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Recruiting Not applicable NCT05262439

Post Market Clinical Follow Up of ResMed Mask Systems

No applicable phase (e.g. observational)
Conditions: Obstructive Sleep Apnea

Sponsor: ResMed

trial.available_in: БГ
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. .
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.
Who can participate
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)
Locations 1
Australia (1)
Medical Affairs ResMed
Sydney , New South Wales
Jeff Armitstead, PhD
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
100 Years
Healthy volunteers
No
Start date
26.05.2022
Completion date
01.06.2027
Registry ID
NCT05262439
Source
anzctr
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