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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/NCT02741635




Registration number
NCT02741635
Ethics application status
Date submitted
6/04/2016
Date registered
18/04/2016
Date last updated
15/05/2020

Titles & IDs
Public title
The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ
Scientific title
The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ
Secondary ID [1] 0 0
CIA-190
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 - New Nasal Pillows Mask

Experimental: New Nasal Pillows Mask - Participants to use nasal pillows mask one night in lab overnight polysomnography.


Treatment: Devices: New Nasal Pillows Mask
Nasal Pillows 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
First Initial Impressions of the Toffee Nasal Pillows Mask Assessed Using a Custom Questionnaire
Timepoint [1] 0 0
12 hours
Secondary outcome [1] 0 0
Comfort of the Toffee Nasal Pillows Mask Assessed Using a Custom Questionnaire
Timepoint [1] 0 0
12 hours
Secondary outcome [2] 0 0
Usability of the Toffee Nasal Pillows Mask Assessed With Visual Observations
Timepoint [2] 0 0
12 hours

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

- Able to give consent

- AHI = 5 on diagnostic night

- Prescribed a CPAP device after successful OSA diagnosis

- Existing nasal pillows 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 APAP therapy inappropriate

- Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)

- Current diagnosis of 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
1/04/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2016
Sample size
Target
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
East Tamaki

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 (leak and comfort) as well as the
participant's overall acceptance of the nasal pillows mask amongst Obstructive Sleep Apnea
(OSA) participants. Also to assist in the development process it would be beneficial to get
feedback from users on certain aspects of the design. The aim of this investigation is to get
feedback on the first impressions (look and feel) from users of nasal pillows PAP therapy.

A total number of 15 participants who currently use a nasal pillows mask will be recruited
for the trial. Participants from previous NZ trials may be recruited into this trial with
their consent. All the participants will be recruited from the Fisher & Paykel Healthcare
Database of subjects with OSA (Ethics Reference NTY/08/06/064), Auckland District Health
Board (ADHB) and New Zealand Respiratory and Sleep Institute (NZRSI).

Participants will undergo an overnight polysomnography session at the Fisher & Paykel
Healthcare sleep lab.

The participant will use the trial device on their usual Continuous or Auto Positive Airway
Pressure (CPAP/APAP) setting and device for the duration of the overnight in-lab study.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02741635
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bhavi Ogra, BSc
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