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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02942446




Registration number
NCT02942446
Ethics application status
Date submitted
11/10/2016
Date registered
24/10/2016
Date last updated
21/03/2019

Titles & IDs
Public title
Investigative Headgear With Nasal Pillows Continuous Positive Airway Pressure (CPAP) Mask
Scientific title
Investigative Headgear With Nasal Pillows CPAP Mask
Secondary ID [1] 0 0
CIA 150
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 - Investigative Headgear with CPAP mask

Experimental: Headgear - Investigative Headgear with CPAP mask


Treatment: Devices: Investigative Headgear with CPAP mask
Investigative Headgear with CPAP mask

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

Outcomes
Primary outcome [1] 0 0
Reliability of the headgear using a Questionnaire - Assessment of headgear properties on a monthly basis via custom questionnaire via phone call
Timepoint [1] 0 0
Monthly over a period of 6 months
Primary outcome [2] 0 0
Durability of the headgear by testing - Assessment of headgear properties on a monthly basis, and changes to the headgear
Timepoint [2] 0 0
Monthly over a period of 6 months
Secondary outcome [1] 0 0
Performance in regards to leak of the headgear - Objective Leak Data (L/min) from the device download
Timepoint [1] 0 0
Monthly over a period of 6 months
Secondary outcome [2] 0 0
Performance in regards to comfort of the headgear - Custom Questionnaire
Timepoint [2] 0 0
Monthly over a period of 6 months

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

- =18 years of age

- Prescribed CPAP or Bi-level therapy for OSA

- Existing F&P Pilairo Q, Eson, Simplus mask users
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Inability to give informed consent

- Patient intolerant to CPAP

- Anatomical or physiological conditions making CPAP therapy inappropriate

- History of respiratory disease or carbon dioxide (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 6 months.
Trial website
https://clinicaltrials.gov/show/NCT02942446
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sarah Gunson, BSc
Address 0 0
Clinical Research Associate
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