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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/NCT00697424




Registration number
NCT00697424
Ethics application status
Date submitted
11/06/2008
Date registered
13/06/2008
Date last updated
9/12/2008

Titles & IDs
Public title
Comparison of Breathing Events Detected by the SleepStyle 200 Auto Continuous Positive Airway Pressure (CPAP) Device to Attended Polysomnography
Scientific title
Investigation of Methods to Detect Respiratory Irregularities in Obstructive Sleep Apnea (OSA)
Secondary ID [1] 0 0
AKY/03/07/166
Secondary ID [2] 0 0
FPHHC254a
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Apnea, Obstructive 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 200 Auto Series CPAP Humidifier

Experimental: 1 - All subjects will be placed on continuous positive airway pressure (CPAP) therapy during a full night sleep study or polysomnography (PSG). The subjects will spend 2 hours on sub-therapeutic CPAP 4 cmH2O of pressure and the remainder on there therapeutic pressure. Values reported on the device will be compared to scored values from manual scoring of the sleep study.


Treatment: Devices: SleepStyle 200 Auto Series CPAP Humidifier
The device will record on internal software perceived sleep disordered breathing events. Events will also be scored manually on the polysomnography (PSG. Results will then be compared.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Apnea Hypopnea Index
Timepoint [1] 0 0
At the end of the sleep study.
Secondary outcome [1] 0 0
Respiratory Disturbance Index (RDI)
Timepoint [1] 0 0
At the end of the sleep study (PSG)

Eligibility
Key inclusion criteria
- Apnea Hypopnea Index (AHI) >15 from diagnostic night

- =18 years of age
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Contraindicated for CPAP use

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
1/05/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2008
Sample size
Target
20
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
Obstructive Sleep Apnoea (OSA) is a common sleep-breathing disorder affecting around 2-4% of
the population and is characterised by loud snoring, periodic collapse of the upper airway
particular to sleep, sleep fragmentation, and sometimes daytime sleepiness. Health
consequences include impaired cognitive functioning, quality of life, mood, and increased
cardiovascular disease risk. Epidemiological studies have demonstrated that increased
morbidity and mortality in a dose response manner with increasing severity of sleep
disordered breathing.

The standard treatment for OSA is nasal Continuous Positive Airway Pressure (CPAP), which
consists of pressurized air applied to the nose via a mask. Generally a single, optimal
pressure is prescribed for a patient based on a full night or partial night study during
which the pressure is adjusted by a technician until all sleep disordered breathing (SDB)
events are abolished. Despite therapy efficacy, compliance to CPAP therapy is sub-optimal.

Due to low compliance it has become common for healthcare providers to follow up subject
therapy efficacy through reporting software inherent in many current CPAP devices. Healthcare
providers can use this reported data to make appropriate treatment decisions. For this reason
the data needs to be accurate. The SleepStyle™ 200 Auto Series CPAP humidifier is an auto
adjusting CPAP which stores comprehensive compliance data. The aim of this study is to
compare the reliability of the SleepStyle™ 200 Auto Series CPAP data to laboratory-based PSG
in detecting sleep disordered breathing.

Hypothesis: The SleepStyle™ 200 Auto Series reporting features accurately detects indices of
sleep disordered breathing.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00697424
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jessica R Hayward, Msc
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