Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry



Status:Recruiting
Conditions:Insomnia Sleep Studies, Pulmonary
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:22 - Any
Updated:3/30/2019
Start Date:October 19, 2016
End Date:September 2025
Contact:Amy Geis
Email:amygeis@inspiresleep.com
Phone:763-957-5035

Use our guide to learn which trials are right for you!

Inspire intends to conduct this registry to: 1) collect Inspire therapy clinical evidence in
the clinical practice setting; 2) collect additional information on the effectiveness, use
and safety in the commercial setting; and 3) engage physician customers to report the
collective outcome within a group of properly trained programs that utilize Inspire therapy
on a regular basis.

In addition, a sub-study will be conducted under this Registry at a limited number of
Registry centers and will include a cohort of Registry patients and a cohort of patients who
have not received the Inspire therapy device due to denial of insurance coverage. The two
sub-study cohorts' quality of life and AHI data will be compared.

This registry is a multi-center, prospective, observational registry, conducted in the United
States and Europe. Some data may be collected retrospectively in patients currently implanted
(implanted prior to enrollment) through the 12-month follow-up time frame. The CE-marked and
FDA-approved Inspire system will be used within its intended use, allowing for of use of any
future approved system component models. This protocol does not include any additional
stressful or invasive tests, which are not a part of standard of care.

Inclusion Criteria:

Any patient implanted with or receiving an Inspire implant, who meets the following
criteria, is eligible to participate in the registry:

1. Must be a legal adult

2. Capable of giving informed consent, as required per institution

3. Willing to return for routine clinic visits as required for Inspire therapy management

Exclusion Criteria:

Any patient who meets any of the following criteria will not be eligible to participate in
the registry

1. Has a life expectancy of less than 1 year

2. Any reason the clinician deems patient is unfit for participation in the study
We found this trial at
28
sites
340 W 10th St #6200
Indianapolis, Indiana 46202
(317) 274-3772
Principal Investigator: Shalini Manchanda, MD
Phone: 317-274-4363
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Tina Waters, MD
Phone: 216-445-1698
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Los Angeles, California 90033
213) 740-2311
Principal Investigator: Eric Kezirian, MD
Phone: 323-442-2151
University of Southern California The University of Southern California is one of the world’s leading...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Conrad Iber, MD
Phone: 612-625-1435
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: David Kent, MD
Phone: 615-322-0333
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Principal Investigator: Tapan Padhya, MD
Phone: 813-844-8153
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
?
mi
from
Tampa, FL
Click here to add this to my saved trials
13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Katherine Green, MD
Phone: 303-724-8465
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
?
mi
from
Aurora, CO
Click here to add this to my saved trials
1720 2nd Avenue South
Birmingham, Alabama 35294
Principal Investigator: Kirk Withrow, MD
Phone: 205-934-9714
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Shaun Nguyen, MD
Phone: 864-674-4132
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Phillip LoSavio, MD
Phone: 312-942-5083
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45220
Principal Investigator: Reena Dhandi-Patel, MD
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cleveland, Ohio 44106
Principal Investigator: Kingman Strohl, MD
Phone: 216-844-2386
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Eugene Chio, MD
Phone: 614-366-9244
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Gainesville, Florida 32608
Principal Investigator: John Harwick, MD
Phone: 352-294-5685
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: Christopher Larsen, MD
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
Louisville, Kentucky 40207
Principal Investigator: Andrew Gould, MD
Phone: 502-893-0159
?
mi
from
Louisville, KY
Click here to add this to my saved trials
160 Ratzeburger Allee
Lubeck, 23562
Principal Investigator: Armin Steffen, PD Dr. med.
?
mi
from
Lubeck,
Click here to add this to my saved trials
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: B. Tucker Woodson, MD
Phone: 414-955-2670
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
New Haven, Connecticut
Principal Investigator: Mark D'Agonstino, MD
?
mi
from
New Haven, CT
Click here to add this to my saved trials
New York, New York 10065
Principal Investigator: Maria Suurna, MD
Phone: 646-962-5399
?
mi
from
New York, NY
Click here to add this to my saved trials
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Richard Schwab, MD
Phone: 267-551-1164
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Maurits Boon, MD
Phone: 215-503-6828
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
800 Spruce St
Philadelphia, Pennsylvania 19107
215-829-3000
Principal Investigator: James Kearney, MD
Phone: 215-615-1611
Pennsylvania Hospital Pennsylvania Hospital, the nation's first hospital, has been a leader in patient care,...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Ryan Soose, MD
Phone: 412-232-7207
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Redwood City, California 94063
Principal Investigator: Clete Kushida, MD
Phone: 650-721-7574
?
mi
from
Redwood City, CA
Click here to add this to my saved trials
Richmond, Virginia 23298
(804) 828-0100
Principal Investigator: Ryan Nord, MD
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Saint Cloud, Minnesota 56303
Principal Investigator: Ronald Hanson, MD
Phone: 320-492-7290
?
mi
from
Saint Cloud, MN
Click here to add this to my saved trials
Washington, District of Columbia
Principal Investigator: Stanley H. Chia, MD
Phone: 202-877-0486
?
mi
from
Washington,
Click here to add this to my saved trials