Evaluation of the Effects 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: Active, not recruiting

Administrative data

• NCT number: NCT06283017
• Other study ID #: IM-002
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: March 2024

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: Active, not recruiting
• Enrollment: 14
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Australia	Adelaide Institute for Sleep Health, Flinders University	Adelaide	South Australia

Sponsors (2)

Lead Sponsor	Collaborator
Invicta Medical Inc.	Adelaide Institute for Sleep Health, Flinders University

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target identification and access outcomes	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 lead placement 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	Lead 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