N/A
N=70
Comparison Study of the ICON™ CPAP Series With and Without SensAwake™
Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT01831258 ↗Enrolled (actual)
70
Serious AEs
0.7%
Results posted
Jul 2017
Primary outcome: Primary: Adherence to CPAP Treatment — 272.672; 289.087 mins
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SensAwake On (Device); SensAwake Off (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fisher and Paykel Healthcare
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adherence to CPAP Treatment |
272.672; 289.087 | — |
| SECONDARY Daytime Sleepiness (Subjective Sleep Quality) |
6.9; 6.4 | — |
| SECONDARY Insomnia Severity Index (Subjective Sleep Quality) |
7.8; 7.3 | — |
| SECONDARY OSA Impact of Daily Life |
32.7; 34.6 | — |
| SECONDARY OSA Impact of Daily Life (Fatigue) |
29.3; 28.2 | — |
| SECONDARY Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Severity |
4.3; 4.4 | — |
| SECONDARY Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Change |
4.2; 4.3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Aged 18-75 years with moderate-to-severe OSA (AHI equal to or greater than 10 per hour).
- Successful in-lab titration polysomnography (PSG)
- General (at home) sleep habits of:
- At least 7 hours in bed on most nights
- Lights out at 12 midnight or earlier
- Fluency in both written and spoken English.
Exclusion Criteria
- Participants prescribed and fitted with any PAP device in the past 2 years
- Contraindicated for CPAP or AutoCPAP therapy.
- Any known factor or disease that might interfere with treatment adherence, study conduct or interpretation of the results such as severe psychiatric disease, history of non adherence to medical regimens, or unwillingness to comply with study requirements as determined by the principal investigator.
- Other significant sleep disorder(s) that would interfere with their ability to wear CPAP as determined by the principal investigator.
- Patients who are prescribed hypnotics and sedating medications.
- Any surgery of the mouth, nose, sinuses or airways (for OSA, snoring or otherwise) in the past 12 months.
- If participants are required, by the nature of their employment, to comply with therapy. For example truck drivers or airline pilots.
- If the physician objects to their patient taking part in the study.
Data sourced from ClinicalTrials.gov (NCT01831258). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.