Back to resultsAssessment of the Performance of a New Reduced Noise Mask Vent
Primary Purpose
Obstructive Sleep Apnoea (OSA)
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
CPAP mask
CPAP mask
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnoea (OSA)
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
Sites / Locations
- ResMed Centre for Healthy Sleep
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A_ washing procedure 1
Group B_washing procedure 2
Arm Description
This group will apply washing technique 1.
This group will apply washing technique 2.
Outcomes
Primary Outcome Measures
The apnoea/hypopnoea index (AHI) will be recorded and analysed.
Breathing disruption events per hour of sleep will be measured and analysed
Secondary Outcome Measures
The level of comfort patients experience while using the new mask vent
Patients will complete a questionnaire regarding the noise of the new vent
Patient's and bed partner's perceptions of the mask vent
Patients partners will complete a questionnaire regarding the noise of the mask vent
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01575210
Brief Title
Assessment of the Performance of a New Reduced Noise Mask Vent
Official Title
Clinical Trial of a New Mask Vent, Designed to Reduce Noise of Mask Venting
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ResMed
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnoea (OSA)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A_ washing procedure 1
Arm Type
Experimental
Arm Description
This group will apply washing technique 1.
Arm Title
Group B_washing procedure 2
Arm Type
Experimental
Arm Description
This group will apply washing technique 2.
Intervention Type
Device
Intervention Name(s)
CPAP mask
Intervention Description
A new vent CPAP mask system will be used in this trial.
Intervention Type
Device
Intervention Name(s)
CPAP mask
Intervention Description
A new vent CPAP mask system will be used in this trial
Primary Outcome Measure Information:
Title
The apnoea/hypopnoea index (AHI) will be recorded and analysed.
Description
Breathing disruption events per hour of sleep will be measured and analysed
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
The level of comfort patients experience while using the new mask vent
Description
Patients will complete a questionnaire regarding the noise of the new vent
Time Frame
12 weeks
Title
Patient's and bed partner's perceptions of the mask vent
Description
Patients partners will complete a questionnaire regarding the noise of the mask vent
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Schindhelm, PhD
Organizational Affiliation
ResMed/ The University of New South Wales
Official's Role
Principal Investigator
Facility Information:
Facility Name
ResMed Centre for Healthy Sleep
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2153
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Assessment of the Performance of a New Reduced Noise Mask Vent
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