Status:
COMPLETED
Study to Determine the Effectiveness of Pillar Palatal Implants to Treat Obstructive Sleep Apnea
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
Medtronic Xomed, Inc.
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The Pillar palatal implant procedure is a minimally invasive and commercially available treatment for mild to moderate obstructive sleep apnea (OSA) in the United States and Europe. The implants are p...
Detailed Description
Patients will be enrolled into the study based on sleep study results, a physical exam and inclusion/exclusion criteria. Once enrolled, patients are randomized into either the Pillar palatal implant g...
Eligibility Criteria
Inclusion
- 18 years or older
- Body Mass Index equal to 32 or less
- Apnea-Hypopnea Index greater than/equal to 10 and less than/equal to 30
- Symptoms of daytime sleepiness
Exclusion
- Septal deviation or nasal obstruction
- Nasal polyps
- Severe seasonal allergies
- Soft palate length insufficient to accommodate implants
- Fujita Modified Mallampati Class 3
- Large tonsils
- Lingual tonsil hypertrophy
- Hypopharyngeal obstruction
- Previous pharyngeal surgery
- Previous upper respiratory tract cancer or radiation therapy
- Active respiratory tract infection
- Dysphagia or speech disorder
- Neurologic disorder
- Unstable psychiatric disorder
- Pregnant or breastfeeding
- History of falling asleep driving or MVA due to sleepiness
- Currently on CPAP therapy or other device for OSA
- Other sleep disorders
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2006
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00307957
Start Date
October 1 2005
End Date
October 1 2006
Last Update
December 12 2007
Active Locations (3)
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1
University of Indiana Medical Center
Indianapolis, Indiana, United States
2
University Ear, Nose and Throat Specialists
Cincinnati, Ohio, United States, 45267-0528
3
Department of OTO-HNS Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53022