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

Tracking Information

First Received Date ^ICMJE

March 27, 2006

Last Updated Date

December 10, 2007

Start Date ^ICMJE

October 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Daytime Sleepiness (ESS)
Apnea/Hypopnea Index (AHI)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00307957 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Pillar Palatal Implant System Multi-Institutional, Randomized Placebo-Controlled Study for Obstructive Sleep Apnea

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Obstructive Sleep Apnea

Intervention ^ICMJE

Device: Pillar Palatal Implants

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

100

Completion Date

October 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00307957

Responsible Party

Study ID Numbers ^ICMJE

05-08-14-1

Study Sponsor ^ICMJE

University of Cincinnati

Collaborators ^ICMJE

Medtronic Xomed, Inc.

Investigators ^ICMJE

Principal Investigator:

David L Steward, MD

University Ear, Nose and Throat Specialists

Information Provided By

University of Cincinnati

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP