep apnea syndrome These data can aid health care professionals in assessing a patient's condition more accurately and developing a more effective treatment plan.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03007745

Remote Diagnosis and Management of Obstructive Sleep ... Non-inferiority of clinical effectiveness following 3 months of APAP treatment will be expressed in terms of improvement in the score of the Functional Outcomes ...

5. sleepwakeadvisor.com sleepwakeadvisor.com/news/telemedicine-reduces-clinical-time-in-patients-with-obstructive-sleep-apnea/

Telemedicine Reduces Clinical Time in Patients With ... Telemedicine reduced time spent with patients at the first follow-up, and reduced the number of additional appointments in standard care ...

6. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.11438

Recommendations for permanent sleep telehealth Telehealth is noninferior for delivery of cognitive behavioral therapy for insomnia and can enhance obstructive sleep apnea treatment adherence. It is the ...

7. publications.ersnet.org publications.ersnet.org/content/erj/early/2025/08/28/1399300300557-2025

European Respiratory Society statement on advanced ... Because obstructive sleep apnoea (OSA) is a chronic condition, and requires a continuous treatment and monitoring of therapy success, telematic ...

8. liebertpub.com liebertpub.com/doi/10.1089/tmj.2024.0573

Telemedicine in the Management of Patients with ... Telemedicine (TM) has been explored as a tool to monitor both physiological parameters during sleep and treatment outcomes.