Non-Inferiority Study of the FRESCA Airbox Positive Airway Pressure System

Study Overview
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Brief Summary
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Prospective, open-label, randomized crossover assignment, multi-center non-inferiority study conducted in the United States

Detailed Description
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This study is designed to demonstrate that the FRESCA Airbox Positive Airway Pressure System is non-inferior to the existing FRESCA Positive Airway Pressure System. Subjects meeting the inclusion and exclusion criteria will be randomized to one sleep night with the existing FRESCA device programmed to fixed pressure and one sleep night with the investigational FRESCA device programmed to auto-adjusting pressure and exhale pressure relief.

Official Title
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Non-Inferiority Study of the FRESCA Airbox Positive Airway Pressure System Versus the (Predicate) FRESCA Positive Airway Pressure System for the Treatment of Obstructive Sleep Apnea

Conditions
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Sleep Apnea

Intervention / Treatment
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* Device: positive airway pressure system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged 22 - 75 years old. BMI: ≤ 40 kg/m2. Subjects diagnosed with OSA (either newly diagnosed (naive) OSA subjects or current CPAP subjects). Must be able to be fitted properly with FRESCA mask. Must be able to comply with all study requirements as outlined in the protocol. Subject must complete a valid PSG titration night. Exclusion Criteria: Subjects with non-OSA sleep disorders (including periodic limb movement (PLM) disorder and chronic insomnia). Subjects with substantial central or mixed apneas (central and mixed apnea ≥ 5/hr.). Subjects with prior surgical intervention for OSA. Subjects with frequent or sustained episodes of O2 saturation ≤75%. Subjects with obesity-related hypoventilation. Subjects currently using a CPAP full face mask. Subjects who are medically unstable. Subjects with unstable or severe cardiovascular abnormalities (e.g., heart failure, valvular heart disease). Subjects with atrial fibrillation or other arrhythmias that are not effectively controlled with medication. Subjects with hypotension or uncontrolled HTN. Subjects with chronic lung disease, including COPD. Subjects with significant cardiopulmonary disease. Subjects with ongoing severe nasal allergies or sinusitis or difficulty breathing through the nose; persistent blockage of one or both nostrils; or any nasal or facial abnormalities that would not allow adequate placement and use of the mask. Subjects with surgery of the upper airway, nose, sinus or middle ear within the previous year. Subjects currently working nights, rotating night shifts or with planned travel during the study period. Subjects on a non-stable dose of medications or other agents that may affect sleep and/or PSG (e.g., sedatives or hypnotics). Subjects who consume > 500 mg caffeine per day (e.g., > 8 cola-type beverages, > 5 cups of coffee). Subjects who consume > 14 alcoholic drinks/week. Subjects who are pregnant (confirmed verbally). Subjects currently enrolled in any other research study.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 75 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: Crossover Assignment
Interventional Model Description: Prospective, open-label, randomized crossover assignment, multi-center study conducted in the United States
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sequence 1<br>FRESCA Airbox Flow Generator set to fixed pressure first, then FRESCA Airbox Generator set to auto-adjusting pressure. Second intervention within 1 - 10 days of first intervention. | Device: positive airway pressure system<br>* Positive Airway Pressure System<br>|
| Other: Sequence 2<br>FRESCA Airbox Flow Generator set to auto-adjusting pressure first, then FRESCA Airbox Generator set to fixed pressure. Second intervention within 1 - 10 days of first intervention. | Device: positive airway pressure system<br>* Positive Airway Pressure System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea-Hypopnea Index (AHI) | The mean combined number of apnea and hypopnea events per hour of sleep | 1 sleep night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen Desaturation Index (ODI) | The number of oxygen desaturations ≥ 4% per hour of sleep | 1 sleep night |