SleepWell24: An Innovative Smartphone Application to Improve PAP Adherence

NCT ID: NCT03156283

Last Updated: 2019-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2019-08-01

Brief Summary

Obstructive sleep apnea (OSA) is a major public health concern n the United States. Positive airway pressure (PAP) therapy is the treatment-of-choice and "gold standard" for individuals with moderate-to-severe OSA. Regular and sustained PAP use can reduce risk for subsequent disease and improve quality of life. Nevertheless, PAP adherence rates are low. Most PAP adherence programs do not address the self-management skills and strategies that promote adherence and are often too costly and complex to integrate into overburdened clinical environments. Furthermore, they do not leverage opportunities to change lifestyle behaviors that occur across the 24h spectrum (i.e., sleep hygiene, sedentary behavior, physical activity), which have promise to improve OSA symptoms and PAP adherence. The investigators have previously developed and successfully tested BeWell24, a multicomponent smartphone "app" that uses evidence-based behavior change strategies to improve sleep, sedentary, and physical activity behaviors. The investigators will enhance this app to create SleepWell24. Enhancements will include: (1) specific behavior change strategies from the evidence-based Sleep Apnea Self-Management Program to promote PAP adherence; (2) an interface for exchange of patient data to facilitate patient-provider communication on treatment progress; and (3) real-time feedback via wireless integration with a consumer-based PAP machine and wearable sensor. All aspects of this work will be embedded within the Mayo Clinic Arizona Center for Sleep Medicine. The investigators will test the effects of SleepWell24 in newly prescribed PAP users and gather data on the feasibility and acceptability of using SleepWell24 compared to a usual care control group. The investigators will conduct a pilot randomized controlled trial with participants randomly assigned to (1) SleepWell24; or (2) usual care for 60 days post-PAP prescription. The investigators will track recruitment/retention rates, app usage statistics, and measures of treatment satisfaction. The investigators will objectively measure PAP adherence to test whether the SleepWell24 group will have more hours/night of PAP usage compared to the usual care group. In an exploratory fashion, the investigators will also examine the effect of SleepWell24 on selected treatment outcomes (weight, daytime sleepiness, cognitive impairment, and health-related quality of life) and evaluate social cognitive and lifestyle behavior mediators of SleepWell24 on PAP adherence.

Detailed Description

This exploratory study will test the feasibility and initial efficacy of a mobile health smartphone intervention to increase adherence to positive airway pressure (PAP) therapy in newly diagnosed obstructive sleep apnea (OSA) patients treated at the Mayo Clinic Arizona Center for Sleep Medicine and associated outpatient clinics. This app, called SleepWell24, will include PAP adherence behavior change strategies (drawn from the evidence-based Sleep Apnea Self-Management Program), cloud-based linkages to a consumer-based PAP machine and wearable sensor that provides nightly feedback on PAP adherence and sleep and activity metrics, and a component to enhance patient-provider communication. The investigators will embed SleepWell24 within usual patient care at the Mayo Clinic Arizona Center for Sleep Medicine and associated outpatient clinics for app design/development, patient recruitment, and treatment feasibility/satisfaction. This design will ensure the best opportunity for clinical adoption. The primary aims are:

Aim 1: Determine the feasibility and acceptability of SleepWell24 from patient and provider perspectives.

Aim 2: Determine the extent to which SleepWell24 improves PAP adherence over the first 60 days of use relative to usual care.

As an exploratory aim the investigators will explore the effect of SleepWell24 on treatment outcomes (weight, daytime sleepiness, cognitive performance, health-related quality of life) and putative social cognitive and behavioral mediators of PAP adherence (e.g., self-efficacy, sleep quality, sedentary behavior, physical activity).

The investigators will test the feasibility, acceptability, initial efficacy and outcomes of SleepWell24 compared to usual care during the first 60 days of PAP use among 94 patients newly diagnosed with obstructive sleep apnea.

