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/ct2/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.
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 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
Sex
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
N/A
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
16/06/2017
Sample size
Target
Accrual to date
Final
30
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02804919