Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01575210




Registration number
NCT01575210
Ethics application status
Date submitted
27/03/2012
Date registered
11/04/2012
Date last updated
1/03/2021

Titles & IDs
Public title
Assessment of the Performance of a New Reduced Noise Mask Vent
Scientific title
Clinical Trial of a New Mask Vent, Designed to Reduce Noise of Mask Venting
Secondary ID [1] 0 0
MA210212
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea (OSA) 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 - CPAP mask
Treatment: Devices - CPAP mask

Experimental: Group A_ washing procedure 1 - This group will apply washing technique 1.

Experimental: Group B_washing procedure 2 - This group will apply washing technique 2.


Treatment: Devices: CPAP mask
A new vent CPAP mask system will be used in this trial.

Treatment: Devices: CPAP mask
A new vent CPAP mask system will be used in this trial
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The apnoea/hypopnoea index (AHI) will be recorded and analysed.
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
The level of comfort patients experience while using the new mask vent
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Patient's and bed partner's perceptions of the mask vent
Timepoint [2] 0 0
12 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2012
Sample size
Target
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
ResMed Centre for Healthy Sleep - 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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Klaus Schindhelm, PhD
Address 0 0
ResMed/ The University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01575210