Sleep Apnea, Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Sleep Disorder
Conditions
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.
Interventions
Device-mediated stimulation of the hypoglossal nerve
Sponsors
Invicta Medical Inc.
Vanderbilt University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification and access of the target outcomes | Day 0 | Consistent 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. |
| Characterization of electrode array 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. |
| Electrode array placement and removal outcomes | Day 0 | To demonstrate the ability to safely place and remove the electrode array, per protocol instructions. |
| 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 |
Countries
United States
Outcome results
None listed