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/study/NCT02541214




Registration number
NCT02541214
Ethics application status
Date submitted
1/09/2015
Date registered
4/09/2015
Date last updated
2/08/2019

Titles & IDs
Public title
Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea in New Zealand
Scientific title
Secondary ID [1] 0 0
CIA-171
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
Experimental: Trial Nasal Mask - The participant will use the Saturn nasal mask for 2 weeks in home
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Subjective measurements of comfort on the trial Nasal Mask gathered through a custom questionnaire
Timepoint [1] 0 0
2 weeks in home
Secondary outcome [1] 0 0
Seal performance of the trial Nasal mask as measured by the subjective perception of leak through a custom questionnaire, in addition to objective leak data and treatment efficacy through the Positive Airway Pressure therapy device.
Timepoint [1] 0 0
2 weeks in home
Secondary outcome [2] 0 0
Objective leak data through the Positive Airway Pressure therapy device
Timepoint [2] 0 0
2 weeks in home
Secondary outcome [3] 0 0
Treatment efficacy through the Positive Airway Pressure therapy device
Timepoint [3] 0 0
2 weeks in home
Secondary outcome [4] 0 0
Preference of the Trial Nasal mask compared to the participant's usual mask through a custom questionnaire.
Timepoint [4] 0 0
2 weeks in home

Eligibility
Key inclusion criteria
* Aged 18+
* Diagnosed with Ostructive Sleep Apnea by a practicing physician or clinicans
* Existing nasal or nasal pillows user
* Prescribed Positive Airway Pressure therapy (Bi-Level or Continuous Positive Airway Pressure (CPAP) or Automatic Positive Airway Pressure (APAP))
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Inability to give informed consent
* Pregnant or think they may be pregnant
* Anatomical or physiological conditions making Positive Airway Pressure therapy inappropriate (e.g unconsolidated facial fracture)
* Patients who are in a coma or decreased level of consciousness
* Current diagnosis of CO2 retention
* Commercial Drivers who are investigated by New Zealand Transport Agency (NZTA)

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
1/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2015
Sample size
Target
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Hamilton
Country [2] 0 0
New Zealand
State/province [2] 0 0
Hastings

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Fisher and Paykel Healthcare
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Currently, Fisher and Paykel Healthcare (FPH) is developing a new nasal mask.

This investigation is designed to evaluate the performance of the trial nasal mask, focused specifically on how the different seal sizes will perform on Obstructive Sleep Apnea participants who are currently on Positive Airway Pressure therapy.

Participant's prescribed treatment pressure with their usual mask will be collected for 7 days ± 3 days prior to mask fitting with the trial nasal mask. They will then be issued with the trial nasal mask to use in-home for 14 days ± 4 days.
Trial website
https://clinicaltrials.gov/study/NCT02541214
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/study/NCT02541214