Evaluation of Acclimate Feature for Positive Airway Pressure (PAP) Therapy

Study Overview
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Brief Summary
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The purpose of the study is to evaluate if using the Acclimate feature at the beginning of Positive Airway Pressure (PAP) therapy results in patients using their PAP therapy at least as long as they would standard therapy. Additionally, the Acclimate feature will be evaluated with regard to patient comfort, ease of acceptance of PAP therapy, leak events, and respiratory events.

Detailed Description
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Acclimate has been designed as a comfort feature for patients starting PAP therapy. The feature allows acclimatization to the targeted positive airway pressure setting. Using the Acclimate feature, the pressure increases incrementally over a period of time. The feature can be only be used for a set period of time, afterwards which the device initiates the therapeutic session at the prescribed pressure.

Official Title
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Evaluation of Positive Airway Pressure (PAP) Feature to Improve Patient Adherence to Therapy

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: S9 Elite with Acclimate
* Device: S9 Elite


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects ≥18 years of age. Recent diagnosis of moderate to severe OSA where fixed PAP is clinically indicated. Naïve to PAP therapy. Exclusion Criteria: Patients requiring supplemental oxygen. Patients with a history of pneumothorax, pneumomediastinum, cavities or cysts in the lung. Previous surgery to the brain, middle or inner ear, pituitary gland or sinuses. Middle ear infection or perforated ear drum. Ongoing sinus infection/sinusitis. Clinically significant epistaxis. Predominant central sleep apneas in the subject's PSG.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: Fixed Mode + Acclimate<br>S9 Elite flow generator with Acclimate feature activated. | Device: S9 Elite with Acclimate<br>* S9 Elite Flow Generator with Acclimate feature activated<br>|
| Active Comparator: Fixed Mode only<br>S9 Elite Flow Generator with Fixed Mode only | Device: S9 Elite<br>* S9 Elite Flow Generator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hours Used | The number of hours that each group used the device will be compared between subjects using fixed pressure with the Acclimate mode and subjects using fixed pressure without the Acclimate mode. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OSA, Sleep Apnea, PAP, positive airway pressure