Evaluation of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea

Sleep Apnea Clinical Trial

Official title:

Acute Proof-of-Concept Study to Evaluate Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06283030
• Other study ID #: IM-001
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: September 25, 2023

Study information

• Verified date: February 2024
• Source: Invicta Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: September 25, 2023
• Est. primary completion date: September 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Device:
• Hypoglossal nerve stimulation
Device-mediated stimulation of the hypoglossal nerve

Locations

Country	Name	City	State
United States	Vanderbilt Bill Wilkerson Centre	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Invicta Medical Inc.	Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0
Primary	Tongue protrusion outcomes	Visual verification of protrusion of the tongue during stimulation at the target stimulation location with a representative electrode array.	Day 0
Primary	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.	Day 0
Primary	Electrode array placement and removal outcomes	To demonstrate the ability to safely place and remove the electrode array, per protocol instructions.	Day 0
Primary	Safety outcomes	To evaluate and report all observed adverse events, serious adverse events, unanticipated adverse events and adverse device effects observed during the study	Day 30