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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/NCT02948010




Registration number
NCT02948010
Ethics application status
Date submitted
26/10/2016
Date registered
28/10/2016
Date last updated
27/06/2017

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
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
1/11/2016
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
The purpose of this trial is to assess device performance against participants in an
overnight study to ensure the product meets user and clinical requirements
Trial website
https://clinicaltrials.gov/ct2/show/NCT02948010
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