Sleep Apnea, Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Sleep Disorder
Conditions
Keywords
Sleep Apnea device
Brief summary
This Proof-of-Concept study will collect acute and sub-acute flow and/or AHI data following the placement of lead arrays under direct vision. The acute placement and data collection will be collected following the completion of the pre-scheduled neck dissection surgery. The sub-acute data will be collected in a sleep lab during a polysomnography (PSG). Both data collections will be done when stimulating (using an external pulse generator) the hypoglossal nerve or Genioglossus muscle (GG) and a second neural target (Ansa Cervicalis - AC) or the strap muscles (sternohyoid and sternothyroid) with a set of Off-the-Shelf (OTS) electrode arrays.
Interventions
Simulation of a combination of: HGN, AC, GG or strap muscles
Sponsors
Hollywood Private Hospital
Invicta Medical Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Electrode arrays placed adjacent to nerves are connected to an external pulse generator to evaluate the effect of short-term stimulation on airflow and/or AHI
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
A patient must meet all of the following inclusion criteria to be eligible for inclusion in this study: * Age above 18 years not under guardianship, under curatorship or under judicial protection. * Body Mass Index (BMI) \< 38 kg/m2. * Subject must be eligible for neck dissection surgery. * Written informed consent obtained from the patient prior to performing any study specific procedure. * Willing and capable to comply with all study requirements, including specific lifestyle considerations, evaluation procedures and questionnaires for the whole duration of the trial.
Exclusion criteria
Patients meeting any of the following criteria will be excluded from participation in this study: * Major anatomical or functional abnormalities that would impair the ability of the electrode arrays to be positioned. * Significant comorbidities that contraindicate surgery or general anesthesia. * Significant tongue weakness. * Aerodigestive tract tumor or reconstructive surgery performed at the same time as neck dissection. * Any other chronic medical illness or condition that contraindicates a surgical procedure or general anesthesia in the judgment of the investigator. * Prior surgery or treatments that could compromise the placement and effectiveness of the electrode array systems: * Airway cancer surgery or radiation, or * Mandible or maxilla surgery in the previous 3 years (not counting dental treatments). * Other upper airway surgery to remove obstructions related to OSA in the previous 3 months (e.g., uvulopalatopharyngoplasty (UPPP), tonsillectomy, nasal airway surgery). * Prior hypoglossal nerve stimulation device implantation. * Currently pregnant or breastfeeding during the study period. * Concomitant oral or pharyngeal surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impacts on acute airway opening | Day 0 to 3 | Demonstration of acute airway opening as visually observed under nasoendoscopy when stimulating the HGN or GG and a second target (neural or direct muscle stimulation). |
| Impacts on airflow during a acute assessment | Day 0 to 3 | Acute increase in airflow when stimulating the HGN or GG and a second target (neural or direct muscle stimulation), measured by changes in amplitude (mA) during target stimulation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impacts on airway opening during a sub-acute assessment | Day 0 to 3 | Demonstration of sub-acute flow increase and/or AHI reduction when stimulating two targets simultaneously during natural sleep as measured with polysomnography (PSG), measured by polysomnography. |
Countries
Australia
Outcome results
None listed