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Study to Determine the Effectiveness of Pillar Palatal Implants to Treat Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:
Pillar Palatal Implant System Multi-Institutional, Randomized Placebo-Controlled Study for Obstructive Sleep Apnea

Clinical Trial 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 placed into the soft area in the roof of the mouth providing support to the soft palate. This research is being done to compare daytime sleepiness and sleep related quality of life after palatal implants.

Clinical Trial 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 group or a placebo/sham group.

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00307957
Study type Interventional
Source University of Cincinnati
Contact
Status Completed
Phase Phase 4
Start date October 2005
Completion date October 2006
View Details
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