Modified AutoSet Device vs Existing AutoSet Device, the Assessment of Efficacy and Subjective Comfort of the Treatment.

Study Overview
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Brief Summary
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The purpose of this study is to determine if the performance of the modified AutoSet device is equivalent or better than the existing AutoSet device (VPAP Auto) in the efficacy of the treatment and the subjective comfort.

Detailed Description
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Obstructive sleep apnea (OSA) is characterised by a partial or complete collapse of the upper airway during sleep. The treatment of choice for OSA is Continuous Positive Airway Pressure (CPAP). CPAP acts as a positive airway splint, delivering a fixed or auto adjusted positive pressure to the upper airway via a tube and mask. The modified device to be assessed in this study will act in a similar way to the existing device, VPAP Auto, but utilizes an improved algorithm which should maintain or enhance the effectiveness of the treatment.

Official Title
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Comparison of the Efficacy and Subjective Comfort of a Modified AutoSet Device With an Existing AutoSet Device (VPAP Auto) in Treating Obstructive Sleep Apnea

Conditions
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Sleep Apnea

Intervention / Treatment
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* Device: Nexus Flow Generator
* Device: VPAP Flow Generator 25


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18-80 years Patients who are on CPAP therapy in AUTOSET mode for no less than 6 months Patients who are using ResMed masks Exclusion Criteria: Patients who are unable to provide written informed consent Patients who are unable to comprehend written and spoken English Patients who are using Bilevel PAP Patients who are pregnant Patients who are suffering any of the following: Acute respiratory infection Acute sinusitis, otitis media or perforated eardrum Pneumothorax or pneumomediastinum Recent history of severe epistaxis requiring medical attention

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nexus Flow Generator<br>Participants were randomised to Nexus Flow Generator group for one night. | Device: Nexus Flow Generator<br>* The modified device to be assessed in this study will act in a similar way to the existing device, VPAP Auto, but utilises an improved algorithm which should maintain or enhance the effectiveness of the treatment.<br>|
| Active Comparator: VPAP Flow Generator 25<br>Participants were randomised to VPAP Flow Generator 25 group for one night. | Device: VPAP Flow Generator 25<br>* Exiting VPAP Auto 25 Flow Generator with A10 Algorithm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnoea-Hypopnoea Index (AHI) | The number of apneas and hypopnoeas per hour of sleep measured on Nexus Auto & VPAP Auto 25 | One Night On Each Arm, approximately 8 hours each night | 
| Oxygen Desaturation Index | Number of oxygen desaturations per hour of sleep | One Night On Each Arm, approximately 8 hours each night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort of Breathing | Participant's Comfort Rating in one question: How comfortable/uncomfortable was the CPAP device to breathe on? Ratings from 0 (very uncomfortable) to 10 (very comfortable) on a Likert Scale | One Night On Each Arm, approximately 8 hours each night | 
| Satisfaction of Treatment | Participant's treatment satisfaction in one question: How much did the CPAP disturb your sleep last night? Rating from 0 (a lot) to 10 (not at all) on a Likert Scale | One Night On Each Arm, approximately 8 hours each night | 
| Refreshed Feel | Participants rated 0 (not refreshed at all) to 10 (very refreshed) on Likert Scale on one question: How refreshed did you feel this morning? | One Night On Each Arm, approximately 8 hours each night |