Assessment of the Performance of a New Reduced Noise Mask Vent

February 26, 2021 updated by: ResMed

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2153
        • ResMed Centre for Healthy Sleep

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Device: CPAP mask
A new vent CPAP mask system will be used in this trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ResMed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ACTUAL)

October 1, 2012

Study Completion (ACTUAL)

October 1, 2012

Study Registration Dates

First Submitted

March 27, 2012

First Submitted That Met QC Criteria

April 9, 2012

First Posted (ESTIMATE)

April 11, 2012

Study Record Updates

Last Update Posted (ACTUAL)

March 1, 2021

Last Update Submitted That Met QC Criteria

February 26, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA210212

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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