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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02948010




Registration number
NCT02948010
Ethics application status
Date submitted
26/10/2016
Date registered
28/10/2016

Titles & IDs
Public title
CPAP Device In-lab Assessment NZ
Scientific title
CPAP Device In-lab Assessment NZ
Secondary ID [1] 0 0
CIA187
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 - Auto CPAP + comfort feature A
Treatment: Devices - Auto CPAP with comfort feature B
Treatment: Devices - Auto CPAP with no comfort feature
Treatment: Devices - Auto CPAP with comfort feature A+B
Treatment: Devices - CPAP with comfort feature A
Treatment: Devices - CPAP with comfort feature B
Treatment: Devices - CPAP with no comfort feature
Treatment: Devices - CPAP with comfort feature A + B
Treatment: Devices - CPAP at Sub therapeutic level

Active comparator: Auto CPAP + comfort feature A - Auto CPAP with comfort feature A using Fisher \& Paykel Healthcare CPAP Device

Active comparator: Auto CPAP with comfort feature B - Auto CPAP with comfort feature B using Fisher \& Paykel Healthcare CPAP Device

Active comparator: Auto CPAP with no comfort feature - Auto CPAP with no comfort feature using Fisher \& Paykel Healthcare CPAP Device

Active comparator: Auto CPAP with comfort feature A+B - Auto CPAP with comfort feature A+B using Fisher \& Paykel Healthcare CPAP Device

Active comparator: CPAP with comfort feature A - CPAP with comfort feature A using Fisher \& Paykel Healthcare CPAP Device

Active comparator: CPAP with comfort feature B - CPAP with comfort feature B using Fisher \& Paykel Healthcare CPAP Device

Active comparator: CPAP with no comfort feature - CPAP with no comfort feature using Fisher \& Paykel Healthcare CPAP Device

Active comparator: CPAP with comfort feature A + B - CPAP with comfort feature A + B using Fisher \& Paykel Healthcare CPAP Device

Active comparator: CPAP at Sub therapeutic level - CPAP at Sub therapeutic level using Fisher \& Paykel Healthcare CPAP Device


Treatment: Devices: Auto CPAP + comfort feature A
Auto CPAP + comfort feature A using Fisher \& Paykel Healthcare CPAP Device

Treatment: Devices: Auto CPAP with comfort feature B
Auto CPAP with comfort feature B using Fisher \& Paykel Healthcare CPAP Device

Treatment: Devices: Auto CPAP with no comfort feature
Auto CPAP with no comfort feature using Fisher \& Paykel Healthcare CPAP Device

Treatment: Devices: Auto CPAP with comfort feature A+B
Auto CPAP with comfort feature A+B using Fisher \& Paykel Healthcare CPAP Device

Treatment: Devices: CPAP with comfort feature A
CPAP with comfort feature A using Fisher \& Paykel Healthcare CPAP Device

Treatment: Devices: CPAP with comfort feature B
CPAP with comfort feature B using Fisher \& Paykel Healthcare CPAP Device

Treatment: Devices: CPAP with no comfort feature
CPAP with no comfort feature using Fisher \& Paykel Healthcare CPAP Device

Treatment: Devices: CPAP with comfort feature A + B
CPAP with comfort feature A + B using Fisher \& Paykel Healthcare CPAP Device

Treatment: Devices: CPAP at Sub therapeutic level
CPAP at Sub therapeutic level using 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) (i.e. number of events/hour).
Timepoint [1] 0 0
4 months
Primary outcome [2] 0 0
Log of safety-related events, measured as number of safety-related faults
Timepoint [2] 0 0
4 months
Primary outcome [3] 0 0
Machine reported faults, measured as number of machine faults
Timepoint [3] 0 0
4 months
Secondary outcome [1] 0 0
Participant perception of the device, as determined by the questionnaire responses
Timepoint [1] 0 0
4 months

Eligibility
Key inclusion criteria
* 18 years or older
* Diagnosed with OSA by a practicing physician and prescribed PAP therapy (fixed or auto CPAP)
* 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
* Be contraindicated for PAP (fixed or auto CPAP) therapy.
* Have another significant sleep disorder(s) (e.g. periodic leg movements or insomnia).
* Have obesity hypoventilation syndrome or congestive heart failure.
* Require supplemental oxygen with your PAP (fixed or auto CPAP) device.
* Have any implanted electronic medical devices (e.g. cardiac pacemakers).
* Be pregnant or think they might be pregnant.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
NA
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
1/11/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2017
Sample size
Target
Accrual to date
Final
104
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02948010