Evaluation of Acclimate Feature for Positive Airway Pressure (PAP) Therapy
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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 |
- 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 |
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 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 May 21, 2013