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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02730273




Registration number
NCT02730273
Ethics application status
Date submitted
13/03/2016
Date registered
6/04/2016
Date last updated
17/07/2017

Titles & IDs
Public title
The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea (OSA)
Scientific title
The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea (OSA)
Secondary ID [1] 0 0
CIA-184
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 - Trial Nasal mask

Experimental: Trial Nasal Mask - Participants to use nasal mask in-home for a week and one night in lab overnight polysomnography.


Treatment: Devices: Trial Nasal mask
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
Objective leak data (L/min) - Obtained from the participant's device
Timepoint [1] 0 0
Up to 1 week in-home
Primary outcome [2] 0 0
Subjective measurement of leak - Subjective Questionnaire
Timepoint [2] 0 0
Up to 1 week in-home
Primary outcome [3] 0 0
Comfort - Subjective Questionnaire
Timepoint [3] 0 0
Up to 1 week in-home
Primary outcome [4] 0 0
Stability - Subjective Questionnaire
Timepoint [4] 0 0
Up to 1 week in-home
Primary outcome [5] 0 0
Draft - Subjective Questionnaire
Timepoint [5] 0 0
Up to 1 week in-home
Primary outcome [6] 0 0
Noise - Subjective Questionnaire
Timepoint [6] 0 0
Up to 1 week in-home
Primary outcome [7] 0 0
Objective leak data (L/min) - Obtained from the overnight polysomnography
Timepoint [7] 0 0
1 night
Secondary outcome [1] 0 0
Preference of the mask - Subjective Questionnaire
Timepoint [1] 0 0
Up to 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 a Continuous Positive Airway Pressure (CPAP) device after successful OSA
diagnosis

- Existing nasal or nasal pillow 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 APAP therapy inappropriate (e.g.
unconsolidated facial structure)

- 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
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
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 (leak and comfort) as well as the
participant's overall acceptance of the trial nasal mask amongst Obstructive Sleep Apnea
(OSA) participants. An important factor in this investigation will be the testing of two
different seal sizes on the participants (medium and large size). A total number of 12
participants who currently use nasal or nasal pillow masks will be recruited for the trial.
Participants have been selected based on their anthropometric measurements collected in
previous trials (CIA-103). 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 use the trial mask in home for a period of 7 ± 3 days and also 1 overnight
polysomnography session at the Fisher & Paykel Healthcare sleep lab. Baseline data will be
collected from the participant during the first visit, 7 days of CPAP usage data will be
downloaded and stored for analysis. 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 trial.
Trial website
https://clinicaltrials.gov/show/NCT02730273
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kayan Gonda, 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

Summary results
Other publications