Study to Determine the Effectiveness of Pillar Palatal Implants to Treat Obstructive Sleep Apnea
NCT ID: NCT00307957
Last Updated: 2007-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2005-10-31
2006-10-31
Brief Summary
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Detailed Description
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In both cases, patients come into the office for placement of the implants. This is an outpatient procedure. Patients are followed at one week, one month and 3 months. At each follow-up visit, patients will undergo a physical exam and complete questionnaires related to sleep and quality of life. Patients will also undergo reaction time testing on hand-held device similar to a pocket video game. At the three month visit, patients will return to the sleep lab for another sleep study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Pillar Palatal Implants
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Medtronic Xomed, Inc.
INDUSTRY
University of Cincinnati
OTHER
Principal Investigators
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David L Steward, MD
Role: PRINCIPAL_INVESTIGATOR
University Ear, Nose and Throat Specialists
Locations
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University of Indiana Medical Center
Indianapolis, Indiana, United States
University Ear, Nose and Throat Specialists
Cincinnati, Ohio, United States
Department of OTO-HNS Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Related Links
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Manufacturer's website for more information on Pillar Implants
Other Identifiers
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05-08-14-1
Identifier Type: -
Identifier Source: org_study_id