Evaluation of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea

Invicta Medical Inc.14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Sleep Apnea Sleep Apnea, Obstructive Sleep Apnea Syndromes Sleep Disorder

Interventions

Hypoglossal nerve stimulationDEVICE

Device-mediated stimulation of the hypoglossal nerve

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Locations (1)

Vanderbilt Bill Wilkerson Centre

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Identification and access of the target outcomes

Consistent identification of and access to the target stimulation location aligned with the medial branch of the Hypoglossal Nerve.

Time frame: Day 0

Tongue protrusion outcomes

Visual verification of protrusion of the tongue during stimulation at the target stimulation location with a representative electrode array.

Time frame: Day 0

Characterization of electrode array outcomes

Spatial characterization of the orientation of the electrode array and lead body to the target stimulation location considering suitable chronic anchoring locations.

Time frame: Day 0

Electrode array placement and removal outcomes

To demonstrate the ability to safely place and remove the electrode array, per protocol instructions.

Time frame: Day 0

Safety outcomes

To evaluate and report all observed adverse events, serious adverse events, unanticipated adverse events and adverse device effects observed during the study

Time frame: Day 30

Data from ClinicalTrials.gov

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