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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 is a NA study that has completed, run by Fisher and Paykel Healthcare. The registered enrollment target is 70 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01831258
The ClinicalTrials.gov registry entry for NCT01831258 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fisher and Paykel Healthcare, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which SensAwake On is the first listed.
NCT01831258 reports 0 study locations.
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.
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