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

Invicta Medical

Status

Active, not recruiting

Conditions

Sleep Apnea Syndromes

Sleep Disorder

Sleep Apnea, Obstructive

Sleep Apnea

Treatments

Device: Hypoglossal nerve stimulation

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT06283017

IM-002

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

18 to 80 years old

Volunteers

No Healthy Volunteers

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.