Back to resultsPost Market Clinical Follow up of ResMed Mask Systems
Primary Purpose
Obstructive Sleep Apnea
Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
New generation CPAP mask
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- 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
- Participants currently using a suitable mask system
- Participants currently using CPAP device compatible with AirView, or with download capacity from CPAP machine from data cards
Exclusion Criteria:
- 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
- Participants who or whose bed partner has implantable metallic implants in the head, neck and chest region affected by magnetic fields (Non-ferrous implants may be acceptable) (for masks with magnetic clips only)
Sites / Locations
- Medical Affairs ResMedRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
New generation CPAP mask
Arm Description
The intended purpose of mask systems is to provide airflow from a CPAP device, through tubing, and to the patient. The air acts as a pneumatic splint to keep the airway open and prevent collapse during sleep. The masks to be used in this study are released masks approved and released.
Outcomes
Primary Outcome Measures
Apnea Hypopnea Index (event/hour)
Apnea Hypopnea events per hour taken from the participant's CPAP device used during the study
Usage Hours (hours/night)
Average usage hours taken from the participant's CPAP device used during the study
Leak (L/minute)
Calculated leak from CPAP machine which assess how well mask seals on patients
CPAP Pressure (cmH2O)
Calculated average pressure from the CPAP machine which indicates how much pressure patients required to keep their airway open
Adverse Events
Device related adverse events during the study period will also be assessed.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05262439
Brief Title
Post Market Clinical Follow up of ResMed Mask Systems
Official Title
Post Market Clinical Follow up of ResMed Mask Systems
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2022 (Actual)
Primary Completion Date
June 2027 (Anticipated)
Study Completion Date
June 2027 (Anticipated)
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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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. .
Detailed Description
This is an open label, prospective, multi-centre, single arm study for post market clinical follow up. The study will be conducted in the home environment remotely. Eligible participants currently using older generations of CPAP masks will use the new generation ResMed mask system in the same mask category to their own (nasal, full face, pillow) in place of their own mask for 90 nights and complete a series of questionnaires at specified study checkpoints.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
New generation CPAP mask
Arm Type
Experimental
Arm Description
The intended purpose of mask systems is to provide airflow from a CPAP device, through tubing, and to the patient. The air acts as a pneumatic splint to keep the airway open and prevent collapse during sleep. The masks to be used in this study are released masks approved and released.
Intervention Type
Device
Intervention Name(s)
New generation CPAP mask
Intervention Description
All 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.
Primary Outcome Measure Information:
Title
Apnea Hypopnea Index (event/hour)
Description
Apnea Hypopnea events per hour taken from the participant's CPAP device used during the study
Time Frame
up to 90 days
Title
Usage Hours (hours/night)
Description
Average usage hours taken from the participant's CPAP device used during the study
Time Frame
up to 90 days
Title
Leak (L/minute)
Description
Calculated leak from CPAP machine which assess how well mask seals on patients
Time Frame
up to 90 days
Title
CPAP Pressure (cmH2O)
Description
Calculated average pressure from the CPAP machine which indicates how much pressure patients required to keep their airway open
Time Frame
up to 90 days
Title
Adverse Events
Description
Device related adverse events during the study period will also be assessed.
Time Frame
up to 90 days
Secondary Outcome Measure Information:
Title
General Usability
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Participants currently using a suitable mask system
Participants currently using CPAP device compatible with AirView, or with download capacity from CPAP machine from data cards
Exclusion Criteria:
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
Participants who or whose bed partner has implantable metallic implants in the head, neck and chest region affected by magnetic fields (Non-ferrous implants may be acceptable) (for masks with magnetic clips only)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xueling Zhu, BHSc (Nursing), RN
Phone
02 8884 2265
Email
Xueling.Zhu@resmed.com.au
First Name & Middle Initial & Last Name or Official Title & Degree
Ross Deas, PhD
Phone
02 8884 1703
Email
ross.deas@resmed.com.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Armistead, PhD
Organizational Affiliation
ResMed
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Affairs ResMed
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2153
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeff Armitstead, PhD
Phone
61488840000
12. IPD Sharing Statement
Learn more about this trial
Post Market Clinical Follow up of ResMed Mask Systems
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