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

This study has been completed.
Sponsor:
Collaborator:
Medtronic Xomed, Inc.
Information provided by:
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00307957
First received: March 27, 2006
Last updated: December 10, 2007
Last verified: December 2007
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Pillar Palatal Implant System Multi-Institutional, Randomized Placebo-Controlled Study for Obstructive Sleep Apnea

Resource links provided by NLM:


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
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, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

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

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

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014