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

Study Overview
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Brief Summary
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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).

Conditions
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Sleep Apnea, Obstructive

Intervention / Treatment
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* Device: Conventional CPAP Therapy
* Device: Fixed pressure ICON™ without ThermoSmart™
* Device: Auto ICON™ with SensAwake™ and ThermoSmart™


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Conventional CPAP<br>Fisher & Paykel HC244™ | Device: Conventional CPAP Therapy<br>* HC244 devices without Thermosmart or SensAwake<br>|
| Active Comparator: CPAP without Humidification<br>Fixed pressure ICON™ without ThermoSmart™ | Device: Fixed pressure ICON™ without ThermoSmart™<br>* Fixed pressure CPAP therapy using ICON™ without ThermoSmart™ or SensAwake™<br>|
| Experimental: APAP with all technologies<br>Auto ICON™ with SensAwake™ and ThermoSmart™ | Device: Auto ICON™ with SensAwake™ and ThermoSmart™<br>* APAP therapy using Auto ICON™ with SensAwake™ and ThermoSmart™<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence (Hours of Usage Per Night) and Acceptance (Number of Drop-outs). Complaints During Follow up Calls and Visit. |  | On day 90 after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive Sleep Apnea, Humidification, Continuous Positive Airway Pressure, ICON, ThermoSmart, SensAwake