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

Obstructive Sleep Apnea Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01831258
• Other study ID #: FPH-SA13-01
• Status: Completed
• Phase: N/A
• First received: April 2, 2013
• Last updated: October 14, 2014
• Start date: March 2013
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Device:
• SensAwake On

• SensAwake Off

Locations

Country	Name	City	State
United States	Sleep Med of South Carolina	Columbia	South Carolina
United States	Pulmonary Associates	Glendale	Arizona
United States	SleepMed of Central Georgia	Macon	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to CPAP treatment	Use of CPAP device in hours/night, objective measurement from the CPAP device	4 weeks	No
Secondary	Sleep Quality - objective	Objectively measured during overnight polysomnography in the sleep lab.	One night	No
Secondary	Sleep Quality - Subjective	Measured subjectively by sleep diary	4 weeks	No