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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00307957
Recruitment Status : Completed
First Posted : March 28, 2006
Last Update Posted : December 12, 2007
Medtronic Xomed, Inc.
Information provided by:
University of Cincinnati

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: Pillar Palatal Implants Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Pillar Palatal Implant System Multi-Institutional, Randomized Placebo-Controlled Study for Obstructive Sleep Apnea
Study Start Date : October 2005
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Primary Outcome Measures :
  1. Daytime Sleepiness (ESS)
  2. Apnea/Hypopnea Index (AHI)

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00307957

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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
Medtronic Xomed, Inc.
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Principal Investigator: David L Steward, MD University Ear, Nose and Throat Specialists
Additional Information:
Layout table for additonal information Identifier: NCT00307957    
Other Study ID Numbers: 05-08-14-1
First Posted: March 28, 2006    Key Record Dates
Last Update Posted: December 12, 2007
Last Verified: December 2007
Keywords provided by University of Cincinnati:
Obstructive Sleep Apnea
Daytime Sleepiness
Pillar Palatal Implants
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases