Comparison of Auto-Adjusting Positive Airway Pressure Devices

Study Overview
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Brief Summary
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Little is understood about how different auto-adjusting PAP devices operate. The purpose of this evaluation is to compare two devices in a randomised two night PSG trial.

Official Title
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Comparison of Auto-Adjusting Positive Airway Pressure Devices

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: APAP A (ResMed AirSense AutoSet)
* Device: APAP B (Apex iCH Auto)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males aged ≥ 18 years Recently diagnosed with OSA (AHI ≥15). Recently defined as less than 3 months before study entry Naive to CPAP therapy Participants willing and able to give written informed consent Exclusion Criteria: Participants requiring Bi-level PAP Participants requiring supplemental oxygen Participants who are pregnant Subjects who have a pre existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 1) will use APAP A on the first night of the evaluation, and APAP B on the second night. | Device: APAP A (ResMed AirSense AutoSet)<br>* Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events<br>* Other names: Auto-Adjusting Positive Airway Pressure Device A;Device: APAP B (Apex iCH Auto)<br>* Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events<br>* Other names: Auto-Adjusting Positive Airway Pressure Device B;|
| Active Comparator: Group 2<br>Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 2) will use APAP B on the first night of the evaluation and APAP A on the second night. | Device: APAP A (ResMed AirSense AutoSet)<br>* Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events<br>* Other names: Auto-Adjusting Positive Airway Pressure Device A;Device: APAP B (Apex iCH Auto)<br>* Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events<br>* Other names: Auto-Adjusting Positive Airway Pressure Device B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Apnoea-Hypopnoea-Index (AHI) | AHI measures the number of apnoeas + hypopnoeas per hours of night (events/hour). | 1 night (446 minutes) for APAP A (AirSense), 1 night (436 minutes) for APAP B (Apex) | 
| Mean Oxygen Desaturation Index (ODI) | Number of times that Oxygen Level Drops by 3% below baseline value, Events/hour | 1 night (446 minutes) for APAP A, 1 night (436 minutes) for APAP B. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obstructive Apnoea Index (OAI) | Number of obstructive apnoeas per hour of nights sleep, Events/hour | 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B | 
| Central Apnoea Index (CAI) | Number of central apnoeas during hours of sleep, events/hour | 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B | 
| Mixed Apnoea Index (MAI) | Number of obstructive and central apnoeas per hours of nights sleep, Events/hour | 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B | 
| Hypopnoea-Index HI | Number of Hypopnoeas per hour of nights sleep, Events/hour | 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B | 
| Respiratory Effort Related Arousals RERAs | Number of RERAs per hour of nights sleep, Events/hour | 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B | 
| Flow Limitation (%) | Percent of flow-limited breaths in relation to the overall breaths at night. | 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B | 
| Mean O2 Saturation | Mean blood oxygen Saturation, % | 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B |