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Clinical Trials/NCT01575210
NCT01575210
Completed
Not Applicable

Clinical Trial of a New Mask Vent, Designed to Reduce Noise of Mask Venting

ResMed1 site in 1 country31 target enrollmentJune 2012
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ConditionsObstructive Sleep Apnoea (OSA)

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstructive Sleep Apnoea (OSA)
Sponsor
ResMed
Enrollment
31
Locations
1
Primary Endpoint
The apnoea/hypopnoea index (AHI) will be recorded and analysed.
Status
Completed
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

As continuous positive airway pressure is the treatment of choice for OSA, a mask is vital in ensuring the effectiveness of therapy delivery. The study will evaluate the performance and usability of the new mask vent. This is done by comparing the apnea-hypopnea index (AHI) of patients, who will apply 2 different washing procedures to the new mask, at the end of the study and their baseline data obtained at the beginning of the study.The study will also assess the breathing comfort as well as obtaining subjective data on the usability of the new mask vent system.

Registry
clinicaltrials.gov
Start Date
June 2012
End Date
October 2012
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
ResMed
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Subjects who are using ResMed mask
  • •Subjects willing to provide written informed consent
  • •Subjects who have been treated for OSA \> 6 months
  • •Subjects who can read and comprehend English
  • •Subjects ≥ 18 years old
  • •Subjects who are using a ResMed S8 or S9 device

Exclusion Criteria

  • •Patients who are pregnant
  • •Patient on bi level treatment
  • •Patients being treated for OSA \< 6 months
  • •Patients who have a pre-existing lung disease/condition that would predispose them to pneumothorax (for example: COPD; lung cancer, fibrosis of the lungs; recent (\<2 years ago) case of pneumonia or lung infection; lung injury).
  • •Patients who are deemed unsuitable by the researcher due to the following reasons:
  • •They do not comprehend English
  • •They are unable to provide written informed consent
  • •They are physically unable to comply with the protocol

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • The level of comfort patients experience while using the new mask vent(12 weeks)
  • Patient's and bed partner's perceptions of the mask vent(12 weeks)

Study Sites (1)

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