Comparison Study of the ICON™ CPAP Series With and Without SensAwake™
| Status: | Recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 11/8/2014 |
| Start Date: | March 2013 |
| Contact: | Patric Mercer |
| Email: | pmercer@sleepmedinc.com |
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.
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.
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.
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