Post Market Clinical Follow up of ResMed Mask Systems
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: New generation CPAP mask.
- Who it may be relevant to
- Registry conditions: Obstructive Sleep Apnea. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
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.
Interventions
- Device New generation CPAP mask
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.
Primary outcome measures
- Apnea Hypopnea Index (event/hour) [Time frame: up to 90 days]
- Usage Hours (hours/night) [Time frame: up to 90 days]
- Leak (L/minute) [Time frame: up to 90 days]
- CPAP Pressure (cmH2O) [Time frame: up to 90 days]
- Adverse Events [Time frame: up to 90 days]
Secondary outcome measures (1)
- General Usability [Time frame: up to 90 days]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Australia · 1 center
- Medical Affairs ResMed — Sydney
Publications
- Zhu X, Benjafield A, Deas R, Willes L, Armitstead J. Feasibility and acceptability of switching from a previous-generation to a new-generation mask for positive airway pressure therapy of sleep apnea using remote care. Sleep Med X. 2024 Oct 11;8:100128. doi: 10.1016/j.sleepx.2024.100128. eCollection 2024 Dec 15. PMID 39498349
Identifiers
NCT: NCT05262439 · SLP-21-12-01