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NCT03156283 · ClinicalTrials.gov registry record · NA
SleepWell24: An Innovative Smartphone Application to Improve PAP Adherence
A NA study, sponsored by Arizona State University.
- Completed
- Registry status
- NA
- Development phase
- 119
- Enrollment target
NCT03156283 is a NA study that has completed, run by Arizona State University. The registered enrollment target is 119 participants.
The verdict
NCT03156283, a NA study, has completed, sponsored by Arizona State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 119 participants
- Enrollment target
Study 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 st
Interventions
- BEHAVIORAL SleepWell24 Application
- OTHER Usual Care Plus Activity Monitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2017-11-01 |
| Est. Completion | 2019-08-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03156283
The ClinicalTrials.gov registry entry for NCT03156283 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 119 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Arizona State University, which has 187 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which SleepWell24 Application is the first listed.
NCT03156283 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03156283 about?
NCT03156283 is a clinical study titled "SleepWell24: An Innovative Smartphone Application to Improve PAP Adherence". 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 qual...
What is the current status of trial NCT03156283?
This trial is currently completed. It is a NA study. The enrollment target is 119 participants. The study started on 2017-11-01. Estimated completion is 2019-08-01.
What interventions are being tested in trial NCT03156283?
The interventions under investigation include: SleepWell24 Application (BEHAVIORAL), Usual Care Plus Activity Monitor (OTHER).
Who is sponsoring clinical trial NCT03156283?
This trial is sponsored by Arizona State University, which has 187 total clinical trials registered on ClinicalTrials.gov.
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