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/NCT02809794




Registration number
NCT02809794
Ethics application status
Date submitted
19/06/2016
Date registered
22/06/2016
Date last updated
27/06/2017

Titles & IDs
Public title
CPAP In-home Assessment Australia
Scientific title
CPAP In-home Assessment Australia
Secondary ID [1] 0 0
CIA175
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 - Fisher & Paykel Healthcare CPAP Device

Experimental: Investigational CPAP device - Fisher \& Paykel Healthcare CPAP Device


Treatment: Devices: Fisher & Paykel Healthcare CPAP Device
Fisher \& Paykel Healthcare CPAP Device
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Apnea Hypopnea Index (AHI), measured as number of events/hour
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
Log of safety-related events, measured as number of safety-related faults
Timepoint [2] 0 0
6 months
Primary outcome [3] 0 0
Machine reported faults, measured as number of machine faults
Timepoint [3] 0 0
6 months
Primary outcome [4] 0 0
Participant reported faults, measured as number of participant complaints
Timepoint [4] 0 0
6 months
Secondary outcome [1] 0 0
Perception of the device, measured through questionnaire
Timepoint [1] 0 0
6 months

Eligibility
Key inclusion criteria
* Aged 18 and over.
* Diagnosed with OSA by a practicing physician and prescribed Positive Airway Pressure (PAP) therapy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Persons contraindicated for Continuous Positive Airway Pressure (CPAP) therapy.
* Persons with other significant sleep disorder(s) (e.g. periodic leg movements, insomnia, central sleep apnea).
* Persons with obesity hypoventilation syndrome or congestive heart failure.
* Persons that require supplemental oxygen with their CPAP device.
* Persons with implanted electronic medical devices (e.g. cardiac pacemakers).
* Persons who are pregnant or think they might be pregnant.
* Persons whose primary language is other than English.
* Persons in existing dependent or unequal relationships with any member of the research team, the researcher(s) and/or the person undertaking the recruitment/consent process.
* Persons highly dependent on medical care.
* People with cognitive impairment, an intellectual disability or a mental illness

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
1/07/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2017
Sample size
Target
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Sleep Matters - Bulleen
Recruitment hospital [2] 0 0
Sleep & Snore Solutions - Bunbury
Recruitment hospital [3] 0 0
St John of God Midland Public Hospital - Midland
Recruitment postcode(s) [1] 0 0
3105 - Bulleen
Recruitment postcode(s) [2] 0 0
6230 - Bunbury
Recruitment postcode(s) [3] 0 0
6056 - Midland

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

Ethics approval
Ethics application status

Summary
Brief summary
The study is to evaluate the product reliability, therapy effectiveness and user feedback of a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months.
Trial website
https://clinicaltrials.gov/study/NCT02809794
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/NCT02809794