Comparison Study of the ICON™ Auto Series With and Without SensAwake™ and ThermoSmart™ and Conventional Continuous Positive Airway Pressure in Obstructive Sleep Apnea Patients

Not Applicable

Terminated

• Conditions: Sleep Apnea, Obstructive
• Interventions: Device: Fixed pressure ICON™ without ThermoSmart™; Device: Auto ICON™ with SensAwake™ and ThermoSmart™; Device: Conventional CPAP Therapy

• Registration Number: NCT01517763
• Lead Sponsor: Fisher and Paykel Healthcare

Brief Summary

A total of 216 patients will be randomized into a partially single blind, randomized, parallel-arm trial to determine whether the ICON™ AT with SensAwake™ and ThermoSmart™ can improve therapy adherence when compared to standard care with a fixed pressure Continuous Positive Airway Pressure (CPAP) device and compared to a less aesthetically pleasing CPAP device without technologies (AutoCPAP, SensAwake™, ThermoSmart™) in patients previously diagnosed with moderate-severe obstructive sleep apnea (OSA).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-17
• Study First Submitted QC: 2012-01-22
• Study First Posted: 2012-01-25
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2019-05
• Results First Submitted: 2019-05-19
• Results First Submitted QC: 2019-05-19
• Last Update Submitted: 2019-05-19
• Results First Posted: 2019-06-10
• Last Update Posted: 2019-06-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Aged 18-70 years with moderate-to-severe OSA (Apnea Hypopnea Index equal to or greater than 10 per hour).
• Successful titration Polysomnography (PSG).
• 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.
• Previous surgery for OSA or snoring or any surgery of the mouth, nose, sinuses or airways.
• If SensAwake™ or ThermoSmart™ was disabled on the treatment arm (or conversely) during the study protocol.
• 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: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPAP without Humidification	Fixed pressure ICON™ without ThermoSmart™	Fixed pressure ICON™ without ThermoSmart™
APAP with all technologies	Auto ICON™ with SensAwake™ and ThermoSmart™	Auto ICON™ with SensAwake™ and ThermoSmart™
Conventional CPAP	Conventional CPAP Therapy	Fisher \& Paykel HC244™

Primary Outcome Measures

Name	Time	Method
Adherence With Treatment Per Night Averaged Over Total Time Period Measured Via Internal Software on the Device and Reported on Using InfoSmart™ Software.	On day 90 after randomization

Secondary Outcome Measures

Name	Time	Method
Adherence (Hours of Usage Per Night) and Acceptance (Number of Drop-outs). Complaints During Follow up Calls and Visit.	On day 90 after randomization

Trial Locations

Locations (1)

Sleep HealthCenters; 🇺🇸 Brighton, Massachusetts, United States