Evaluation of the Effects of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea

Not Applicable

Active, not recruiting

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

• Registration Number: NCT06283017
• 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: 2022-06-01
• Status Verified: 2024-02
• Study First Submitted: 2024-02-13
• Study First Submitted QC: 2024-02-21
• Study First Posted: 2024-02-28
• Primary Completion: 2024-03
• Study Completion: 2024-03
• Last Update Submitted: 2024-03-10
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

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

Inclusion Criteria

Subject must be eligible for a diagnostic or surgical procedure and

• Suffers from OSA (apnea/hypopnea index >10 event/h sleep) based on history and a physical exam.
• Is a surgical candidate.
• Is willing and capable of providing informed consent.
• Is willing to have a representative electrode array temporarily placed in the submandibular and mylohyoid space.
• Is willing to participate in the designated follow-up visits.
• Must be in good general health.
• 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.
• Must be minimum of 18 years and maximum 80 years of age.

Exclusion Criteria

• Has Body Mass Index above 35 kg/m2.
• Has had surgical resection or radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat.
• Has significant co-morbidities making them unable or inappropriate to participate in this POC study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hypoglossal nerve stimulation	Hypoglossal nerve stimulation	Device-mediated stimulation of the hypoglossal nerve

Primary Outcome Measures

Name	Time	Method
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
Characterization of lead placement 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.
Lead placement and removal outcomes	Day 0	To demonstrate the ability to safely place and remove the electrode array, per protocol instructions.
Target identification and access outcomes	Day 0	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.

Trial Locations

Locations (1)

Adelaide Institute for Sleep Health, Flinders University; 🇦🇺 Adelaide, South Australia, Australia