Status:
COMPLETED
SensAwake™ Sleep Quality Trial
Lead Sponsor:
Fisher and Paykel Healthcare
Conditions:
Sleep Apnea, Obstructive
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The SensAwake™ modification to the Fisher and Paykel automatically titrating positive airway pressure (APAP) device aims to sense whether the patient is awake via respiratory patterns that differentia...
Eligibility Criteria
Inclusion
- Aged 18-65 years with moderate-to-severe OSA (Apnea Hypopnea index equal to or greater than 15 per hour).
- 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
- Participants prescribed and fitted with any PAP device in the past 2 years.
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2009
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00811213
Start Date
October 1 2008
End Date
August 1 2009
Last Update
July 12 2011
Active Locations (1)
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1
Woolcock Institute of Medical Research
Sydney, New South Wales, Australia, 2037