Post Market Clinical Follow Up of ResMed Mask Systems
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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)
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- NA
Study ID
NCT05262439
Intervention or treatment
DEVICE: New generation CPAP mask
Conditions
- Obstructive Sleep Apnea
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Medical Affairs ResMed
Select from list below to view details:
Medical Affairs ResMed
Sydney, New South Wales, Australia
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Who is running the clinical trial?
ResMed
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: New generation CPAP mask
| Device: New generation CPAP mask |
What is the study measuring?
Primary Outcome
| 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
| 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 |
References
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