Trial Review

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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/NCT03092921




Registration number
NCT03092921
Ethics application status
Date submitted
22/03/2017
Date registered
28/03/2017
Date last updated
8/08/2017

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
This investigation is designed to evaluate the performance as well as the patients overall
acceptance of the seal/mask.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03092921
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03092921