Post Market Clinical Follow up of ResMed Mask Systems
ConditionObstructive Sleep Apnea
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorResMed
About this trial
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. .
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
New generation CPAP mask
DeviceAll 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.
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: New generation CPAP maskExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Apnea Hypopnea Index (event/hour)
Apnea Hypopnea events per hour taken from the participant's CPAP device used during the study
Time frame
up to 90 days2
Usage Hours (hours/night)
Average usage hours taken from the participant's CPAP device used during the study
Time frame
up to 90 days3
Leak (L/minute)
Calculated leak from CPAP machine which assess how well mask seals on patients
Time frame
up to 90 days4
CPAP Pressure (cmH2O)
Calculated average pressure from the CPAP machine which indicates how much pressure patients required to keep their airway open
Time frame
up to 90 daysSecondary outcomes
1
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.
Time frame
up to 90 days Source ClinicalTrials.gov