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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: S9 Elite; Device: S9 Elite with Acclimate

• Registration Number: NCT01421654
• Lead Sponsor: ResMed

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 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.

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, the pressure increases incrementally over a period of time. The feature can be only be used for a set period of time, afterwards which the device initiates the therapeutic session at the prescribed pressure.

Study Timeline

• Study First Submitted: 2011-08-19
• Study First Submitted QC: 2011-08-22
• Study First Posted: 2011-08-23
• Study Start: 2011-09
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2013-01
• Results First Submitted: 2013-01-31
• Results First Submitted QC: 2013-01-31
• Results First Posted: 2013-03-07
• Last Update Submitted: 2013-03-10
• Last Update Posted: 2013-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fixed Mode only	S9 Elite	S9 Elite Flow Generator with Fixed Mode only
Fixed Mode + Acclimate	S9 Elite with Acclimate	S9 Elite flow generator with Acclimate feature activated.

Primary Outcome Measures

Name	Time	Method
Hours Used	30 days	The number of hours that each group used the device will be compared between subjects using fixed pressure with the Acclimate mode and subjects using fixed pressure without the Acclimate mode.

Trial Locations

Locations (1)

Sleep Insights; 🇺🇸 Rochester, New York, United States