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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05262439




Registration number
NCT05262439
Ethics application status
Date submitted
3/02/2022
Date registered
2/03/2022
Date last updated
14/12/2022

Titles & IDs
Public title
Post Market Clinical Follow up of ResMed Mask Systems
Scientific title
Post Market Clinical Follow up of ResMed Mask Systems
Secondary ID [1] 0 0
SLP-21-12-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - New generation CPAP mask

Experimental: New generation CPAP mask - 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.


Treatment: Devices: New generation CPAP mask
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Apnea Hypopnea Index (event/hour)
Timepoint [1] 0 0
up to 90 days
Primary outcome [2] 0 0
Usage Hours (hours/night)
Timepoint [2] 0 0
up to 90 days
Primary outcome [3] 0 0
Leak (L/minute)
Timepoint [3] 0 0
up to 90 days
Primary outcome [4] 0 0
CPAP Pressure (cmH2O)
Timepoint [4] 0 0
up to 90 days
Primary outcome [5] 0 0
Adverse Events
Timepoint [5] 0 0
up to 90 days
Secondary outcome [1] 0 0
General Usability
Timepoint [1] 0 0
up to 90 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2027
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Medical Affairs ResMed - Sydney
Recruitment postcode(s) [1] 0 0
2153 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ResMed
Address
Country

Ethics approval
Ethics application status

Summary
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. .
Trial website
https://clinicaltrials.gov/ct2/show/NCT05262439
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jeff Armistead, PhD
Address 0 0
ResMed
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Xueling Zhu, BHSc (Nursing), RN
Address 0 0
Country 0 0
Phone 0 0
02 8884 2265
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05262439