Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02297789




Registration number
NCT02297789
Ethics application status
Date submitted
19/11/2014
Date registered
21/11/2014
Date last updated
24/07/2015

Titles & IDs
Public title
Evaluation of a Full Face Mask and Headgear for the Treatment of Obstructive Sleep Apnea
Scientific title
Evaluation of a Full Face Mask and Headgear for the Treatment of Obstructive Sleep Apnea
Secondary ID [1] 0 0
CIA-152
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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
Experimental: Headgear 1 - Full Face Mask with Headgear 1

Experimental: Headgear 2 - Full Face Mask with Headgear 2
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The mask is comfortable and is effective for the participant during in-home use
Timepoint [1] 0 0
1 week for each mask prototype in-home
Secondary outcome [1] 0 0
Acceptability of the Full Face mask prototypes
Timepoint [1] 0 0
1 week for each mask prototype in-home

Eligibility
Key inclusion criteria
* AHI = 5 from the diagnostic night
* = 18 years of age
* Either prescribed APAP or CPAP or Bi level for OSA
* Existing full face users
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Inability to give informed consent
* Participant intolerance to PAP
* Anatomical or physiological conditions making PAP therapy inappropriate
* Current diagnosis of respiratory disease or CO2 retention
* Pregnant or think they may be 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
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
1/11/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2014
Sample size
Target
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
East Tamaki

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
Bhavi Ogra, BSc
Address 0 0
Fisher & Paykel Healthcare
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

No information has been provided regarding IPD availability


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/NCT02297789