Evaluation of Acclimate Feature for Positive Airway Pressure (PAP) Therapy

Completed · Not applicable

Conditions studied: Obstructive Sleep Apnea

In brief

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 would standard therapy. Additionally, the Acclimate feature will be evaluated with regard to patient comfort, ease of acceptance of PAP therapy, leak events, and respiratory events.

Key facts

Study ID

NCT01421654

Run by

ResMed

People needed

20

Starts

2011-09-01

Expected to finish

2011-12-01

Last updated by the study team

2013-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects ≥18 years of age.
• Recent diagnosis of moderate to severe OSA where fixed PAP is clinically indicated.
• Naïve to PAP therapy.

You may not qualify if…

• 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.

Where it is running

• Sleep Insights — Rochester, New York, United States

Full record on ClinicalTrials.gov

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