Comparison Study of the ICON™ CPAP Series With and Without SensAwake™

Fisher & Paykel Healthcare

Status

Completed

Conditions

Obstructive Sleep Apnea

Treatments

Device: SensAwake On

Device: SensAwake Off

Study type

Interventional

Funder types

Industry

Identifiers

NCT01831258

FPH-SA13-01

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.