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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02804919




Registration number
NCT02804919
Ethics application status
Date submitted
15/06/2016
Date registered
17/06/2016
Date last updated
3/08/2018

Titles & IDs
Public title
CPAP In-home Assessment NZ
Scientific title
CPAP In-home Assessment NZ
Secondary ID [1] 0 0
CIA174
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 hour. - Obtained from the device - Phase 1 and Phase 2 of the trial
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 - Phase 1 and Phase 2 of the trial
Timepoint [2] 0 0
6 months
Primary outcome [3] 0 0
Machine reported faults, measured as number of machine faults - Obtained from the device - Phase 1 and Phase 2 of the trial
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 - Phase 1 and Phase 2 of the trial
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 - Phase 1 only
Timepoint [1] 0 0
6 months

Eligibility
Key inclusion criteria
- Aged 18 and over

- Diagnosed with Obstructive Sleep Apnea (OSA) and prescribed Positive Airway Pressure
(either Continuous positive airway pressure (CPAP) or AutoCPAP)

- Be fluent in spoken and written English
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Contraindicated for Positive Airway Pressure (CPAP or AutoCPAP) 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 Positive Airway Pressure (CPAP or
AutoCPAP) device.

- Persons with implanted electronic medical devices (e.g cardiac pacemakers)

- Persons who are pregnant or think they may be pregnant.

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)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

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

Ethics approval
Ethics application status

Summary
Brief summary
Phase 1: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.

Phase 2: To evaluate the CPAP device with communication functionality with data upload.
Trial website
https://clinicaltrials.gov/show/NCT02804919
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Irene Cheung, MSc/RPSGT
Address 0 0
Fisher & Paykel Healthcare
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