Evaluation of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea

Invicta Medical

Status: Completed

Conditions: Sleep Apnea Syndromes; Sleep Disorder; Sleep Apnea, Obstructive; Sleep Apnea

Treatments: Device: Hypoglossal nerve stimulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06283030

IM-001

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Hypoglossal nerve stimulation

Experimental group

Treatment:

Device: Hypoglossal nerve stimulation