Automated Management for Sleep Apnea

Recruiting at 3 trial locations

Overseen By Dennis X Hwang, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Geisinger Clinic

Disqualifiers: Other sleep apnea, Oxygen, Pregnancy, Bariatric, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to improve adherence to positive airway pressure (PAP) therapy among Spanish-speaking Hispanic adults with obstructive sleep apnea (OSA). It will test a new tele-management system called Automated Management (AM), which provides text-based support for treatment. The trial will compare this method to the usual care for sleep apnea. This study suits Spanish-speaking Hispanic adults with moderate to severe OSA who already use PAP therapy, particularly those with a smartphone and unlimited texting. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance treatment adherence for others.

Will I have to stop taking my current medications?

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

What prior data suggests that this tele-management intervention is safe for Spanish-speaking Hispanic adults with OSA?

Research has shown that using telemedicine to manage sleep apnea is safe and effective. Studies have found that telemedicine, including automated management systems, helps people adhere to their CPAP (Continuous Positive Airway Pressure) treatment. CPAP keeps airways open during sleep.

One study found that people using CPAP with remote check-ins used their machines more consistently over 90 days. Another study demonstrated that remote monitoring devices for sleep apnea patients are practical and can be implemented without major issues.

Overall, these findings suggest that automated management for sleep apnea is well-tolerated and helps ensure continued treatment, which is crucial for managing the condition. No serious side effects or problems were reported in these studies, making this approach a safe option for consideration. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Automated Management (AM) approach for sleep apnea because it offers a novel way to manage the condition through a text-based behavioral intervention. Unlike traditional treatments like CPAP machines or oral appliances, which focus on physical intervention, AM aims to enhance patient engagement and adherence through digital communication. This method could potentially improve long-term management of sleep apnea by integrating behavioral support, making it more accessible and personalized compared to conventional approaches.

What evidence suggests that Automated Management is effective for sleep apnea?

Research shows that remote monitoring and telemedicine can help people adhere to CPAP (continuous positive airway pressure) therapy for obstructive sleep apnea (OSA). Many patients struggle to continue using CPAP, with up to 50% stopping within three years. Studies have found that telemedicine and automated tools improve adherence by providing personalized support and reminders, leading to better health outcomes. This trial will compare an Automated Management (AM) system, which offers a text-based behavioral intervention, with usual care. This method has successfully helped people stay on track with their treatment. For Spanish-speaking Hispanics, a culturally tailored tele-management system may further enhance their CPAP use and overall treatment success. ^{2 4 5 6 7}

Who Is on the Research Team?

Bruno Saconi, PhD

Principal Investigator

Geisinger Clinic

Are You a Good Fit for This Trial?

This trial is for Spanish-speaking Hispanic adults over 18 with moderate to severe obstructive sleep apnea (OSA), who are starting PAP therapy and own a smartphone with texting. It's not for those planning weight loss surgery, have other respiratory conditions, need extra oxygen, or women referred to PAP due to pregnancy-related OSA.

Inclusion Criteria

Ownership of smartphone with unlimited text messaging capability

Expected availability for the duration of the study (6 months from date of randomization)

You identify yourself as Hispanic.

Exclusion Criteria

I need extra oxygen or a device to help me breathe.

I have a sleep disorder diagnosed other than OSA, confirmed by a sleep study.

I am pregnant and have been referred for sleep apnea treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a tele-management intervention to enhance PAP adherence, including education, support, and motivational enhancement

6 months

Tele-management sessions

Follow-up

Participants are monitored for PAP adherence and satisfaction with care

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Automated Management (AM)

Trial Overview The study tests a tele-management intervention called Automated Management (AM) designed specifically for Spanish-speaking Hispanics with OSA. The goal is to see if AM can improve long-term use of positive airway pressure (PAP) machines in this group.

How Is the Trial Designed?

Group I: Automated Management (AM) Experimental Treatment 1 Intervention

Receipt of text-based behavioral intervention

Group II: Usual Care Active Control 1 Intervention

Control group receiving usual care for obstructive sleep apnea

Automated Management (AM) is already approved in United States for the following indications:

Approved in United States as Automated Management (AM) for:

• Improving Positive Airway Pressure (PAP) adherence in Obstructive Sleep Apnea (OSA)

Who Is Running the Clinical Trial?

