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

Status unconfirmed · Not applicable

Conditions studied: Obstructive Sleep Apnea

In brief

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

Key facts

Study ID

NCT02413970

Run by

Inspire Medical Systems, Inc.

People needed

127

Starts

2015-05-01

Expected to finish

2025-06-01

Last updated by the study team

2024-12-27

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Likely suffer moderate-to-severe OSA based on history and physical or have an established diagnosis of OSA (AHI >= 15) based on a prior sleep study
• 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.
• Age 22 or above
• Willing and capable to have stimulation hardware permanently implanted, and to use the patient remote to activate the stimulation
• Willing and capable to return for all follow-up visits and conduct sleep studies at home, including the evaluation procedures and filling out questionnaires
• Willing and capable of providing informed consent

You may not qualify if…

• Contraindications:
• Central + mixed apneas > 25% of the total apnea-hypopnea index (AHI)
• Any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate
• Any condition or procedure that has compromised neurological control of the upper airway
• Patients who are unable or do not have the necessary assistance to operate the patient remote
• Patients who are pregnant or plan to become pregnant
• Patients who will require magnetic resonance imaging (MRI)
• Patients with an implantable device that may be susceptible to unintended interaction with the Inspire system.
• Additional exclusions for study purposes only:
• Any chronic medical illness or condition that contraindicates a surgical procedure under general anesthesia, as judged by the clinical study Investigator
• Has a terminal illness with life expectancy < 12 months
• Active psychiatric disease (psychotic illness, major depression, or acute anxiety attacks) which prevents subject compliance with the requirements of the investigational study testing
• Any other reason the investigator deems subject is unfit for participation in the study

Where it is running

• The University of Alabama at Birmingham Medical Center — Birmingham, Alabama, United States
• University of Southern California — Los Angeles, California, United States
• South Miami Hospital — Miami, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• The University of Kansas Medical Center — Kansas City, Kansas, United States
• Kentucky Research Group — Louisville, Kentucky, United States
• Weill Cornell Medicine — New York, New York, United States
• The Christ Hospital — Cincinnati, Ohio, United States
• University Hospitals — Cleveland, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• University of Pennsylvania, Division of Sleep Medicine — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University and Hospital — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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