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Completed

NCT Number: NCT01421654

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

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sleep Insights

Rochester, New York, 14625, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

S9 Elite with Acclimate

Device

S9 Elite Flow Generator with Acclimate feature activated

S9 Elite

Device

S9 Elite Flow Generator

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 23, 2011
Registry last updated
Mar 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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