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

This study has been completed.

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

MedlinePlus related topics:   Sleep Apnea  

U.S. FDA Resources

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 Outcome Measures:
  • Daytime Sleepiness (ESS)
  • Apnea/Hypopnea Index (AHI)

Secondary Outcome Measures:
  • Sleep Related Quality of Life (FOSQ)
  • Reaction Time Testing (PVT)
  • Other polysomnographic parameters (AI, HI, RERArl, Arl, LSat)

Estimated Enrollment:   100
Study Start Date:   October 2005
Study Completion Date:   October 2006

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00307957

Locations
United States, Indiana
University of Indiana Medical Center    
      Indianapolis, Indiana, United States
United States, Ohio
University Ear, Nose and Throat Specialists    
      Cincinnati, Ohio, United States, 45267-0528
United States, Wisconsin
Department of OTO-HNS Medical College of Wisconsin    
      Milwaukee, Wisconsin, United States, 53022

Sponsors and Collaborators
University of Cincinnati
Restore Medical

Investigators
Principal Investigator:     David L Steward, MD     University Ear, Nose and Throat Specialists    
  More Information

Manufacturer's website for more information on Pillar Implants  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   05-08-14-1
First Received:   March 27, 2006
Last Updated:   December 10, 2007
ClinicalTrials.gov Identifier:   NCT00307957
Health Authority:   United States: Institutional Review Board

Keywords provided by University of Cincinnati:
Obstructive Sleep Apnea  
Daytime Sleepiness  
Pillar Palatal Implants  

Study placed in the following topic categories:
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Sleep Apnea, Obstructive
Dyssomnias
Sleep Disorders
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:
Signs and Symptoms
Respiratory Tract Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 03, 2008




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