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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ResMed
ClinicalTrials.gov Identifier:
NCT01421654
First received: August 19, 2011
Last updated: March 10, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Obstructive Sleep Apnea
Device: S9 Elite with Acclimate
Device: S9 Elite

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Evaluation of Positive Airway Pressure (PAP) Feature to Improve Patient Adherence to Therapy

Resource links provided by NLM:


Further study details as provided by ResMed:

Primary Outcome Measures:
  • Hours Used [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: September 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01421654

Locations
United States, New York
Sleep Insights
Rochester, New York, United States, 14625
Sponsors and Collaborators
ResMed
Investigators
Principal Investigator: Ken Plotkin, MD Sleep Insights
  More Information

No publications provided

Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT01421654     History of Changes
Other Study ID Numbers: MA-03-11-01
Study First Received: August 19, 2011
Results First Received: January 31, 2013
Last Updated: March 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by ResMed:
OSA
Sleep Apnea
PAP
positive airway pressure

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014