Status:
COMPLETED
Evaluation of Treatment Efficacy and Comfort of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea.
Lead Sponsor:
Fisher and Paykel Healthcare
Conditions:
Obstructive Sleep Apnea (OSA)
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
This study will test the hypothesis that the modified positive airway pressure (PAP) device for OSA will be no worse than a market released product in terms of its treatment efficacy, comfort and pati...
Detailed Description
The study will be held in two parts. The main portion of the study which compares the modified PAP device and the market released product including the laboratory testing and home testing of the devic...
Eligibility Criteria
Inclusion
- Aged 18+
- Diagnosed with OSA by a practicing sleep physician
Exclusion
- Patients with a known history of Cerebrospinal fluid leak, abnormalities of the cribriform plate, head trauma and/or pneumocephalus
- Patients with pathologically low blood pressure, pneumothorax, a previous history of pneumothorax, or dehydration.
- Patient with bypassed upper airway
- Other significant sleep disorder(s) (e.g. periodic leg movements, insomnia, central sleep apnea)
- Previous use of a bi-level device with-in the last 2 years (from enrolment date).
- Patients with respiratory failure, bullous lung disease or COPD (Chronic Obstructive Pulmonary Disease).
- Patients with obesity hypoventilation syndrome or congestive heart failure
- Patients that require supplemental oxygen with their CPAP (Continuous Positive Airway Pressure) device
- Patients with implanted or life-supporting electronic medical devices (e.g. cardiac pacemakers)
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT02214238
Start Date
August 1 2014
End Date
November 1 2015
Last Update
April 24 2017
Active Locations (1)
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1
Fisher & Paykel Healthcare
Auckland, New Zealand, 2013