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

Not Applicable

Completed

Conditions: Obstructive Sleep Apnea

Interventions: Device: SensAwake On
Device: SensAwake Off

Registration Number: NCT01831258

Lead Sponsor: Fisher and Paykel Healthcare

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 70

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SensAwake On	SensAwake On	The comfort feature 'SensAwake' will be turned on
SensAwake Off	SensAwake Off	The comfort feature 'SensAwake' will be turned off

Primary Outcome Measures

Name	Time	Method
Adherence to CPAP Treatment	2 weeks	Average used minutes (all days) taken from the CPAP device.

Secondary Outcome Measures

Name	Time	Method
OSA Impact of Daily Life	4 weeks	Collected through the Short Functional Outcomes of Sleep Questionnaire (FOSQ-10). The questionnaire has 10 questions which ask how daytime sleepiness has impacted their quality of life. Each question has a scale of 1 = yes extreme to 4 = No. Lower total score (min 10) means that the disease is affecting your quality of life while a higher total score (maximum 40) means that the disease is not affecting your quality of life.
OSA Impact of Daily Life (Fatigue)	4 weeks	Collected through the Fatigue Severity Scale (FSS). There are 9 question on fatigue with each question having a scale of 1 = strongly disagree and 7 = strongly agree. A lower total score (minimum of 9) = low severity with fatigue while a higher total score (maximum of 63) indicates a higher severity with fatigue.
Daytime Sleepiness (Subjective Sleep Quality)	4 weeks	Collected through the Epworth Sleepiness Scale (ESS) which is a subjective questionnaire and the participant answer 8 question with rating on the chance of dozing (from 0= no chance of dozing to 3 = high chance of dozing). The total is added with a range from 0-24. A total score of 0 means that the participant is not experiencing day time sleepiness, while total score of 24 means that the participant si extremely sleepy during the daytime.
Insomnia Severity Index (Subjective Sleep Quality)	4 weeks	Collected through the Insomnia Severity Index (ISI). There are seven question with each question having a scale of 0 (no issue) to 4 (very severe). The total score is added up. If the participant has a total score of 0-7 = no clinical significant insomnia, total score of 8-14 = sub threshold insomnia, total score of 15-21 = clinical insomnia (moderate), total score of 22-28 = clinical insomnia (severe).
Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Change	4 weeks	Collected through the Patient Global Impression of Change (PGI).The questions ask "Since beginning CPAP therapy, how would you describe the change (if any) in overall quality of life related to your OSA?". The questions has a scale of 1 = no change (or condition has got worse) to 7 = a great deal better and a considerable improvement that has made all the difference.
Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Severity	4 weeks	Collected through the Patient Global Impression of Change (PGI).The questions ask "Since beginning CPAP therapy, how would you describe the chance (if any) in symptoms related to your OSA. The questions has a scale of 1 = no change (or condition has got worse) to 7 = a great deal better and a considerable improvement that has made all the difference.

Trial Locations

Locations (3): SleepMed of Central Georgia
🇺🇸
Macon, Georgia, United States
Sleep Med of South Carolina
🇺🇸
Columbia, South Carolina, United States
Pulmonary Associates
🇺🇸
Glendale, Arizona, United States