Geisinger Clinic

Lead Sponsor

Trials

159

Recruited

1,976,000+

American Academy of Sleep Medicine

Collaborator

Trials

29

Recruited

3,000+

Published Research Related to This Trial

In a study of 168 patients with obesity and obstructive sleep apnea (OSA) using CPAP therapy, those in the multimodal telemonitoring group achieved a greater weight reduction (≥3% weight loss) compared to the usual CPAP telemonitoring group (39.3% vs 25.0%, P = 0.047).

Participants in the multimodal telemonitoring group also increased their daily step counts significantly, averaging 4,767 steps per day compared to 3,592 steps per day in the usual group (P = 0.02), indicating that enhanced monitoring and feedback can improve physical activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal Telemonitoring for Weight Reduction in Patients With Sleep Apnea: A Randomized Controlled Trial. Murase, K., Minami, T., Hamada, S., et al.[2022]

Telemonitoring (TM) significantly reduced the delay to the first technical intervention for patients using CPAP, with an average of 29 days compared to 47 days in the usual care group, indicating quicker problem detection and resolution.

Patients using TM showed better compliance with CPAP treatment after 3 months, averaging 5.7 hours per night compared to 4.2 hours in the usual care group, suggesting that TM can enhance long-term acceptance of CPAP therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemonitoring in continuous positive airway pressure-treated patients improves delay to first intervention and early compliance: a randomized trial. Hoet, F., Libert, W., Sanida, C., et al.[2018]

Continuous positive airway pressure (CPAP) telemonitoring (TMg) is effective in enhancing compliance and managing therapy for patients with obstructive sleep apnea (OSA), providing valuable data on usage and respiratory events.

Despite its benefits, there are limitations in the accuracy of CPAP devices for measuring residual respiratory events and leaks, and concerns regarding privacy and cost-effectiveness need to be addressed in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemonitoring for the Follow-Up of Obstructive Sleep Apnea Patients Treated with CPAP: Accuracy and Impact on Therapy. Dusart, C., Andre, S., Mettay, T., et al.[2022]

Telemonitoring of CPAP devices is crucial for tracking patient adherence, leak rates, and the apnoea-hypopnoea index (AHI), which are important for effective treatment of sleep apnea.

The workgroup provides guidelines for CPAP prescribers and home care providers, including alert thresholds for leaks and AHI, mechanisms causing issues, and a diagnostic algorithm to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Telemonitoring in continuous positive airway pressure-treated patients with obstructive sleep apnoea syndrome: An algorithm proposal]. Prigent, A., Gentina, T., Launois, S., et al.[2020]

Remote monitoring of positive airway pressure therapy can significantly enhance patient adherence and treatment efficacy, as shown by both smaller randomized studies and larger retrospective evaluations.

There is a need for more research to understand the long-term effects of telemedicine interventions on adherence and patient-reported outcomes, suggesting that integrating remote monitoring data with electronic health records could greatly benefit sleep medicine practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the Remote Monitoring Framework to Promote Adherence to Continuous Positive Airway Pressure. Keenan, BT., Schwab, RJ.[2021]

Wireless telemonitoring during the initial phase of CPAP therapy for obstructive sleep apnea (OSAS) significantly reduced nursing time (39 minutes vs. 58 minutes in usual care), while maintaining high adherence and satisfaction levels among patients.

Both telemonitoring and usual care groups showed similar CPAP usage (around 6.4 hours vs. 6.1 hours) and effective treatment outcomes, with the telemonitoring group demonstrating a lower residual apnea-hypopnea index (AHI) at one year (1.3 vs. 3.2), indicating effective long-term management of OSAS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemonitoring of CPAP therapy may save nursing time. Anttalainen, U., Melkko, S., Hakko, S., et al.[2022]

In a study of 212 newly diagnosed obstructive sleep apnea patients using telemonitoring, pressure modification was the only technical intervention that significantly improved CPAP compliance by over 30 minutes per night.

