Proof-of-Concept Study to Determine the Flow Changes When Stimulating Two Neural Targets for the Treatment of Obstructive Sleep Apnea

Invicta Medical

Status

Active, not recruiting

Conditions

Sleep Apnea Syndromes

Sleep Disorder

Sleep Apnea, Obstructive

Sleep Apnea

Treatments

Device: Hypoglossal nerve and/or Ansa Cervicalis stimulation

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06415981

IM-003

Details and patient eligibility

About

This proof-of-concept study will evaluate the impact of surgically placing and stimulating the hypoglossal nerve and/or a second neural target Ansa Cervicalis, with a set of off-the-shelf electrode arrays.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age above 18 years not under guardianship, under curatorship or under judicial protection.
Body Mass Index (BMI) < 35 kg/m2.
Subject suffers from OSA (15 < AHI < 80) documented by a sleep study performed during the past 36 months.
Subject must be eligible for a diagnostic or surgical procedure.
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

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
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,
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