App-Based Support for Obstructive Sleep Apnea

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Benzodiazepines, Opioids

Disqualifiers: Cognitive impairments, Claustrophobia, Shiftwork, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with obstructive sleep apnea (OSA) adhere to their CPAP therapy using a smartphone app called SleepWell24. The app supports users in achieving the goal of using their CPAP machines for at least 6 hours a night, 6 nights a week. Participants must be newly diagnosed with OSA, use a CPAP machine, and have a smartphone they can operate. This study is ideal for English-speaking individuals seeking to improve their nightly CPAP usage without interference from other lifestyle programs. As an unphased trial, this study offers a unique opportunity to enhance the CPAP therapy experience with innovative technology.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are prescribed high-dose benzodiazepines or use daily opioid medication at night.

What prior data suggests that the SleepWell24 application is safe for use in people with obstructive sleep apnea?

Research has shown that the SleepWell24 app was tested to determine its effectiveness in helping people with sleep apnea adhere to their treatment. Specific safety data for this app is not yet available. As this study is in an early stage, limited safety information is common. However, the absence of reports on serious side effects suggests it is likely safe for users. The app employs behavior change strategies and real-time monitoring to encourage increased use of CPAP machines. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SleepWell24 app because it offers a fresh approach to managing obstructive sleep apnea. Traditional treatments like CPAP machines can be cumbersome and uncomfortable for many users. Unlike these options, SleepWell24 provides digital support through a smartphone app, making it more convenient and accessible. This app aims to engage users with personalized feedback and behavioral strategies, potentially improving adherence and outcomes without the need for bulky equipment.

What evidence suggests that the SleepWell24 application is effective for improving CPAP adherence in OSA?

Studies have shown that the SleepWell24 app helps people use their CPAP machines more regularly. The app provides feedback on CPAP usage and tracks sleep and activity. Research indicates that users find SleepWell24 more acceptable and helpful compared to usual care. Early findings suggest the app may improve adherence to CPAP treatment for sleep apnea. This improvement could help users stick to their treatment plan, which is crucial for managing obstructive sleep apnea (OSA). ^{1 2 3 4 5}

Who Is on the Research Team?

Timothy Morgenthaler, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with Obstructive Sleep Apnea (OSA) who are looking to improve their use of CPAP machines. The goal is to help them use the machine at least 6 hours a night, for 6 nights a week, using an app called SleepWell24.

Inclusion Criteria

Speak and read English

I can use a smartphone with iOS9/Android 4.2 or higher by myself.

Agree to using a smartphone application and wearable wrist sensor

Exclusion Criteria

Currently participating in other lifestyle programs (e.g. active, formal weight loss program or research study; smoking cessation program, etc.)

Previous CPAP use

Currently engaging in shiftwork defined as night shift or rotating day and night shifts

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the SleepWell24 application to optimize CPAP adherence for 8 weeks

8 weeks

Weekly virtual assessments

Extended Treatment

A 6-month cohort for CPAP adherence using the SleepWell24 application

6 months

Weekly virtual assessments

Follow-up

Participants are monitored for changes in quality of life, sleep time, and physical activity

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SleepWell24 Application

Trial Overview

The study tests whether the SleepWell24 smartphone application can increase adherence to CPAP therapy among OSA patients. It aims to optimize long-term usage and enhance quality of life by encouraging regular use.

How Is the Trial Designed?

Group I: SleepWell24 Smart Application Experimental Treatment 1 Intervention

This group will consists of participates who will be on study for 8 weeks using the Sleepwell24 application. Once 20 people are enrolled on the 8 week cohort, a 6 month cohort will open up for 20 different participants.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Arizona State University (ASU)

Collaborator

Trials

1

Recruited

40+

Published Research Related to This Trial

Out of 126 snoring apps evaluated, 13 were found to be user-friendly, with the Quit Snoring app receiving the highest rating for its ability to graphically display snoring events and accurately record snoring sounds.

In a comparison with polysomnography, the Quit Snoring app showed high sensitivity (64-96%) and positive predictive values (93-96%), and a chronic snorer using the app reported a significant reduction in snoring frequency and partner complaints after one month of use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone apps for snoring. Camacho, M., Robertson, M., Abdullatif, J., et al.[2015]

The Jawbone UP3 fitness tracker significantly overestimated total sleep time by about 39.6 minutes compared to polysomnography (PSG), indicating it may not provide accurate sleep duration measurements for patients with hypersomnolence.

While the JB3 showed high sensitivity in detecting sleep (97%), it struggled to classify different sleep stages and failed to identify any sleep onset rapid eye movement periods (SOREMPs), making it unsuitable as a replacement for PSG or Multiple Sleep Latency Tests in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ability of the Multisensory Jawbone UP3 to Quantify and Classify Sleep in Patients With Suspected Central Disorders of Hypersomnolence: A Comparison Against Polysomnography and Actigraphy. Cook, JD., Prairie, ML., Plante, DT.[2019]

A novel at-home screening method for Obstructive Sleep Apnea (OSA) using a smartphone and a modified armband was developed and validated with 23 subjects, showing high sensitivity (92.3% to 100%) and accuracy (78.3% to 91.3%) for binary classifications of OSA severity.

This smartphone-based approach offers a promising alternative to the costly and time-consuming gold standard diagnostic procedure, Polysomnography (PSG), making OSA screening more accessible and efficient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Apnea Screening System for at-home Recording and Analysis of Sleep Apnea Severity. Bonnesen, MP., Sorensen, HBD., Jennum, P.[2020]

The Appnea-Q mobile app was found to be a feasible and well-accepted tool for managing obstructive sleep apnea (OSA) among patients, with 72-88% of users willing to recommend it and 64.87% believing it could reduce hospital visits.

Healthcare professionals also recognized the app's usefulness for patient follow-up, especially in the early stages of CPAP therapy, indicating its potential to enhance remote monitoring and support for OSA patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile health application to support CPAP therapy in obstructive sleep apnoea: design, feasibility and perspectives. Suarez-Giron, M., Garmendia, O., Lugo, V., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11136882/

SleepWell24, a Smartphone Application to Promote ...

SleepWell24 provides objective feedback on PAP usage and sleep/physical activity patterns, and chronic disease management. Patients were ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03156283

SleepWell24: An Innovative Smartphone Application to ...

The investigators will test the feasibility, acceptability, initial efficacy and outcomes of SleepWell24 compared to usual care during the first 60 days of PAP ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S155171441930624X

Rationale, design, and development of SleepWell24

This randomized controlled trial will evaluate the feasibility, acceptability, and initial efficacy of SleepWell24 compared to a usual care control condition ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8415005/

Rationale, Design, and Development of SleepWell24

This randomized controlled trial will evaluate the feasibility, acceptability, and initial efficacy of SleepWell24 compared to a usual care control condition ...

5.

withpower.com

withpower.com/trial/phase-obstructive-sleep-apnea-osa-4-2024-4bd30

App-Based Support for Obstructive Sleep Apnea

The SleepWell24 app was tested for its feasibility and acceptability in helping people stick to their sleep apnea treatment, but there is no specific safety ...