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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00739011




Registration number
NCT00739011
Ethics application status
Date submitted
19/08/2008
Date registered
21/08/2008
Date last updated
9/12/2008

Titles & IDs
Public title
Validation of HC250 and HC240 Series.
Scientific title
Validation of Customer Requirements for the HC244/HC254
Secondary ID [1] 0 0
FPHC240/250Val
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea (OSA) 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 - SleepStyle 254/244 CPAP series CPAP humidifier

Experimental: 1 -


Treatment: Devices: SleepStyle 254/244 CPAP series CPAP humidifier
Therapeutic CPAP pressure will be determined for individual subjects during the titration portion of an overnight sleep study. This pressure will range from 4 to 20 cmH20

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Apnea Hypopnea Index (AHI)
Timepoint [1] 0 0
At the end of the sleep study

Eligibility
Key inclusion criteria
Inclusions criteria:

- AHI > 15 on the diagnostic night or portion of the split night study.

- =18yrs of age
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- Significant Central Apnea

- CHF

- Co-existing obesity related hypoventilation

- Inability to give informed consent

- Patient intolerance to CPAP

- Anatomical or physiological conditions making CPAP therapy inappropriate.

- Less than 3 hours in the titration period

- Under Land Transport New Zealand (LTNZ) investigation

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
This study is designed to determine the effectiveness of two different CPAP devices. One a
standard CPAP which has the ability to store comprehensive compliance and efficacy data and
the second a auto adjusting CPAP which uses the energy spectrum analysis of flow signals to
automatically adjust CPAP pressure and improve sleep variables.
Trial website
https://clinicaltrials.gov/show/NCT00739011
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jessica Hayward, MSc
Address 0 0
Fisher and 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