Back to resultsEvaluation of Acclimate Feature for Positive Airway Pressure (PAP) Therapy
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
S9 Elite with Acclimate
S9 Elite
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring OSA, Sleep Apnea, PAP, positive airway pressure
Eligibility 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.
Sites / Locations
- Sleep Insights
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fixed Mode + Acclimate
Fixed Mode only
Arm Description
S9 Elite flow generator with Acclimate feature activated.
S9 Elite Flow Generator with Fixed Mode only
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01421654
Brief Title
Evaluation of Acclimate Feature for Positive Airway Pressure (PAP) Therapy
Official Title
Evaluation of Positive Airway Pressure (PAP) Feature to Improve Patient Adherence to Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ResMed
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
OSA, Sleep Apnea, PAP, positive airway pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fixed Mode + Acclimate
Arm Type
Experimental
Arm Description
S9 Elite flow generator with Acclimate feature activated.
Arm Title
Fixed Mode only
Arm Type
Active Comparator
Arm Description
S9 Elite Flow Generator with Fixed Mode only
Intervention Type
Device
Intervention Name(s)
S9 Elite with Acclimate
Intervention Description
S9 Elite Flow Generator with Acclimate feature activated
Intervention Type
Device
Intervention Name(s)
S9 Elite
Intervention Description
S9 Elite Flow Generator
Primary Outcome Measure Information:
Title
Hours Used
Description
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.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ken Plotkin, MD
Organizational Affiliation
Sleep Insights
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sleep Insights
City
Rochester
State/Province
New York
ZIP/Postal Code
14625
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Acclimate Feature for Positive Airway Pressure (PAP) Therapy
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