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NCT02230085 · ClinicalTrials.gov registry record
Adherence Risk Indicator Validation Study
A clinical trial, sponsored by Fisher and Paykel Healthcare.
- Completed
- Registry status
- 110
- Enrollment target
NCT02230085: Completed study, sponsored by Fisher and Paykel Healthcare.
NCT02230085 is a clinical trial that has completed, run by Fisher and Paykel Healthcare. The registered enrollment target is 110 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02230085 has completed, sponsored by Fisher and Paykel Healthcare.
- COMPLETED
- Registry status
- 110 participants
- Enrollment target
Study Summary
While continuous positive airway pressure (CPAP) is the gold standard treatment of obstructive sleep apnea (OSA), this therapy is often discontinued or not used optimally. The adherence risk indicator (ARI) is a statistical model based on answers from a questionnaire. The data collected from this trail allows for closer monitoring of at-risk patients. For the study, participants are provided with a questionnaire prior to starting CPAP therapy for OSA. Participants will be provided with a GSM (Global System for Mobile communication) modem to allow transmission of their CPAP data. Participants data will be retrieved at 7, 14, 21, 30 and 90 days to test the accuracy of the ARI prediction. At the conclusion of the study the GSM unit is returned, and participants continue with CPAP therapy as instructed by their healthcare provider.
Primary Outcome
Adherence is measured by the amount of CPAP use (e.g. good adherence was defined as use of greater than or equal to 70% of nights for greater than 4 hours per night). CPAP data was remotely collected and analyzed from the data reports generated by data collection.
Interventions
- OTHER Administration of the questionnaire and monitoring of CPAP adherence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2014-09 |
| Est. Completion | 2015-12 |
What the finished NCT02230085 record still lists
NCT02230085 is an observational study that tracks outcomes without assigning an intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Administration of the questionnaire and monitoring of CPAP adherence is the first listed.
NCT02230085 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02230085 about?
NCT02230085 is a clinical study titled "Adherence Risk Indicator Validation Study". While continuous positive airway pressure (CPAP) is the gold standard treatment of obstructive sleep apnea (OSA), this therapy is often discontinued or not used optimally. The adherence risk indicator (ARI) is a statistical model based on answers from a questionnaire. The data collected from this tr...
What is the current status of trial NCT02230085?
This trial is currently completed. The enrollment target is 110 participants. The study started on 2014-09. Estimated completion is 2015-12.
What interventions are being tested in trial NCT02230085?
The interventions under investigation include: Administration of the questionnaire and monitoring of CPAP adherence (OTHER).
Who is sponsoring clinical trial NCT02230085?
This trial is sponsored by Fisher and Paykel Healthcare, which has 25 total clinical trials registered on ClinicalTrials.gov.
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