Status:
COMPLETED
Continuous Positive Airway Pressure (PAP) Titration and Treatment Versus Auto-adjusting PAP Treatment for Sleep Apnea
Lead Sponsor:
North Florida Foundation for Research and Education
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
21-89 years
Phase:
NA
Brief Summary
The purpose of this randomized prospective study is to compare the efficacy of two approaches to initiate Positive Airway Pressure (PAP) treatment in patients diagnosed as having obstructive sleep apn...
Detailed Description
RESEARCH PLAN: All patients being evaluated for possible OSA are required to attend a Sleep Education and Evaluation Class before having a sleep study. At this class they receive information on sleep ...
Eligibility Criteria
Inclusion
- OSA, Apnea-hypopnea index \> 5/hour
Exclusion
- Prior CPAP
- Uncontrolled Depression
- Moderate to Severe chronic obstructive pulmonary disease (COPD)
- Hypoventilation
- Average estimated nightly total sleep time \< 4 hours
- Shift work
- Unstable depression
- Upper airway surgery
- Uncontrolled Restless legs syndrome (RLS), narcolepsy
- Use of supplemental oxygen
- Severe congestive heart failure
- Use of nightly potent narcotics
- Severe obesity (BMI \> 40)
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT00988351
Start Date
February 1 2010
End Date
December 1 2012
Last Update
November 3 2014
Active Locations (1)
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1
Malcom Randall VA Medical Center
Gainesville, Florida, United States, 32608