Post Market Clinical Follow up of ResMed Mask Systems

Study Overview
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Brief Summary
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Post Market follow up study to systematically and proactively collect supplementary real world data to confirm the usability and performance of the new generation mask systems. .

Detailed Description
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This is an open label, prospective, multi-centre, single arm study for post market clinical follow up. The study will be conducted in the home environment remotely. Eligible participants currently using older generations of CPAP masks will use the new generation ResMed mask system in the same mask category to their own (nasal, full face, pillow) in place of their own mask for 90 nights and complete a series of questionnaires at specified study checkpoints.

Official Title
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Post Market Clinical Follow up of ResMed Mask Systems

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: New generation CPAP mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants willing to give written informed consent Participants who can read and comprehend English Participants who ≥ 18 years of age Participants being treated for OSA for ≥ 6 months Participants currently using a suitable mask system Participants currently using CPAP device compatible with AirView, or with download capacity from CPAP machine from data cards Exclusion Criteria: Participants using Bilevel flow generators Participants who are or may be pregnant Participants with 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. Participants believed to be unsuitable for inclusion by the researcher Participants who or whose bed partner has implantable metallic implants in the head, neck and chest region affected by magnetic fields (Non-ferrous implants may be acceptable) (for masks with magnetic clips only)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New generation CPAP mask<br>The intended purpose of mask systems is to provide airflow from a CPAP device, through tubing, and to the patient. The air acts as a pneumatic splint to keep the airway open and prevent collapse during sleep. The masks to be used in this study are released masks approved and released. | Device: New generation CPAP mask<br>* All participants entered into the study will be couriered a new generation ResMed mask system to be used with their own CPAP machine and in place of their own mask.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea Hypopnea Index (event/hour) | Apnea Hypopnea events per hour taken from the participant's CPAP device used during the study | up to 90 days | 
| Usage Hours (hours/night) | Average usage hours taken from the participant's CPAP device used during the study | up to 90 days | 
| Leak (L/minute) | Calculated leak from CPAP machine which assess how well mask seals on patients | up to 90 days | 
| CPAP Pressure (cmH2O) | Calculated average pressure from the CPAP machine which indicates how much pressure patients required to keep their airway open | up to 90 days | 
| Adverse Events | Device related adverse events during the study period will also be assessed. | up to 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General Usability | Subjective usability scores from participants. Each usability item of the new mask system will be rated on a Likert Scale questionnaire. A score of 10 is considered very favourable whereas score of 0 is considered very unfavourable. | up to 90 days |