Medical Affairs ResMed
Sydney, New South Wales, 2153, Australia
Location status: Recruiting
NCT Number: NCT05262439
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. .
Interested in participating?
Request Info18 year–100 year
All sexes
Interventional
Not applicable
Sydney, New South Wales, 2153, Australia
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: up to 90 days
Apnea Hypopnea events per hour taken from the participant's CPAP device used during the study
Time frame: up to 90 days
Average usage hours taken from the participant's CPAP device used during the study
Time frame: up to 90 days
Calculated leak from CPAP machine which assess how well mask seals on patients
Time frame: up to 90 days
Calculated average pressure from the CPAP machine which indicates how much pressure patients required to keep their airway open
Time frame: up to 90 days
Device related adverse events during the study period will also be assessed.
Time frame: up to 90 days
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.
Contact information is provided by the study sponsor or research team.
Ross Deas, PhD
CONTACT
Xueling Zhu, BHSc (Nursing), RN
CONTACT
ResMed
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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