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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - Obtained from the device
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
Log of safety-related events, measured as number of safety-related faults - Obtained from the device
Timepoint [2] 0 0
6 months
Primary outcome [3] 0 0
Machine reported faults, measured as number of machine faults - Obtained from the device
Timepoint [3] 0 0
6 months
Primary outcome [4] 0 0
Participant reported faults, measured as number of participant complaints - Obtained from the follow up visits
Timepoint [4] 0 0
6 months
Secondary outcome [1] 0 0
Perception of the device, measured through questionnaire - Impression of the device during the follow up visits
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
Gender
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
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)
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/show/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
Other publications