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 |
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.
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.
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
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9500 Euclid Avenue
Cleveland, Ohio 44106
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...
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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...
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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...
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1211 Medical Center Dr
Nashville, Tennessee 37232
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...
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1 Tampa General Cir
Tampa, Florida 33606
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,...
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13001 E. 17th Pl
Aurora, Colorado 80045
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...
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1720 2nd Avenue South
Birmingham, Alabama 35294
Birmingham, Alabama 35294
Principal Investigator: Kirk Withrow, MD
Phone: 205-934-9714
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171 Ashley Avenue
Charleston, South Carolina 29425
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...
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1653 W. Congress Parkway
Chicago, Illinois 60612
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...
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Cleveland, Ohio 44106
Principal Investigator: Kingman Strohl, MD
Phone: 216-844-2386
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281 W. Lane Ave
Columbus, Ohio 43210
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...
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Gainesville, Florida 32608
Principal Investigator: John Harwick, MD
Phone: 352-294-5685
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340 W 10th St #6200
Indianapolis, Indiana 46202
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...
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3901 Rainbow Blvd
Kansas City, Kansas 66160
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...
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Louisville, Kentucky 40207
Principal Investigator: Andrew Gould, MD
Phone: 502-893-0159
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160 Ratzeburger Allee
Lubeck, 23562
Lubeck, 23562
Principal Investigator: Armin Steffen, PD Dr. med.
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
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...
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New York, New York 10065
Principal Investigator: Maria Suurna, MD
Phone: 646-962-5399
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3451 Walnut St
Philadelphia, Pennsylvania 19104
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...
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111 S 11th St
Philadelphia, Pennsylvania 19107
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...
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800 Spruce St
Philadelphia, Pennsylvania 19107
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,...
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
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...
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Redwood City, California 94063
Principal Investigator: Clete Kushida, MD
Phone: 650-721-7574
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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...
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Saint Cloud, Minnesota 56303
Principal Investigator: Ronald Hanson, MD
Phone: 320-492-7290
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Washington, District of Columbia
Principal Investigator: Stanley H. Chia, MD
Phone: 202-877-0486
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