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

Trial Summary

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 data supports the effectiveness of the SleepWell24 Application treatment for obstructive sleep apnea?

Research shows that smartphone applications can help in the diagnosis, management, and follow-up of sleep disorders like obstructive sleep apnea, suggesting that app-based treatments like SleepWell24 may be effective in supporting patients. ^{1 2 3 4 5}

Is the SleepWell24 app safe for use in humans?

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 data mentioned in the research articles. ^{3 6 7 8 9}

How does the SleepWell24 Application treatment for obstructive sleep apnea differ from other treatments?

The SleepWell24 Application is unique because it uses smartphone technology to provide at-home support and monitoring for obstructive sleep apnea, making it more accessible and convenient compared to traditional treatments that often require in-person visits or expensive equipment. This app-based approach allows for remote management and self-monitoring, which can enhance patient engagement and adherence to treatment. ^{1 2 3 5 10}

What is the purpose of this trial?

The purpose of this study is to optimize the time of CPAP usage to at least 6 hours a night for 6 nights per week for people who have OSA with the help of a smartphone application called SmartWell24. This application aims to target CPAP adherence.

Research Team

Timothy Morgenthaler, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

References

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

Diagnostic value of smartphone in obstructive sleep apnea syndrome: A systematic review and meta-analysis. [2022]

2. Brazil pubmed.ncbi.nlm.nih.gov

A systematic review of smartphone applications and devices for obstructive sleep apnea. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Smartphone apps for snoring. [2015]

4. England pubmed.ncbi.nlm.nih.gov

Clinical validation of the Bedbugg in detection of obstructive sleep apnea. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Mobile health application to support CPAP therapy in obstructive sleep apnoea: design, feasibility and perspectives. [2022]

6. England pubmed.ncbi.nlm.nih.gov

SleepWell24, a Smartphone Application to Promote Adherence to Positive Airway Pressure Therapy: Feasibility and Acceptability in a Randomized Controlled Trial. [2023]

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

Snoring intensity assessment with three different smartphones using the SnoreLab application in one participant. [2021]

8. United States 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. [2019]

9. England pubmed.ncbi.nlm.nih.gov

The side-effects to CPAP treatment inventory: the development and initial validation of a new tool for the measurement of side-effects to CPAP treatment. [2015]

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

Mobile Apnea Screening System for at-home Recording and Analysis of Sleep Apnea Severity. [2020]