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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03092921




Registration number
NCT03092921
Ethics application status
Date submitted
22/03/2017
Date registered
28/03/2017

Titles & IDs
Public title
The Evaluation of a Mask Seal/Mask for the Treatment of Obstructive Sleep Apnea (OSA)
Scientific title
The Evaluation of a Mask for the Treatment of Obstructive Sleep Apnea (OSA)
Secondary ID [1] 0 0
CIA-209
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Disordered Breathing 0 0
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 - F&P Mask Seal
Treatment: Devices - F&P Mask

Experimental: F&P Mask Seal - Participants to use trial seal in-home for 1 week

Experimental: F&P Mask - Participants to use trial mask in-home for 2 weeks


Treatment: Devices: F&P Mask Seal
Investigative Mask Seal to be used for OSA therapy

Treatment: Devices: F&P Mask
Investigative 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
1 week in home
Primary outcome [2] 0 0
Acceptability
Timepoint [2] 0 0
1 week in home
Primary outcome [3] 0 0
Ease of use
Timepoint [3] 0 0
2 weeks in home
Primary outcome [4] 0 0
Acceptability
Timepoint [4] 0 0
2 weeks in home
Secondary outcome [1] 0 0
Objective leak data
Timepoint [1] 0 0
1 week in home

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 oro-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
Non-randomised trial
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
27/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/08/2017
Sample size
Target
Accrual to date
Final
18
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sarah Gunson
Address 0 0
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
For product development purposes only. Data will be deidentified.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03092921