Status:
COMPLETED
Improved Automatic CPAP Algorithm to Treat Obstructive Sleep Apnea (OSA)
Lead Sponsor:
ResMed
Conditions:
Obstructive Sleep Apnea (OSA)
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The purpose of this study is to compare a modified AutoSet algorithm running on research hardware versus the traditional AutoSet algorithm running on an S7 AutoSet Spirit. The study will determine if ...
Detailed Description
Subjects in the trial will spend 2 nights in a sleep laboratory being monitored with a full montage polysomnograph (PSG) with each of the algorithms providing positive airway pressure therapy. The PSG...
Eligibility Criteria
Inclusion
- PSG-confirmed diagnosis of OSA, showing an apnoea-hypopnoea index (AHI) of at least 15 events/hr and an obstructive apnoea index (OAI) of at least 5 events/hr.
- On CPAP therapy (fixed pressure or autoCPAP) for at least 1 month.
- Using a ResMed mask (this requirement applies only to phase 2 of the trial) without significant discomfort for at least 2 weeks.
- Age between 18 and 70 years.
- Written informed consent.
Exclusion
- Unstable medical condition, including unstable angina, myocardial infarction within previous 6 months, cardiac failure NYHA grades III and IV, epilepsy, psychiatric disturbance.
- Respiratory insufficiency, defined as arterial CO2 greater than 50 mm Hg during the daytime or arterial oxygen saturation less than 90% when asleep and breathing room air on effective CPAP therapy.
- Recent severe epistaxis.
- History of spontaneous pneumothorax.
- History of regurgitation of gastric contents during sleep.
- Unable to give written informed consent.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00850434
Start Date
November 1 2005
End Date
November 1 2008
Last Update
February 4 2021
Active Locations (1)
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1
Sleep & Chest Disorders Centre
Sydney, New South Wales, Australia, 2000