SleepWell24: An Innovative Smartphone Application to Improve PAP Adherence
| Status: | Recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 1/16/2019 |
| Start Date: | November 1, 2017 |
| End Date: | July 31, 2019 |
| Contact: | Megan E Petrov, PhD |
| Email: | Megan.Petrov@asu.edu |
| Phone: | 602-496-2297 |
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.
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.
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.
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.
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
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