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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Timepoint [1] 0 0
Monthly over a period of 6 months
Primary outcome [2] 0 0
Durability of the headgear by testing
Timepoint [2] 0 0
Monthly over a period of 6 months
Secondary outcome [1] 0 0
Performance in regards to leak of the headgear
Timepoint [1] 0 0
Monthly over a period of 6 months
Secondary outcome [2] 0 0
Performance in regards to comfort of the headgear
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
Sex
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
N/A
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
1/10/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2017
Sample size
Target
Accrual to date
Final
20
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02942446