Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
45 participants
INTERVENTIONAL
2008-10-31
2009-08-31
Brief Summary
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A total number of 45 participants will be recruited from an OSA population, aged 18-65. Participants will consist of male and female patients diagnosed with moderate-severe OSA (Apnea Hypopnea Index (AHI) greater than or equal to 15 per hour. Eligible participants, according to the protocol approved by the HREC, providing written informed consent will be enrolled into the study. Patients will be enrolled sequentially according to the randomisation list. Patients will be randomised to APAP or APAP with the addition of the SensAwake™ modification. The investigator and study staff will be blinded to the treatment of any participant.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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1
Auto adjusting Continuous Postive Aiway Pressure (CPAP) Device with SensAwake technology enabled
SleepStyle 200 Auto Series with SensAwake
Auto adjusting Continuous Postive Aiway Pressure (CPAP) Device with SensAwake technology enabled
2
Auto adjusting Continuous Postive Aiway Pressure (CPAP) Device with SensAwake technology disabled
SleepStyle 200 Auto Series with out SensAwake
Auto adjusting Continuous Postive Aiway Pressure (CPAP) Device with SensAwake technology disabled
Interventions
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SleepStyle 200 Auto Series with SensAwake
Auto adjusting Continuous Postive Aiway Pressure (CPAP) Device with SensAwake technology enabled
SleepStyle 200 Auto Series with out SensAwake
Auto adjusting Continuous Postive Aiway Pressure (CPAP) Device with SensAwake technology disabled
Eligibility Criteria
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Inclusion Criteria
* Epworth Sleepiness Scale (ESS) scores 0-15 inclusive (normal to moderately severe daytime sleepiness).
* Fluency in both written and spoken English.
* Do not have unstable psychiatric disease.
* No other significant sleep disorder.
Exclusion Criteria
* Unstable cardiovascular disease (untreated or resistant hypertension acceptable).
* Inability to tolerate CPAP due to nasal obstruction or claustrophobia as determined by the study investigator.
* Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as psychiatric disease, history of non compliance to medical regimens, or unwillingness to comply with study requirements.
* Participation in another clinical trial in the previous month.
18 Years
65 Years
ALL
No
Sponsors
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Fisher and Paykel Healthcare
INDUSTRY
Responsible Party
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Fisher & Paykel Healthcare
Principal Investigators
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Brendon Yee, MBChB
Role: PRINCIPAL_INVESTIGATOR
Woolcock Institute of Medical Research
Locations
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Woolcock Institute of Medical Research
Sydney, New South Wales, Australia
Countries
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References
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Dungan GC 2nd, Marshall NS, Hoyos CM, Yee BJ, Grunstein RR. A randomized crossover trial of the effect of a novel method of pressure control (SensAwake) in automatic continuous positive airway pressure therapy to treat sleep disordered breathing. J Clin Sleep Med. 2011 Jun 15;7(3):261-7. doi: 10.5664/JCSM.1066.
Related Links
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Study Site
Sponsor site
Other Identifiers
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FP-08E-108
Identifier Type: -
Identifier Source: org_study_id
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