N/A
Completed N=20
Evaluation of Acclimate Feature for Positive Airway Pressure (PAP) Therapy
Source: ClinicalTrials.gov NCT01421654 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcomePrimary: Hours Used — 146.9; 141.9 Total Hours Used
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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hours Used |
146.9; 141.9 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects ≥18 years of age.
- Recent diagnosis of moderate to severe OSA where fixed PAP is clinically indicated.
- Naïve to PAP therapy.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01421654). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.