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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/NCT03075722




Registration number
NCT03075722
Ethics application status
Date submitted
5/03/2017
Date registered
9/03/2017
Date last updated
20/04/2017

Titles & IDs
Public title
The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea (OSA): Comfort & Performance Trial
Scientific title
The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea (OSA): Comfort & Performance Trial
Secondary ID [1] 0 0
CIA-205
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 - Saturn nasal mask

Experimental: Saturn nasal mask - Participants to use nasal mask in-home for 7 ± 3 days


Treatment: Devices: Saturn 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
Comfort
Timepoint [1] 0 0
Up to 7 ± 3 days in-home
Primary outcome [2] 0 0
Stability
Timepoint [2] 0 0
Up to 7 ± 3 days in-home
Primary outcome [3] 0 0
Objective leak data
Timepoint [3] 0 0
Up to 7 ± 3 days in-home
Primary outcome [4] 0 0
Subjective measurement of leak
Timepoint [4] 0 0
Up to 7 ± 3 days in-home
Primary outcome [5] 0 0
Draft
Timepoint [5] 0 0
Up to 7 ± 3 days in-home
Primary outcome [6] 0 0
Treatment efficacy
Timepoint [6] 0 0
Up to 7 ± 3 days in-home
Primary outcome [7] 0 0
Noise
Timepoint [7] 0 0
Up to 7 ± 3 days in-home
Secondary outcome [1] 0 0
Preference of mask
Timepoint [1] 0 0
Up to 7 ± 3 days in-home
Secondary outcome [2] 0 0
Usability
Timepoint [2] 0 0
Up to 7 ± 3 days in-home

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 or nasal pillow 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

- Participants 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
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
9/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/04/2017
Sample size
Target
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Wellington

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 (treatment and leak), comfort
(subjective feedback), stability (subjective feedback, leak) as well as the participant's
overall acceptance of the Saturn mask amongst OSA participants. An important factor in this
investigation will be the testing of our two different seal sizes on the participants (small
and medium size). A total number of 15 participants who currently use nasal or nasal pillow
masks will be recruited for the trial. A subset of participants have been selected based on
their anthropometric measurements collected in previous trials using nasal and nasal pillow
masks at this site (CIA-103). Participants from previous NZ trials may be recruited into this
trial with their consent. All the participants will be recruited by WellSleep, Wellington.

Participants will use the trial mask in home for a period of 7 ± 3 days. Baseline data will
be collected from the participant during the first visit, the prior 7 days of CPAP usage data
will be downloaded and stored for our analysis. The participant will use the trial device on
their usual CPAP/APAP setting and device for the duration of the trial.

This study will be conducted in accordance with ICH/GCP guidelines. No deviation from the
protocol will be implemented without prior review and approval of the sponsor except where it
may be necessary to eliminate an immediate hazard to a research participant. In such case,
the deviation will be reported to the sponsor as soon as possible.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03075722
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/NCT03075722