Status:
COMPLETED
Evaluation of Acclimate Feature for Positive Airway Pressure (PAP) Therapy
Lead Sponsor:
ResMed
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of the study is to evaluate if using the Acclimate feature at the beginning of Positive Airway Pressure (PAP) therapy results in patients using their PAP therapy at least as long as they w...
Detailed Description
Acclimate has been designed as a comfort feature for patients starting PAP therapy. The feature allows acclimatization to the targeted positive airway pressure setting. Using the Acclimate feature, th...
Eligibility Criteria
Inclusion
- Subjects ≥18 years of age.
- Recent diagnosis of moderate to severe OSA where fixed PAP is clinically indicated.
- Naïve to PAP therapy.
Exclusion
- Patients requiring supplemental oxygen.
- Patients with a history of pneumothorax, pneumomediastinum, cavities or cysts in the lung.
- Previous surgery to the brain, middle or inner ear, pituitary gland or sinuses.
- Middle ear infection or perforated ear drum.
- Ongoing sinus infection/sinusitis.
- Clinically significant epistaxis.
- Predominant central sleep apneas in the subject's PSG.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01421654
Start Date
September 1 2011
End Date
December 1 2011
Last Update
March 12 2013
Active Locations (1)
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1
Sleep Insights
Rochester, New York, United States, 14625