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

Stopped early · Not applicable

Conditions studied: Sleep Apnea, Obstructive

In brief

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).

Key facts

Study ID

NCT01517763

Run by

Fisher and Paykel Healthcare

People needed

32

Starts

2012-01-01

Expected to finish

2014-09-01

Last updated by the study team

2019-06-10

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Sleep HealthCenters — Brighton, Massachusetts, United States

Full record on ClinicalTrials.gov

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