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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/NCT02535234




Registration number
NCT02535234
Ethics application status
Date submitted
25/08/2015
Date registered
28/08/2015
Date last updated
4/02/2021

Titles & IDs
Public title
Comparison of Two Continuous Positive Airway Pressure Systems
Scientific title
Comparison of the Subjective and Objective Performance of a Novel Continuous Positive Airway Pressure (CPAP) System With a Traditional Continuous Positive Airway Pressure (CPAP) System.
Secondary ID [1] 0 0
MA011015
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 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 - Novel System
Treatment: Devices - Traditional System

Active Comparator: Arm 1 - Participants randomised to Arm 1 will receive an intervention of 7 nights with the Novel system followed by 7 nights with theTraditional system

Active Comparator: Arm 2 - Participants randomised to Arm 1 will receive an intervention of 7 nights with the Traditional system followed by 7 nights with the Novel system


Treatment: Devices: Novel System
A Novel full Continuous Positive Airway Pressure (CPAP) system - Prototype Device, Mask + Accessories

Treatment: Devices: Traditional System
A Traditional full Continuous Positive Airway Pressure (CPAP) system- Released Device + Accessories, Prototype Mask
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Subjective usability ratings of the prototype system using a visual analogue scale, compared to a reference level and the second full system.
Timepoint [1] 0 0
1 year

Eligibility
Key inclusion criteria
Inclusion Criteria

- Participant is willing to provide written informed consent

- Participant is able to read and comprehend written and spoken English

- Participant is = 18 years of age

- Participant has been diagnosed with Obstructive Sleep Apnoea (OSA)

- Participants has been established on Continuous Positive Airway Pressure (CPAP) for =
6 months

- Participants is currently using the same mask type/variant as the interventional mask
system to be evaluated

- Participants is able to participate for the duration of the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

- Participant is not willing to provide written informed consent

- Participant is unable to read and comprehend written and spoken English

- Participant is < 18 years of age

- Participant has not been diagnosed with Obstructive Sleep Apnoea (OSA)

- Participant has not been established on Continuous Positive Airway Pressure (CPAP) for
= 6 months

- Participant is not currently using the same mask type/variant as the interventional
mask system to be evaluated

- Participant is unable to participate for the duration of the study

- Participant is pregnant

- Participant is established on bi-level support therapy

- Participant, or participants bed partner, has metallic implants in head neck or chest

- Participant has a with a pre-existing lung disease or a condition that would
predispose them to pneumothorax (e.g. Chronic Obstructive Pulmonary Disease (COPD),
lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung
infection, lung injury)

- Participant is unsuitable to participate in the study in the opinion of the researcher

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
Crossover
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
1/04/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2016
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
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
Randomised crossover trial of a novel and traditional Continuous Positive Airway Pressure
(CPAP) system in Obstructive Sleep Apnoea patients.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02535234
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Klaus Schindhelm
Address 0 0
ResMed Limited
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/NCT02535234