An observational study in Obstructive Sleep Apnea, sponsored by Fisher and Paykel Healthcare. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-03.
Sponsored by Fisher and Paykel Healthcare · Observational
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.
2,198 studies on the registry are indexed under Sleep Apnea, Obstructive; 469 are open to participants now.
This study's enrollment of 110 is close to the median of 104 across 648 observational studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Fisher and Paykel Healthcare is the lead sponsor of 84 studies on the registry; 15 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Any patient recieving CPAP for OSA.
Exclusion Criteria:
Other: Administration of the questionnaire and monitoring of CPAP adherence
CPAP Therapy Adherence
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.
Time frame: 90 days
| Milestone | CPAP Therapy |
|---|---|
| Started | 110 |
| Completed | 106 |
| Not completed | 4 |
| Withdrew: Physician decision | 1 |
| Withdrew: Withdrawal by subject | 3 |
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.
| participants | CPAP Therapy |
|---|---|
| CPAP Therapy Adherence | 103 |
Collected over Adverse event data was collected over 90 days for each participant.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CPAP Therapy | 0/110 (0%) | 0/110 (0%) | 0/110 (0%) |
| Age, Continuous(years) | CPAP Therapy |
|---|---|
| Mean | 51 (27 to 73) |
| Sex: Female, Male(Participants) | CPAP Therapy |
|---|---|
| Female | 43 |
| Male | 60 |
| Region of Enrollment(participants) | CPAP Therapy |
|---|---|
| United States | 103 |
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Fisher and Paykel Healthcare