Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea on Sympathetic and Vascular Function

  • STATUS
    Enrolling By Invitation
  • participants needed
    60
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Updated on 9 May 2025

Summary

The hypoglossal nerve controls tongue movement. The Inspire® sleep implant works by stimulating this nerve. This process is called hypoglossal nerve stimulation, or “HGNS.” In this study, we are interested in seeing how HGNS affects blood pressure and heart-related measures and if it lowers the risk of heart problems in people with obstructive sleep apnea.

Description

If you decide to participate, we will test your cardiovascular function (described below) after a period of regular (“active”) Inspire treatment and after a period of very low (“sham therapy”) Inspire treatment. You will be blinded during both “sham” and “active” periods, which means that you will not be told which level of treatment you are having.

There will be 5 visits in total, which will take place on Days 1, 8, 36, 43, and 71.

We will also look in your medical record to collect information such as your age, sex, race, height, weight, whether you have been diagnosed with high blood pressure or diabetes, and the results of your routine care sleep tests, clinical follow-up visits, and other lab tests.

FAQ


Details
Condition Sleep Apnea,Obstructive Sleep Apnea,OSA,Hypoglossal Nerve Stimulation,HGNS,Inspire
Age 21years - 99years
Clinical Study Identifier03359096
Last Modified on9 May 2025

Eligibility

If you need help finding a study or have any questions, please contact us at psom-ocr@pobox.upenn.edu

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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