Evaluation of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea

NCT ID: NCT06283030

Last Updated: 2024-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2023-09-25

Brief Summary

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.

Conditions

Sleep Apnea; Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Sleep Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Hypoglossal nerve stimulation

Group Type: EXPERIMENTAL

Hypoglossal nerve stimulation

Intervention Type: DEVICE

Device-mediated stimulation of the hypoglossal nerve

Interventions

Hypoglossal nerve stimulation

Device-mediated stimulation of the hypoglossal nerve

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: collaborator

Invicta Medical Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Vanderbilt Bill Wilkerson Centre

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

IM-001

Identifier Type: -

Identifier Source: org_study_id