Assessment of the Performance of a New Reduced Noise Mask Vent
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|ClinicalTrials.gov Identifier: NCT01575210|
Recruitment Status : Completed
First Posted : April 11, 2012
Last Update Posted : March 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnoea (OSA)||Device: CPAP mask||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Trial of a New Mask Vent, Designed to Reduce Noise of Mask Venting|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
Experimental: Group A_ washing procedure 1
This group will apply washing technique 1.
Device: CPAP mask
A new vent CPAP mask system will be used in this trial.
Experimental: Group B_washing procedure 2
This group will apply washing technique 2.
Device: CPAP mask
A new vent CPAP mask system will be used in this trial
- The apnoea/hypopnoea index (AHI) will be recorded and analysed. [ Time Frame: 12 weeks ]Breathing disruption events per hour of sleep will be measured and analysed
- The level of comfort patients experience while using the new mask vent [ Time Frame: 12 weeks ]Patients will complete a questionnaire regarding the noise of the new vent
- Patient's and bed partner's perceptions of the mask vent [ Time Frame: 12 weeks ]Patients partners will complete a questionnaire regarding the noise of the mask vent
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575210
|Australia, New South Wales|
|ResMed Centre for Healthy Sleep|
|Sydney, New South Wales, Australia, 2153|
|Principal Investigator:||Klaus Schindhelm, PhD||ResMed/ The University of New South Wales|