Register a trial

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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/study/NCT02730273




Registration number
NCT02730273
Ethics application status
Date submitted
13/03/2016
Date registered
6/04/2016

Titles & IDs
Public title
The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea (OSA)
Scientific title
The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea (OSA)
Secondary ID [1] 0 0
CIA-184
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 - Trial Nasal mask

Experimental: Trial Nasal Mask - Participants to use nasal mask in-home for a week and one night in lab overnight polysomnography.


Treatment: Devices: Trial Nasal mask
Nasal mask for the treatment of obstructive sleep apnea (OSA)
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective leak data (L/min)
Timepoint [1] 0 0
Up to 1 week in-home
Primary outcome [2] 0 0
Subjective measurement of leak
Timepoint [2] 0 0
Up to 1 week in-home
Primary outcome [3] 0 0
Comfort
Timepoint [3] 0 0
Up to 1 week in-home
Primary outcome [4] 0 0
Stability
Timepoint [4] 0 0
Up to 1 week in-home
Primary outcome [5] 0 0
Draft
Timepoint [5] 0 0
Up to 1 week in-home
Primary outcome [6] 0 0
Noise
Timepoint [6] 0 0
Up to 1 week in-home
Primary outcome [7] 0 0
Objective leak data (L/min)
Timepoint [7] 0 0
1 night
Secondary outcome [1] 0 0
Preference of the mask
Timepoint [1] 0 0
Up to 1 week 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 nasal pillow 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
NA
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
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
1/03/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2016
Sample size
Target
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
For product development purposes only. Data will be deidentified.


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/NCT02730273