Study of the Pillar(R) Palatal Implants in Combination With Continuous Positive Airway Pressure (CPAP) Therapy for the Treatment of Obstructive Sleep Apnea (OSA) - Full Text View

Purpose

The study will be done for the following purposes:

to see if Pillar implants in combination with CPAP treatment can help people with their OSA by decreasing the CPAP pressures
to find out if receiving Pillar implants will increase CPAP use

Condition	Intervention	Phase
Obstructive Sleep Apnea (OSA)	Device: Pillar Palatal Implant System Device: Sham system	Phase IV

MedlinePlus related topics:

Sleep Apnea

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	Randomized Placebo-Controlled Study of the Pillar® Palatal Implant System With CPAP

Further study details as provided by Restore Medical, Inc.:

Primary Outcome Measures:

A ≥ 2 cmH2O reduction in titration of CPAP pressure as compared to placebo. [ Time Frame: 4 months post-procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Decrease in Visual Analog Scale (VAS) for CPAP comfort score. [ Time Frame: 4 months post-procedure ] [ Designated as safety issue: No ]

Enrollment:	52
Study Start Date:	November 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Pillar Implants	Device: Pillar Palatal Implant System The Pillar system is intended as an initial surgical treatment option for mild to moderate OSA. It consists of a delivery system and an implant. The delivery system is comprised of a disposable handle and needle assembly that allows for positioning and placement of the implants within the soft palate. The implant is a cylindrical shaped segment of braided polyester filaments that is intended for permanent implantation into the soft palate. 3 implants are placed per subject.
2: Sham Comparator Procedure but no implants inserted.	Device: Sham system The only difference between the treatment and placebo arm is that the placebo delivery device will not be pre-loaded with the implant. Otherwise the appearance, manufacturing and function of the devices are identical.

Detailed Description:

The Pillar® Palatal Implant System is designed to hold the airway open at night, thus avoiding obstruction. While the Pillar procedure can be effective in the treatment of mild to moderate OSA, its effect in combination with CPAP treatment has never been studied. In this study, the treatment of OSA using the Pillar procedure in combination with standard CPAP treatment vs. sham procedure in combination with standard CPAP treatment will be investigated. All subjects will be asked to continue their normal use of CPAP treatment during the study. The study will evaluate whether or not the Pillar implants allow less therapeutic pressure to be used in treating the OSA and if less pressure translates to increased usage.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

OSA documented by sleep study demonstrating AHI > 10, where hypopneas are defined by Medicare criteria requiring a 4% desaturation
Adequate CPAP therapy titration (residual AHI < 5) resulting in a therapeutic pressure ≥7 cm H20 from baseline PSG
Currently using or willing to change to Respironics CPAP device (without A-flex, C-flex and Bi-flex enabled) with SmartCard technology
Currently dissatisfied with CPAP therapy

Exclusion Criteria:

Uses full face mask
Soft palate length insufficient to accommodate 18mm implants as measured from the hard palate junction to the base of the uvula (<25 mm)
Drug abuse or alcoholism in the year prior to enrollment as assessed by history
Inconsistent use of sleeping medications (1 or 2 nights per week)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730041

Locations


United States, Arkansas
	Arkansas Center for Sleep Medicine
	Little Rock, Arkansas, United States, 72205

United States, California
	Alta Bates Summit Medical Center
	Berkeley, California, United States, 94704

United States, Colorado
	Sleep Center at National Jewish Medical Center
	Denver, Colorado, United States, 80206

United States, Louisiana
	Louisiana Sleep Foundation
	Baton Rouge, Louisiana, United States, 70809

United States, Minnesota
	Regions Hospital; Health Partners Sleep Health Center
	St. Paul, Minnesota, United States, 55101-2595

United States, New York
	NYU Sleep Disorders Center
	New York, New York, United States, 10016

United States, South Carolina
	Medical University of South Carolina
	Charleston, South Carolina, United States, 29425

Sponsors and Collaborators

Restore Medical, Inc.

Medtronic

Investigators


Principal Investigator:	David M Rapoport, MD	NYU Sleep Disorders Center

More Information

Responsible Party:	Restore Medical Inc. ( Joy Benson, CCRP )
Study ID Numbers:	845
First Received:	August 6, 2008
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00730041
Health Authority:	United States: Institutional Review Board

Keywords provided by Restore Medical, Inc.:

obstructive sleep apnea

continuous positive air pressure

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:

Nervous System Diseases

ClinicalTrials.gov processed this record on October 31, 2008

Sponsors and Collaborators:	Restore Medical, Inc. Medtronic
Information provided by:	Restore Medical, Inc.
ClinicalTrials.gov Identifier:	NCT00730041