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

Fisher & Paykel Healthcare

Status: Terminated

Conditions: Sleep Apnea, Obstructive

Treatments: Device: Fixed pressure ICON™ without ThermoSmart™; Device: Auto ICON™ with SensAwake™ and ThermoSmart™; Device: Conventional CPAP Therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01517763

FPH-SA09-01

Details and patient eligibility

About

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).

Enrollment: 32 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 3 patient groups, including a placebo group

Conventional CPAP

Placebo Comparator group

Description:

Fisher \& Paykel HC244™

Treatment:

Device: Conventional CPAP Therapy

CPAP without Humidification

Active Comparator group

Description:

Fixed pressure ICON™ without ThermoSmart™

Treatment:

Device: Fixed pressure ICON™ without ThermoSmart™

APAP with all technologies

Experimental group

Description:

Auto ICON™ with SensAwake™ and ThermoSmart™

Treatment:

Device: Auto ICON™ with SensAwake™ and ThermoSmart™