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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
Not applicable
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
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
1/03/2016
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