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

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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: S9 Elite with Acclimate; Device: S9 Elite

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14625
      • Sleep Insights

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fixed Mode + Acclimate; S9 Elite flow generator with Acclimate feature activated.	Device: S9 Elite with Acclimate; S9 Elite Flow Generator with Acclimate feature activated
Active Comparator: Fixed Mode only; S9 Elite Flow Generator with Fixed Mode only	Device: S9 Elite; S9 Elite Flow Generator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: ResMed
• Investigators: Principal Investigator: Ken Plotkin, MD, Sleep Insights

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: August 19, 2011
• First Submitted That Met QC Criteria: August 22, 2011
• First Posted (Estimate): August 23, 2011

Study Record Updates

• Last Update Posted (Estimate): March 12, 2013
• Last Update Submitted That Met QC Criteria: March 10, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: OSA; Sleep Apnea; positive airway pressure; PAP
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: MA-03-11-01