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

NCT ID: NCT06283017

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2024-03-31

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 Disorder; Sleep Apnea Syndromes

Study Design

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

Study Groups

Hypoglossal nerve stimulation

Device-mediated stimulation of the hypoglossal nerve

Group Type: EXPERIMENTAL

Hypoglossal nerve stimulation

Intervention Type: DEVICE

Device stimulation of the hypoglossal nerve

Interventions

Hypoglossal nerve stimulation

Device stimulation of the hypoglossal nerve

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Adelaide Institute for Sleep Health, Flinders University

UNKNOWN

Sponsor Role: collaborator

Invicta Medical Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Adelaide Institute for Sleep Health, Flinders University

Adelaide, South Australia, Australia

Countries

Australia

Other Identifiers

IM-002

Identifier Type: -

Identifier Source: org_study_id