Assessment of the Performance of a New Reduced Noise Mask Vent

Study Overview
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Brief Summary
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As continuous positive airway pressure is the treatment of choice for OSA, a mask is vital in ensuring the effectiveness of therapy delivery. The study will evaluate the performance and usability of the new mask vent. This is done by comparing the apnea-hypopnea index (AHI) of patients, who will apply 2 different washing procedures to the new mask, at the end of the study and their baseline data obtained at the beginning of the study.The study will also assess the breathing comfort as well as obtaining subjective data on the usability of the new mask vent system.

Official Title
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Clinical Trial of a New Mask Vent, Designed to Reduce Noise of Mask Venting

Conditions
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Obstructive Sleep Apnoea (OSA)

Intervention / Treatment
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* Device: CPAP mask
* Device: CPAP mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who are using ResMed mask Subjects willing to provide written informed consent Subjects who have been treated for OSA > 6 months Subjects who can read and comprehend English Subjects ≥ 18 years old Subjects who are using a ResMed S8 or S9 device Exclusion Criteria: Patients who are pregnant Patient on bi level treatment Patients being treated for OSA < 6 months Patients who have a pre-existing lung disease/condition that would predispose them to pneumothorax (for example: COPD; lung cancer, fibrosis of the lungs; recent (<2 years ago) case of pneumonia or lung infection; lung injury). Patients who are deemed unsuitable by the researcher due to the following reasons: They do not comprehend English They are unable to provide written informed consent They are physically unable to comply with the protocol

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A_ washing procedure 1<br>This group will apply washing technique 1. | Device: CPAP mask<br>* A new vent CPAP mask system will be used in this trial.<br>|
| Experimental: Group B_washing procedure 2<br>This group will apply washing technique 2. | Device: CPAP mask<br>* A new vent CPAP mask system will be used in this trial<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The apnoea/hypopnoea index (AHI) will be recorded and analysed. | Breathing disruption events per hour of sleep will be measured and analysed | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The level of comfort patients experience while using the new mask vent | Patients will complete a questionnaire regarding the noise of the new vent | 12 weeks | 
| Patient's and bed partner's perceptions of the mask vent | Patients partners will complete a questionnaire regarding the noise of the mask vent | 12 weeks |