Inspire® Post-Approval Study / Protocol Number 2014-001



Status:Recruiting
Conditions:Insomnia Sleep Studies, Pulmonary
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:22 - Any
Updated:2/28/2019
Start Date:May 2015
End Date:December 2021
Contact:Amy Geis
Email:amygeis@inspiresleep.com
Phone:763-957-5035

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Inspire® Upper Airway Stimulation System (UAS): Post-Approval Study Protocol Number 2014-001

The purpose of this study is to obtain additional long-term safety and efficacy data on the
use of Inspire therapy.

This is a multi-center, prospective, single-arm study conducted under a common protocol. Each
subject will serve as their own control. Each subject will be followed for 5 years from date
of implant.

Potential study subjects will be considered for study participation and consented once
pre-implant screening and implant qualification process have been completed. This includes an
in-lab PSG, surgical consultation, and a drug-induced sleep endoscopy procedure.

This study will collect pre-operative baseline data including, verification of ineffective
CPAP treatment, PSG information, medical history and subject quality of life measures. Intra-
and post- operative procedure data will be collected.

Post-implant, procedure- and device-related adverse events, QoL questionnaires, Functional
Tongue Exam, therapy usage and device adjustment data will be collected. In-lab PSG sleep
study data will be collected during the 2-month and 1 & 3 year follow-up visits, home sleep
tests will be conducted and data collected at the 6-month and 2, 4, & 5 year follow-up
visits.

The subject population will consist of otherwise healthy men and women that are at least 22
years old and have: 1) Provided written informed consent to participate, 2) Indicated a
willingness to comply with the study requirements for the specified follow-up duration, and
3) Met all inclusion and exclusion criteria of this protocol.

Up to 127 subjects will be implanted at a minimum of 10 and a maximum of 20 qualified sites
in the United States.

Inclusion Criteria:

1. Likely suffer moderate-to-severe OSA based on history and physical or have an
established diagnosis of OSA (20≤AHI≤65) based on a prior in-lab Polysomnography

2. Documentation the subject not effectively treated with CPAP therapy. (Examples include
non-compliance, discomfort, undesirable side effects, symptoms persist despite use).
Subjects who have been prescribed, but refuse to try CPAP would be considered
intolerant.

3. Age 22 or above

4. Willing and capable to have stimulation hardware permanently implanted, and to use the
patient remote to activate the stimulation

5. Willing and capable to return for all follow-up visits and conduct sleep studies at
home, including the evaluation procedures and filling out questionnaires

6. Willing and capable of providing informed consent

Exclusion Criteria:

Contraindications:

1. Central + mixed apneas > 25% of the total apnea-hypopnea index (AHI)

2. Any anatomical finding that would compromise the performance of upper airway
stimulation, such as the presence of complete concentric collapse of the soft palate

3. Any condition or procedure that has compromised neurological control of the upper
airway

4. Patients who are unable or do not have the necessary assistance to operate the patient
remote

5. Patients who are pregnant or plan to become pregnant

6. Patients who will require magnetic resonance imaging (MRI)

7. Patients with an implantable device that may be susceptible to unintended interaction
with the Inspire system.

Additional exclusions for study purposes only:

1. Body Mass Index (BMI) of > 32

2. Any chronic medical illness or condition that contraindicates a surgical procedure
under general anesthesia, as judged by the clinical study Investigator

3. Has a terminal illness with life expectancy < 12 months

4. Active psychiatric disease (psychotic illness, major depression, or acute anxiety
attacks) which prevents subject compliance with the requirements of the
investigational study testing

5. Any other reason the investigator deems subject is unfit for participation in the
study
We found this trial at
15
sites
3100 Southwest 62nd Avenue
Miami, Florida 33143
Principal Investigator: Jeremy Tabak, MD
Phone: 786-662-4443
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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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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,...
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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Birmingham, Alabama 35233
Principal Investigator: Kirk Withrow, MD
Phone: 205-934-9714
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Birmingham, AL
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: M. Boyd Gillespie, MD
Phone: 843-792-7076
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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2139 Auburn Ave
Cincinnati, Ohio 45219
(513) 585-2000
Principal Investigator: Joseph Hellmann, MD
Phone: 513-585-2094
The Christ Hospital For more than 120 years, The Christ Hospital has been a leader...
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Cincinnati, OH
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Cleveland, Ohio 44106
Principal Investigator: Kingman Strohl, MD
Phone: 216-844-2386
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Cleveland, OH
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Tina Waters, MD
Phone: 216-445-1698
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: Suzanne Stevens, MD
Phone: 913-945-7919
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Louisville, Kentucky 40217
Principal Investigator: David Winslow, MD
Phone: 502-479-1217
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Louisville, KY
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New York, New York 10065
Principal Investigator: Maria Suurna, MD
Phone: 646-962-5399
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Philadelphia, Pennsylvania 19104
Principal Investigator: Richard J Schwab, MD
Phone: 732-789-8562
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111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Maurtis Boone, 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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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Ryan Soose, MD
Phone: 412-232-8488
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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