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

Completed · Phase 4

Conditions studied: Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT00307957

Run by

University of Cincinnati

People needed

100

Starts

2005-10-01

Expected to finish

2006-10-01

Last updated by the study team

2007-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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