Study to Determine the Effectiveness of Pillar Palatal Implants to Treat Obstructive Sleep Apnea - Full Text View

Sponsors and Collaborators:	University of Cincinnati Medtronic Xomed, Inc.
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

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

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

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

Medtronic Xomed, Inc.

Investigators

Principal Investigator:

David L Steward, MD

University Ear, Nose and Throat Specialists

More Information

Additional Information:

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

No publications provided

Study ID Numbers:	05-08-14-1
Study First Received:	March 27, 2006
Last Updated:	December 10, 2007
ClinicalTrials.gov Identifier:	NCT00307957 History of Changes
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:

Signs and Symptoms
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders

Sleep Apnea, Obstructive
Dyssomnias
Sleep Disorders
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Signs and Symptoms
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Nervous System Diseases
Respiration Disorders

Sleep Apnea, Obstructive
Sleep Disorders
Dyssomnias
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on September 11, 2009