Clinical trial NCT03156283: SleepWell24: An Innovative Smartphone Application to Improve PAP Adherence
Official title: SleepWell24: An Innovative Smartphone Application to Improve PAP Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea of Adult
Keywords: smartphone
obstructive sleep apnea
adherence
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: Mayo Clinic
First posted: 2017-05-17
Enrollment: 119
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Recruitment and Retention
timeFrame: Duration of the trial (~60 days)
measure: SleepWell24 application usage
timeFrame: Duration of the trial (~60 days)
measure: Treatment acceptability/satisfaction
timeFrame: Baseline vs. Day 60 of trial
measure: Positive airway pressure therapy use
timeFrame: Duration of the trial (~60 days)
Secondary outcomes:
measure: Body Mass Index
timeFrame: Baseline and follow-up visit between days 31 and 60
measure: Daytime Sleepiness
timeFrame: Baseline, Day 30, Day 60 of trial
measure: Cognitive functioning
timeFrame: Baseline and follow-up visit between days 31 and 60
measure: Global Quality of Life due to physical and mental health via the Patient Reported Outcomes Measurement Information System Global Health Scale
timeFrame: Baseline, Day 30, Day 60 of trial
measure: Sleep Apnea-Specific Quality of Life
timeFrame: Baseline, Day 30, Day 60 of trial
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
Study officials:
affiliation: Arizona State University
name: Megan E Petrov, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Arizona State University
name: Matthew Buman, PhD
role: PRINCIPAL_INVESTIGATOR
References: