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/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
Sex
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
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
1/08/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2008
Sample size
Target
40
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00739011