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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/NCT03413098




Registration number
NCT03413098
Ethics application status
Date submitted
22/01/2018
Date registered
29/01/2018
Date last updated
22/03/2018

Titles & IDs
Public title
The Evaluation of a Novel Nasal Mask for the Treatment of Obstructive Sleep Apnea
Scientific title
The Evaluation of a Novel Nasal Mask for the Treatment of Obstructive Sleep Apnea
Secondary ID [1] 0 0
CIA233
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 - Nasal CPAP mask

Experimental: Trial nasal Continuous Positive Airway Pressure (CPAP) mask - Trial nasal CPAP mask


Treatment: Devices: Nasal CPAP mask
Investigative Nasal Mask to be used for OSA therapy
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Ease of use
Timepoint [1] 0 0
2 weeks
Primary outcome [2] 0 0
Acceptability
Timepoint [2] 0 0
2 weeks
Secondary outcome [1] 0 0
Objective leak data
Timepoint [1] 0 0
2 weeks

Eligibility
Key inclusion criteria
- Adult (18+ years of age)

- Able to give consent

- Apnea hypopnea Index (AHI)= 5 on diagnostic night

- Prescribed PAP for OSA

- Existing nasal 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 automatic positive airway pressure
(APAP) therapy inappropriate (e.g. unconsolidated facial structure)

- Commercial drivers who are investigated by New Zealand Transport Agency

- Current diagnosis of carbon dioxide (CO2) retention

- Pregnant or may think they are pregnant

Study design
Purpose of the study
Treatment
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
12/02/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/03/2018
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Hastings
Country [2] 0 0
New Zealand
State/province [2] 0 0
Wellington

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 a prospective, non randomized, non blinded study. This investigation is
designed to evaluate the performance, comfort and ease of use with the F&P trial nasal mask
amongst Obstructive Sleep Apnea (OSA) patients.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03413098
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sarah Gunson
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03413098