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

Trial Summary

What is the purpose of this trial?

This study seeks to enhance long-term positive airway pressure (PAP) adherence among Spanish-speaking Hispanics, a group with known PAP outcomes disparities. This study will assess the feasibility of a linguistically and culturally adapted tele-management intervention (Automated Management, AM) for Spanish-speaking Hispanic adults with OSA.

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 data supports the effectiveness of the treatment Automated Management for Sleep Apnea?

Research shows that using telemonitoring (remote tracking of health data) and telemedicine (remote medical care) can help people stick to their CPAP therapy, which is a common treatment for sleep apnea. This suggests that similar automated management approaches could be effective in improving treatment adherence for sleep apnea. ^{1 2 3 4 5}

Is Automated Management for Sleep Apnea safe for humans?

The research articles reviewed focus on the use of telemonitoring for managing sleep apnea with continuous positive airway pressure (CPAP) devices. They do not provide specific safety data for Automated Management or similar interventions, but they highlight the importance of monitoring and adjusting treatment to improve compliance and effectiveness, suggesting a focus on patient safety and care. ^{5 6 7 8 9}

How is the Automated Management treatment for sleep apnea different from other treatments?

Automated Management for sleep apnea is unique because it uses telemedicine (remote healthcare) to monitor and adjust treatment, such as CPAP (continuous positive airway pressure) therapy, remotely. This approach helps improve patient adherence by providing real-time feedback and support, which is not typically available with standard treatments. ^{2 3 5 10 11}

Research Team

Bruno Saconi, PhD

Principal Investigator

Geisinger Clinic

Eligibility Criteria

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)

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Using the Remote Monitoring Framework to Promote Adherence to Continuous Positive Airway Pressure. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Multimodal Telemonitoring for Weight Reduction in Patients With Sleep Apnea: A Randomized Controlled Trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Effect of Telemedicine Education and Telemonitoring on Continuous Positive Airway Pressure Adherence. The Tele-OSA Randomized Trial. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

Telemonitoring of CPAP therapy may save nursing time. [2022]

5. Germany 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. [2022]

6. France pubmed.ncbi.nlm.nih.gov

[Telemonitoring in continuous positive airway pressure-treated patients with obstructive sleep apnoea syndrome: An algorithm proposal]. [2020]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Telemonitoring in continuous positive airway pressure-treated patients improves delay to first intervention and early compliance: a randomized trial. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Telemonitoring for the Follow-Up of Obstructive Sleep Apnea Patients Treated with CPAP: Accuracy and Impact on Therapy. [2022]

9. Germany 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. [2021]

10. England pubmed.ncbi.nlm.nih.gov

A telemedicine intervention to improve adherence to continuous positive airway pressure: a randomised controlled trial. [2022]

11. Japan pubmed.ncbi.nlm.nih.gov

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