The study found that while the acceptance rate for telemonitoring was high (87%), 13% of patients stopped using CPAP, and 17% were non-compliant, highlighting the need for effective interventions to enhance adherence to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pressure adjustment is the most useful intervention for improving compliance in telemonitored patients treated with CPAP in the first 6 months of treatment. Carlier, S., Bruyneel, AV., Bruyneel, M.[2022]

Telemonitoring is a valuable tool for healthcare professionals to remotely monitor patients using positive airway pressure (PAP) therapy, enabling timely adjustments to improve treatment adherence.

The proposed management model emphasizes the importance of patient privacy regarding data shared during telemonitoring, ensuring that patients are informed and give consent for their information to be used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proposed management model for the use of telemonitoring of adherence to positive airway pressure equipment - position paper of the Brazilian Association of Sleep Medicine - ABMS. Vidigal, TA., Brasil, EL., Ferreira, MN., et al.[2021]

The automated telemedicine intervention, TLC-CPAP, significantly improved CPAP adherence in patients with obstructive sleep apnoea, with an increase of about 1 hour per night at 6 months and 2 hours per night at 12 months compared to a control group of 126 patients.

Improved adherence to CPAP was linked to reductions in sleep apnoea symptoms and depressive symptoms, as well as enhancements in functional status, highlighting the intervention's potential benefits beyond just increased usage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A telemedicine intervention to improve adherence to continuous positive airway pressure: a randomised controlled trial. Sparrow, D., Aloia, M., Demolles, DA., et al.[2022]

In a study involving 1,455 patients with suspected obstructive sleep apnea, CPAP telemonitoring with automated feedback significantly improved adherence to therapy, with an average daily use of 4.4 hours compared to 3.8 hours in usual care.

While telemedicine education did not significantly enhance CPAP adherence, it did lead to better clinic attendance for evaluations, indicating its potential value in patient engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Telemedicine Education and Telemonitoring on Continuous Positive Airway Pressure Adherence. The Tele-OSA Randomized Trial. Hwang, D., Chang, JW., Benjafield, AV., et al.[2019]

Telemedicine is being effectively utilized for diagnosing sleep-disordered breathing, including obstructive sleep apnea, through home testing and remote monitoring, which enhances accessibility for patients.

The AILIFE system, developed in 1994, aims to improve treatment outcomes for obstructive sleep apnea by providing personalized lifestyle guidance via telecare, potentially increasing the effectiveness of various treatments like CPAP and surgical options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Telemedicine and lifestyle modifications in obstructive sleep apnea patients]. Shiomi, T.[2011]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11874751/

Management of CPAP Follow-up by Telemonitoring in ... CPAP is the standard treatment for obstructive sleep apnea (OSA), but as many as 50% of patients discontinue its use, within three years.

2. frontiersin.org frontiersin.org/journals/sleep/articles/10.3389/frsle.2025.1601389/full

Remote monitoring of patients with obstructive sleep apnea ... This study explores the feasibility of utilizing connected devices to remotely monitor OSAS patients undergoing CPAP treatment.

3. mdpi.com mdpi.com/2077-0383/14/15/5339

Telemedicine-Supported CPAP Therapy in Patients with ... Telemedicine-Supported CPAP Therapy in Patients with Obstructive Sleep Apnea: Association with Treatment Adherence and Clinical Outcomes. by. Norbert Wellmann.

4. publications.ersnet.org publications.ersnet.org/content/errev/28/151/180093

Telemedicine in the diagnosis and treatment of sleep apnoea The first TM studies were designed using automated TM tools such as interactive websites [38], interactive telephone-based voice response systems [39], or daily ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7055847/

Effectiveness of eHealth Interventions in Improving ... Most studies adding eHealth components alone used telemonitoring tools (n=7) to monitor CPAP adherence and efficacy data, and telephone calls (n=7) intended to ...

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

The Future of Telemedicine for Obstructive Sleep Apnea ... Telemedicine-based interventions (TM) have been evaluated to improve access to diagnosis, increase CPAP adherence, and contribute to easing the ...

7. atsjournals.org atsjournals.org/doi/abs/10.1164/rccm.201703-0582OC

American Journal of Respiratory and Critical Care Medicine 62.7%; P = 0.02). Conclusions: The use of CPAP telemonitoring with automated feedback messaging improved 90-day adherence in patients with OSA.