Clinical trial NCT06635265: A Study to Determine the Flow Changes And/or AHI Reduction When Stimulating Two Targets (neural And/or Muscular) for the Treatment of Obstructive Sleep Apnea in Adult Subjects
Official title: Single Center Proof-of-Concept Study to Determine the Flow Changes And/or AHI Reduction When Stimulating Two Targets (neural And/or Muscular) for the Treatment of Obstructive Sleep Apnea in Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Sleep Disorder
Keywords: Sleep Apnea device
Lead sponsor: Invicta Medical Inc.
Sponsor class: INDUSTRY
Collaborators: name: Hollywood Private Hospital
First posted: 2024-10-10
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Impacts on acute airway opening
timeFrame: Day 0 to 3
measure: Impacts on airflow during a acute assessment
timeFrame: Day 0 to 3
Secondary outcomes:
measure: Impacts on airway opening during a sub-acute assessment
timeFrame: Day 0 to 3
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Perth Head and Neck Surgery
state: Western Australia
Study officials:
References: