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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02323035




Registration number
NCT02323035
Ethics application status
Date submitted
15/12/2014
Date registered
23/12/2014
Date last updated
18/04/2019

Titles & IDs
Public title
Investigative Headgear With CPAP Mask
Scientific title
Investigative Headgear With CPAP Mask
Secondary ID [1] 0 0
CIA150
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
Treatment: Devices - Headgear

Experimental: Headgear - Investigative Headgear with CPAP Mask.


Treatment: Devices: Headgear
Investigative Headgear with CPAP Mask.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Participants perception of the headgear on mask performance - Assess if the headgear with mask changes the perception of the performance of the mask.
Timepoint [1] 0 0
2-4 weeks
Secondary outcome [1] 0 0
Number of participants that choose this Headgear over their usual. - Assess the acceptability of the headgear with mask.
Timepoint [1] 0 0
2-4 weeks

Eligibility
Key inclusion criteria
- AHI=5 from the diagnostic night

- =18 years of age

- Prescribed CPAP or Bilevel therapy for OSA

- Existing CPAP mask users
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Inability to give informed consent

- Patient intolerant to PAP

- Anatomical or physiological conditions making PAP therapy inappropriate

- History of respiratory disease or CO2 retention.

- Pregnant or think they may be pregnant

- Investigated by Land Transport Safety Authority

Study design
Purpose of the study
Other
Allocation to intervention
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
This investigation is designed to evaluate the at-home usability, performance, user
acceptance and reliability of the Headgear with a CPAP Mask for a duration of 2-4 weeks.
Trial website
https://clinicaltrials.gov/show/NCT02323035
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bhavi Ogra, BSc
Address 0 0
Clinical Research Scientist
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
Other publications