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/NCT03725839




Registration number
NCT03725839
Ethics application status
Date submitted
28/10/2018
Date registered
31/10/2018
Date last updated
28/02/2020

Titles & IDs
Public title
The Evaluation of an Interface for the Treatment of Obstructive Sleep Apnea (OSA)
Scientific title
The Evaluation of an Interface for the Treatment of Obstructive Sleep Apnea (OSA)
Secondary ID [1] 0 0
CIA-249
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 - F&P Interface

Experimental: Arm - F\&P Interface will be used by OSA participants in-home for 2 weeks.


Treatment: Devices: F&P Interface
F\&P Interface to be used for OSA therapy
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Trial Mask usability
Timepoint [1] 0 0
14 ± 4 days in home
Primary outcome [2] 0 0
Trial mask Performance
Timepoint [2] 0 0
14 ± 4 days in home
Secondary outcome [1] 0 0
Trial mask Reliability
Timepoint [1] 0 0
5 months and 2 weeks in home
Secondary outcome [2] 0 0
Trial mask performance measured in L/min
Timepoint [2] 0 0
14 ± 4 days in home

Eligibility
Key inclusion criteria
* Adult (18+ years of age)
* Able to give written consent
* AHI = 5 on diagnostic night
* Either prescribed APAP, CPAP or Bi-level PAP for OSA
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Inability to give written consent
* Anatomical or physiological conditions making PAP therapy inappropriate
* Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
* Current diagnosis of respiratory disease or CO2 retention
* Pregnant or may think they are pregnant.

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
5/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/11/2019
Sample size
Target
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Hawkes Bay
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland
Country [3] 0 0
New Zealand
State/province [3] 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 as well as the patients overall acceptance of the interface.
Trial website
https://clinicaltrials.gov/study/NCT03725839
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bhavi Ogra
Address 0 0
Clinical Manager
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/NCT03725839