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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/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
Not Applicable
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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01575210
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01575210