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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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 - Subjective Questionnaire
Timepoint [1] 0 0
2 weeks
Primary outcome [2] 0 0
Acceptability - Subjective Questionnaire
Timepoint [2] 0 0
2 weeks
Secondary outcome [1] 0 0
Objective leak data - Data obtained from participant's device - Objective
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
Gender
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
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
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/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
Other publications