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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/NCT03752580




Registration number
NCT03752580
Ethics application status
Date submitted
20/11/2018
Date registered
26/11/2018
Date last updated
24/01/2019

Titles & IDs
Public title
An Investigation to Test a Prototype Nasal Mask in the Home Setting
Scientific title
An Investigation to Test a Prototype Nasal Mask in the Home Setting
Secondary ID [1] 0 0
CIA-240
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 - User Instructions of novel nasal mask

Experimental: Arm - Experimental: User Instructions of a Novel Nasal Mask Participants to interpret user instructions in a one hour daytime visit.


Treatment: Devices: User Instructions of novel nasal mask
User Unstructions interpretation of novel nasal mask for the treatment of obstructive sleep apnea (OSA).
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mask User Instructions Interpretation
Timepoint [1] 0 0
3 days

Eligibility
Key inclusion criteria
- OSA Mask Users

- 18+ years of age

- Ability to give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Inability to give informed consent

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
15/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/10/2018
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 a prospective non-blinded and non-randomized clinical investigation.
This investigation is to test the interpretation of user instructions of a prototype nasal
mask on participants. The clinical investigation will be conducted in New Zealand and
participants will interact with the user instructions in a one hour daytime visit. A minimum
of 15 participants will participate in this trial.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03752580
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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/NCT03752580