Evaluation of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea

Completed · Not applicable

Conditions studied: Sleep Apnea, Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Sleep Disorder

In brief

This proof-of-concept study is being performed to evaluate whether the hypoglossal nerve can be stimulated using a small series of electrodes placed surgically via a percutaneous approach. Minimally invasive off the shelf medical devices will be used and observation of the characteristic physiological responses to stimulation of the HGN, will be assessed.

Key facts

Study ID

NCT06283030

Run by

Invicta Medical Inc.

People needed

14

Starts

2022-01-14

Expected to finish

2023-05-31

Last updated by the study team

2026-06-08

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject must be eligible for an OSA diagnostic or surgical procedure.
• Subject suffers with moderate to severe OSA based on history and a physical exam.
• Subject has failed, refused or has not tolerated CPAP treatment.
• Subject is willing and capable of providing informed consent.
• Subject is willing to have a representative electrode array temporarily placed in the submandibular, sublingual and mylohyoid space.
• -Subject is willing to participate in the designated follow-up visits.
• Subject must be in good general health.
• Subject is able to understand and has voluntarily signed and dated the IRB or EC approved informed consent form (ICF) prior to initiation of any screening or study-specific procedure.
• Subject must be minimum of 21 years and maximum 80 years of age.
• Subject's Hypoglossal Nerve must be able to be visualized using ultrasound

You may not qualify if…

• Subject has Body Mass Index above 38kg/m2.
• Subject has had surgical resection or radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat.
• Subject has significant co-morbidities making them unable or inappropriate to participate in this POC study.
• Subject plans to become pregnant, is currently pregnant or breastfeeding during the study period.

Where it is running

• Vanderbilt Bill Wilkerson Centre — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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