Status:
COMPLETED
Modified AutoSet Device vs Existing AutoSet Device, the Assessment of Efficacy and Subjective Comfort of the Treatment.
Lead Sponsor:
ResMed
Conditions:
Sleep Apnea
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of this study is to determine if the performance of the modified AutoSet device is equivalent or better than the existing AutoSet device (VPAP Auto) in the efficacy of the treatment and th...
Detailed Description
Obstructive sleep apnea (OSA) is characterised by a partial or complete collapse of the upper airway during sleep. The treatment of choice for OSA is Continuous Positive Airway Pressure (CPAP). CPAP a...
Eligibility Criteria
Inclusion
- Patients aged 18-80 years
- Patients who are on CPAP therapy in AUTOSET mode for no less than 6 months
- Patients who are using ResMed masks
Exclusion
- Patients who are unable to provide written informed consent
- Patients who are unable to comprehend written and spoken English
- Patients who are using Bilevel PAP
- Patients who are pregnant
- Patients who are suffering any of the following:
- Acute respiratory infection
- Acute sinusitis, otitis media or perforated eardrum
- Pneumothorax or pneumomediastinum
- Recent history of severe epistaxis requiring medical attention
Key Trial Info
Start Date :
May 11 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00906958
Start Date
May 11 2009
End Date
June 15 2009
Last Update
March 22 2021
Active Locations (1)
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1
Centre for Healthy Sleep
Bella Vista, New South Wales, Australia, 2135