Evaluation of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea

Not Applicable

Completed

• Conditions: Sleep Apnea Syndromes; Sleep Apnea; Sleep Disorder; Sleep Apnea, Obstructive
• Interventions: Device: Hypoglossal nerve stimulation

• Registration Number: NCT06283030
• Lead Sponsor: Invicta Medical Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-01
• Primary Completion: 2023-09-25
• Study Completion: 2023-09-25
• Status Verified: 2024-02
• Study First Submitted: 2024-02-13
• Study First Submitted QC: 2024-02-21
• Study First Posted: 2024-02-28
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hypoglossal nerve stimulation	Hypoglossal nerve stimulation	-

Primary Outcome Measures

Name	Time	Method
Identification and access of the target outcomes	Day 0	Consistent identification of and access to the target stimulation location aligned with the medial branch of the Hypoglossal Nerve.
Tongue protrusion outcomes	Day 0	Visual verification of protrusion of the tongue during stimulation at the target stimulation location with a representative electrode array.
Characterization of electrode array outcomes	Day 0	Spatial characterization of the orientation of the electrode array and lead body to the target stimulation location considering suitable chronic anchoring locations.
Electrode array placement and removal outcomes	Day 0	To demonstrate the ability to safely place and remove the electrode array, per protocol instructions.
Safety outcomes	Day 30	To evaluate and report all observed adverse events, serious adverse events, unanticipated adverse events and adverse device effects observed during the study

Trial Locations

Locations (1)

Vanderbilt Bill Wilkerson Centre; 🇺🇸 Nashville, Tennessee, United States