Conditions

Obstructive Sleep Apnea of Adult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

SleepWell24 Application

A mobile health smartphone application based on evidence-based health behavior change theory and interventions to promote adherence to positive airway pressure therapy

Group Type: EXPERIMENTAL

SleepWell24 Application

Intervention Type: BEHAVIORAL

An evidence-based behavioral change smartphone application designed to promote adherence to positive airway pressure (PAP) therapy

Usual Care Plus Activity Monitor

Per usual clinical care standards within the Center for Sleep Medicine at Mayo Clinic Arizona, all patients will receive instructions/education on positive airway pressure (PAP) use, multiple mask fittings, encouragement to use PAP every night, and staff is available in the event of problems. Control patients will also receive a wearable activity monitor to use during the study. The wearable sensor will be used to isolate the effect of SleepWell24 on PAP adherence from potential novelty effects due to receiving a generic health behavior change app.

Group Type: OTHER

Usual Care Plus Activity Monitor

Intervention Type: OTHER

Participants will receive usual care at the Mayo Clinic Center for Sleep Medicine when first diagnosed with sleep apnea and prescribed positive airway pressure therapy. In addition, they will receive a commercial activity monitor with an associated smartphone application to isolate the effect of SleepWell24 on PAP adherence from potential novelty effects due to receiving a generic health behavior change app.

Interventions

SleepWell24 Application

An evidence-based behavioral change smartphone application designed to promote adherence to positive airway pressure (PAP) therapy

Intervention Type: BEHAVIORAL

Usual Care Plus Activity Monitor

Participants will receive usual care at the Mayo Clinic Center for Sleep Medicine when first diagnosed with sleep apnea and prescribed positive airway pressure therapy. In addition, they will receive a commercial activity monitor with an associated smartphone application to isolate the effect of SleepWell24 on PAP adherence from potential novelty effects due to receiving a generic health behavior change app.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Mild to severe obstructive sleep apnea diagnosed through clinical diagnostic testing and laboratory or home-based sleep study
• current use of appropriate Apple (iOS7 or higher) or Android (2.3 or higher) smartphone device
• Be able to read, write, and understand English
• Prescribed positive airway pressure therapy for obstructive sleep apnea

Exclusion Criteria

• Do not agree to be randomized
• Currently participating in other lifestyle change programs
• Personal, health, cognitive, or psychological conditions that prevent full participation
• Pregnant, lactating, or trying to become pregnant
• Prescribed high-dose benzodiazepines
• Daily opioid medication use at night
• Unwilling to discontinue use of any current wearable sensor for the duration of the trial
• Unwilling to consent for out-of-pocket costs
• Previous treatment/referral for claustrophobia
• Previous Positive airway pressure therapy use
• Planning to travel for more than seven consecutive nights during the trial
• Currently engaging in shiftwork

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: collaborator

Arizona State University

OTHER

Sponsor Role: lead

Responsible Party

Megan Petrov

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Megan E Petrov, PhD

Role: PRINCIPAL_INVESTIGATOR

Arizona State University

Matthew Buman, PhD

Role: PRINCIPAL_INVESTIGATOR

Arizona State University

Locations

Mayo Clinic

Scottsdale, Arizona, United States

Countries

United States

References

Petrov ME, Epstein DR, Krahn L, Todd M, Park JG, St Louis EK, Morgenthaler TI, Hoffmann CM, Hasanaj K, Hollingshead K, Yu TY, Buman MP. SleepWell24, a Smartphone Application to Promote Adherence to Positive Airway Pressure Therapy: Feasibility and Acceptability in a Randomized Controlled Trial. Behav Sleep Med. 2024 Jul-Aug;22(4):420-432. doi: 10.1080/15402002.2023.2289442. Epub 2023 Nov 30.

Reference Type: DERIVED

PMID: 38032115 (View on PubMed)

Other Identifiers

R21NR016046

Identifier Type: NIH

Identifier Source: secondary_id

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5R21NR016046-02

Identifier Type: NIH

Identifier Source: org_study_id

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