Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02851628




Registration number
NCT02851628
Ethics application status
Date submitted
28/07/2016
Date registered
1/08/2016
Date last updated
18/04/2018

Titles & IDs
Public title
The Evaluation of an Alternative Sizing Model in Comparison of a Conventional Sizing Model for Full Face Masks in the Treatment of OSA in Terms of Performance and Comfort
Scientific title
The Evaluation of an Alternative Sizing Model in Comparison of a Conventional Sizing Model for Full-face Masks in the Treatment of OSA in Terms of Performance and Comfort
Secondary ID [1] 0 0
CIA-194
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Disordered Breathing 0 0
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 - Alternative sizing model based trial mask
Treatment: Devices - Prototype Full Face Mask

Experimental: Alternative sizing model trial mask - In this arm participants who are randomized to the alternative sizing model based mask will be given the alternative sizing model based mask to use in home for the duration of this arm.

Active Comparator: Prototype Full Face Mask (PFFM) - In this arm, participants who are randomized to the PFFM will be given the PFFM to use in-home for the duration of this arm.


Treatment: Devices: Alternative sizing model based trial mask
A trial full face mask to be used for this trial for the treatment of obstructive sleep apnea using CPAP therapy.

Treatment: Devices: Prototype Full Face Mask
A prototype full face mask with previous clinical trial experience used for the treatment of obstructive sleep apnea using CPAP therapy.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Seal Comfort
Timepoint [1] 0 0
Up to 3 weeks in-home
Primary outcome [2] 0 0
Subjective Seal Leak
Timepoint [2] 0 0
Up to 3 weeks in-home
Primary outcome [3] 0 0
Objective Seal Leak
Timepoint [3] 0 0
Up to 3 weeks in-home
Secondary outcome [1] 0 0
Objective correct mask selection
Timepoint [1] 0 0
Up to 3 weeks in-home
Secondary outcome [2] 0 0
Subjective correct mask selection
Timepoint [2] 0 0
Up to 3 weeks in-home

Eligibility
Key inclusion criteria
- Adult (18+ years of age)

- Able to give consent

- Apnea Hypopnea Index (AHI) = 5 on diagnostic night

- Prescribed a Continuous Positive Airway Pressure (CPAP) device after successful OSA
diagnosis

- Existing nasal or full face mask user.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Inability to give consent

- Patients who are in a coma or a decreased level of consciousness.

- Anatomical or physiological conditions making APAP therapy inappropriate (e.g.
unconsolidated facial structure)

- Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)

- Current diagnosis of CO2 retention

- Pregnant or may think they are pregnant.

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
11/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/12/2017
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Hawkes Bay
Country [2] 0 0
New Zealand
State/province [2] 0 0
Waikato
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland
Country [4] 0 0
New Zealand
State/province [4] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The investigation is a prospective non-blinded and semi-randomized clinical investigation.
The investigation is designed to assess the alternative sizing model which the trial mask
concept is based on and how it compares to a conventional sizing present in the Prototype
Full Face Mask (PFFM) mask.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02851628
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kayan Gonda, BSc
Address 0 0
Sponsor Employee
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/NCT02851628