Evaluation of Acclimate Feature for Positive Airway Pressure (PAP) Therapy
Evaluation of Positive Airway Pressure (PAP) Feature to Improve Patient Adherence to Therapy
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2011
CompletedFirst Posted
Study publicly available on registry
August 23, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
March 7, 2013
CompletedMarch 12, 2013
January 1, 2013
3 months
August 19, 2011
January 31, 2013
March 10, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
30 days
Study Arms (2)
Fixed Mode + Acclimate
EXPERIMENTALS9 Elite flow generator with Acclimate feature activated.
Fixed Mode only
ACTIVE COMPARATORS9 Elite Flow Generator with Fixed Mode only
Interventions
S9 Elite Flow Generator with Acclimate feature activated
Eligibility Criteria
You may qualify if:
- Subjects ≥18 years of age.
- Recent diagnosis of moderate to severe OSA where fixed PAP is clinically indicated.
- Naïve to PAP therapy.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ResMedlead
Study Sites (1)
Sleep Insights
Rochester, New York, 14625, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Amy Blase/Clinical Research Manager
- Organization
- ResMed
Study Officials
- PRINCIPAL INVESTIGATOR
Ken Plotkin, MD
Sleep Insights
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2011
First Posted
August 23, 2011
Study Start
September 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
March 12, 2013
Results First Posted
March 7, 2013
Record last verified: 2013-01