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

NCT ID: NCT01831258

Last Updated: 2017-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-09-30

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SensAwake On

The comfort feature 'SensAwake' will be turned on

Group Type: EXPERIMENTAL

SensAwake On

Intervention Type: DEVICE

SensAwake Off

The comfort feature 'SensAwake' will be turned off

Group Type: ACTIVE_COMPARATOR

SensAwake Off

Intervention Type: DEVICE

Interventions

SensAwake On

Intervention Type: DEVICE

SensAwake Off

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pulmonary Associates

Glendale, Arizona, United States

SleepMed of Central Georgia

Macon, Georgia, United States

Sleep Med of South Carolina

Columbia, South Carolina, United States

Countries

United States

Other Identifiers

FPH-SA13-01

Identifier Type: -

Identifier Source: org_study_id