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 stimulation of the hypoglossal nerve
Sponsors
Invicta Medical Inc.
Adelaide Institute for Sleep Health, Flinders University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target identification and access outcomes | Day 0 | 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 lead placement 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. |
| Lead 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
Australia
Outcome results
None listed