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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: Completed NA study, sponsored by Arizona State University.
NCT03156283 is a NA study that has completed, run by Arizona State University. The registered enrollment target is 119 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
numbers recruited and retained over the course of the trial
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 |
What the finished NCT03156283 record still lists
NCT03156283 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which SleepWell24 Application is the first listed.
NCT03156283 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03156283's enrollment target sits among peer trials
119 803rd of 2000 higher than 1,198 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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