SleepWell24: An Innovative Smartphone Application to Improve PAP Adherence

NCT03156283 | Completed DMC

• 2 other identifiers: 5R21NR016046-02R21NR016046
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea of Adult

Keywords

smartphone; obstructive sleep apnea; adherence

Outcome Measures

Primary Outcomes (4)

• Recruitment and Retention

  numbers recruited and retained over the course of the trial

  Duration of the trial (~60 days)

• SleepWell24 application usage

  objective metrics of smartphone application usage by intervention group

  Duration of the trial (~60 days)

• Treatment acceptability/satisfaction

  Intervention acceptability questionnaire for both groups

  Baseline vs. Day 60 of trial

• Positive airway pressure therapy use

  How many hours per night therapy was used throughout the trial

  Duration of the trial (~60 days)

Secondary Outcomes (5)

• Body Mass Index

  Baseline and follow-up visit between days 31 and 60

• Daytime Sleepiness

  Baseline, Day 30, Day 60 of trial

• Cognitive functioning

  Baseline and follow-up visit between days 31 and 60

• Global Quality of Life due to physical and mental health via the Patient Reported Outcomes Measurement Information System Global Health Scale

  Baseline, Day 30, Day 60 of trial

• Sleep Apnea-Specific Quality of Life

  Baseline, Day 30, Day 60 of trial

Study Arms (2)

SleepWell24 Application

EXPERIMENTAL

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

Behavioral: SleepWell24 Application

Usual Care Plus Activity Monitor

OTHER

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.

Other: Usual Care Plus Activity Monitor

Interventions

SleepWell24 Application BEHAVIORAL

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

SleepWell24 Application

Usual Care Plus Activity Monitor 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.

Usual Care Plus Activity Monitor

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arizona State University: lead
• National Institute of Nursing Research (NINR): collaborator
• Mayo Clinic: collaborator

Study Sites (1)

Mayo Clinic

Scottsdale, Arizona, 85054, United States

Location

Related Publications (1)

• 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.

  PMID: 38032115 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies

Study Officials

• Megan E Petrov, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

• Matthew Buman, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 17, 2017
• Study Start: November 1, 2017
• Primary Completion: July 31, 2019
• Study Completion: August 1, 2019
• Last Updated: August 16, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)