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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01421654
Recruitment Status : Completed
First Posted : August 23, 2011
Results First Posted : March 7, 2013
Last Update Posted : March 12, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: S9 Elite with Acclimate Device: S9 Elite Not Applicable

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  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of Positive Airway Pressure (PAP) Feature to Improve Patient Adherence to Therapy
Study Start Date : September 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Hours Used [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01421654

United States, New York
Sleep Insights
Rochester, New York, United States, 14625
Sponsors and Collaborators
Principal Investigator: Ken Plotkin, MD Sleep Insights

Responsible Party: ResMed Identifier: NCT01421654     History of Changes
Other Study ID Numbers: MA-03-11-01
First Posted: August 23, 2011    Key Record Dates
Results First Posted: March 7, 2013
Last Update Posted: March 12, 2013
Last Verified: January 2013

Keywords provided by ResMed:
Sleep Apnea
positive airway pressure

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases