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

This study is currently recruiting patients

Verified by University of Cincinnati March 2006

Sponsors and Collaborators: University of Cincinnati
Restore Medical
Information provided by: University of Cincinnati
ClinicalTrials.gov Identifier: NCT00307957


Purpose

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.

Condition Intervention Phase
Obstructive Sleep Apnea
Device: Pillar Palatal Implants Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by University of Cincinnati:
Primary Outcomes: Daytime Sleepiness (ESS); Apnea/Hypopnea Index (AHI)
Secondary Outcomes: Sleep Related Quality of Life (FOSQ); Reaction Time Testing (PVT); Other polysomnographic parameters (AI, HI, RERArl, Arl, LSat)
Expected Total Enrollment:  100

Study start: October 2005

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00307957

David L Steward, MD      513-558-4199    David.Steward@uc.edu
Chris Canter, BA      513-558-1719    Christine.Canter@uc.edu

Indiana
University of Indiana Medical Center, Indianapolis,  Indiana,  United States; Not yet recruiting
Tod Huntley, MD
Tod Huntley, MD,  Principal Investigator

Ohio
University Ear, Nose and Throat Specialists, Cincinnati,  Ohio,  45267-0528,  United States; Recruiting
Chris Canter, BA  513-558-1719    Christine.Canter@uc.edu 
Colleen Eigel, BS  513-558-1719    Colleen.Eigel@uc.edu 
David L Steward, MD,  Principal Investigator

Wisconsin
Department of OTO-HNS Medical College of Wisconsin, Milwaukee,  Wisconsin,  53022,  United States; Recruiting
Melissa Spadanuda  414-805-5553    MSpadan@mcw.edu 
Tucker Woodson, MD,  Principal Investigator

Study chairs or principal investigators

David L Steward, MD,  Principal Investigator,  University Ear, Nose and Throat Specialists   

More Information

Manufacturer's website for more information on Pillar Implants

Study ID Numbers:  05-08-14-1
Last Updated:  March 27, 2006
Record first received:  March 27, 2006
ClinicalTrials.gov Identifier:  NCT00307957
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2006-10-03





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