SleepWell24: An Innovative Smartphone Application to Improve PAP Adherence

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.

Conditions

• Obstructive Sleep Apnea of Adult

Interventions

BEHAVIORAL

SleepWell24 Application

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

OTHER

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.

Sponsors & Collaborators

• National Institute of Nursing Research (NINR)

  collaborator NIH

• Mayo Clinic

  collaborator OTHER

• Arizona State University

  lead OTHER

Principal Investigators

• Megan E Petrov, PhD · Arizona State University

• Matthew Buman, PhD · Arizona State University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-11-01

Primary Completion

2019-07-31

Completion

2019-08-01

Countries

• United States

Study Locations