Clinical trial NCT01831258: Comparison Study of the ICON™ CPAP Series With and Without SensAwake™
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2013-04-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Adherence to CPAP Treatment
timeFrame: 2 weeks
Secondary outcomes:
measure: Daytime Sleepiness (Subjective Sleep Quality)
timeFrame: 4 weeks
measure: Insomnia Severity Index (Subjective Sleep Quality)
timeFrame: 4 weeks
measure: OSA Impact of Daily Life
timeFrame: 4 weeks
measure: OSA Impact of Daily Life (Fatigue)
timeFrame: 4 weeks
measure: Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Severity
timeFrame: 4 weeks
measure: Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Change
timeFrame: 4 weeks
Other outcomes:
measure: Leak
timeFrame: One night
measure: Apnea Hypopnea Index (AHI)
timeFrame: 2 weeks
Locations:
city: Glendale
country: United States
facility: Pulmonary Associates
state: Arizona
city: Macon
country: United States
facility: SleepMed of Central Georgia
state: Georgia
city: Columbia
country: United States
facility: Sleep Med of South Carolina
state: South Carolina
Study officials:
References: