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

Obstructive Sleep Apnea Clinical Trial

Official title:

Evaluation of Positive Airway Pressure (PAP) Feature to Improve Patient Adherence to Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01421654
• Other study ID #: MA-03-11-01
• Status: Completed
• Phase: N/A
• First received: August 19, 2011
• Last updated: March 10, 2013
• Start date: September 2011
• Est. completion date: December 2011

Study information

• Verified date: January 2013
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Device:
• S9 Elite with Acclimate
S9 Elite Flow Generator with Acclimate feature activated
• S9 Elite
S9 Elite Flow Generator

Locations

Country	Name	City	State
United States	Sleep Insights	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hours Used	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.	30 days	No