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NCT01831258 · ClinicalTrials.gov registry record · NA
Comparison Study of the ICON™ CPAP Series With and Without SensAwake™
A NA study, sponsored by Fisher and Paykel Healthcare.
- Completed
- Registry status
- NA
- Development phase
- 70
- Enrollment target
NCT01831258: Completed NA study, sponsored by Fisher and Paykel Healthcare.
NCT01831258 is a NA study that has completed, run by Fisher and Paykel Healthcare. The registered enrollment target is 70 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01831258, a NA study, has completed, sponsored by Fisher and Paykel Healthcare.
- COMPLETED
- Registry status
- NA
- Development phase
- 70 participants
- Enrollment target
Study Summary
Conceptually, awareness of pressure occurs only during wakefulness. Thus reducing the pressure during wakefulness may improve therapy comfort and potentially adherence without compromizing therapy efficacy. SensAwake™ is a unique pressure relief technology developed by Fisher \& Paykel Healthcare which detects irregularity in the flow signal indicative of the transition from sleep to wake. When the transition from sleep to wake is detected the device promptly reduces the pressure to help facilitate a return to sleep. The purpose of this study is to compare adherence and sleep quality outcomes in patients treated by CPAP with and without SensAwake technology. It is hypothesised that participants with SensAwake on will have improved adherence and sleep quality.
Primary Outcome
Average used minutes (all days) taken from the CPAP device.
Interventions
- DEVICE SensAwake On
- DEVICE SensAwake Off
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2013-03 |
| Est. Completion | 2014-09 |
| Phase | NA |
What the finished NCT01831258 record still lists
NCT01831258 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which SensAwake On is the first listed.
NCT01831258 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01831258 about?
NCT01831258 is a clinical study titled "Comparison Study of the ICON™ CPAP Series With and Without SensAwake™". Conceptually, awareness of pressure occurs only during wakefulness. Thus reducing the pressure during wakefulness may improve therapy comfort and potentially adherence without compromizing therapy efficacy. SensAwake™ is a unique pressure relief technology developed by Fisher \& Paykel Healthcare wh...
What is the current status of trial NCT01831258?
This trial is currently completed. It is a NA study. The enrollment target is 70 participants. The study started on 2013-03. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01831258?
The interventions under investigation include: SensAwake On (DEVICE), SensAwake Off (DEVICE).
Who is sponsoring clinical trial NCT01831258?
This trial is sponsored by Fisher and Paykel Healthcare, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01831258's enrollment target sits among peer trials
70 1103rd of 2000 higher than 868 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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