ACTRN12613001282774
Completed
未知
An evaluation involving an in-lab assessment of a continuous positive airway pressure (CPAP) device for the treatment of Obstructive Sleep Apnea (OSA) along with changes in pressure, humidity and therapy modes to determine whether the device provides the same therapy and comfort as its predecessor and similar released products on the market.
Hanie Yee0 sites300 target enrollmentNovember 20, 2013
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Obstructive Sleep Apnea
- Sponsor
- Hanie Yee
- Enrollment
- 300
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosed with OSA by a practicing sleep physician
- •AHI \> 5 from diagnostic night
Exclusion Criteria
- •Patients with a known history ofCerebrospinal 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 for patients who have an increased risk of pneumothorax, such as those with bullous lung disease
- •Patient with bypassed upper airway
- •Other significant sleep disorder(s) (e.g. periodic leg movements, insomnia, central sleep apnea)
- •Patients with obesity hypoventilation syndrome or congestive heart failure
- •Patients that require supplemental oxygen with their CPAP device
- •Patients with implanted electronic medical devices (e.g. cardiac pacemakers)
Outcomes
Primary Outcomes
Not specified
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