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

This study has been completed.
Information provided by University of Cincinnati

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Descriptive Information Fields
Brief Title  Study to Determine the Effectiveness of Pillar Palatal Implants to Treat Obstructive Sleep Apnea
Official Title  Pillar Palatal Implant System Multi-Institutional, Randomized Placebo-Controlled Study for Obstructive Sleep Apnea
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 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.

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 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 Phase Phase IV
Study Type  Interventional
Study Design  Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Daytime Sleepiness (ESS)
Apnea/Hypopnea Index (AHI)
Secondary Outcome Measure  Sleep Related Quality of Life (FOSQ)
Reaction Time Testing (PVT)
Other polysomnographic parameters (AI, HI, RERArl, Arl, LSat)
Condition  Obstructive Sleep Apnea
Intervention  Device: Pillar Palatal Implants
MEDLINE PMIDs
Links Manufacturer's website for more information on Pillar Implants This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  100
Start Date  October 2005
Completion Date October 2006
Eligibility 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00307957
Organization ID 05-08-14-1
Secondary IDs ††
Study Sponsor  University of Cincinnati
Collaborators †† Restore Medical, Inc.
Investigators 
Principal Investigator:     David L Steward, MD     University Ear, Nose and Throat Specialists    
Information Provided By University of Cincinnati
Verification Date December 2007
First Received Date  March 27, 2006
Last Updated Date December 10, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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