Back to resultsStudy to Determine the Effectiveness of Pillar Palatal Implants to Treat Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pillar Palatal Implants
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive Sleep Apnea, Daytime Sleepiness, Pillar Palatal Implants
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
Sites / Locations
- University of Indiana Medical Center
- University Ear, Nose and Throat Specialists
- Department of OTO-HNS Medical College of Wisconsin
Outcomes
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)
Full Information
NCT ID
NCT00307957
First Posted
March 27, 2006
Last Updated
December 10, 2007
Sponsor
University of Cincinnati
Collaborators
Medtronic Xomed, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00307957
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Cincinnati
Collaborators
Medtronic Xomed, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Obstructive Sleep Apnea, Daytime Sleepiness, Pillar Palatal Implants
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Pillar Palatal Implants
Primary Outcome Measure Information:
Title
Daytime Sleepiness (ESS)
Title
Apnea/Hypopnea Index (AHI)
Secondary Outcome Measure Information:
Title
Sleep Related Quality of Life (FOSQ)
Title
Reaction Time Testing (PVT)
Title
Other polysomnographic parameters (AI, HI, RERArl, Arl, LSat)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David L Steward, MD
Organizational Affiliation
University Ear, Nose and Throat Specialists
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Indiana Medical Center
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
University Ear, Nose and Throat Specialists
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0528
Country
United States
Facility Name
Department of OTO-HNS Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53022
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.restoremedical.com
Description
Manufacturer's website for more information on Pillar Implants
Learn more about this trial
Study to Determine the Effectiveness of Pillar Palatal Implants to Treat Obstructive Sleep Apnea
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