A Study to Investigate the Feasibility and Respiratory Effects of Stimulating Two Functional Targets (neural And/or Muscular) for the Treatment of Obstructive Sleep Apnea

Launched by INVICTA MEDICAL INC. · Oct 2, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for obstructive sleep apnea (OSA), a condition where breathing repeatedly stops and starts during sleep. The study aims to see how well stimulating certain nerves and muscles in the throat can improve breathing and airflow when people are asleep. Participants will undergo a procedure called Drug Induced Sleep Endoscopy (DISE) to place small electrode arrays that will help measure changes in airflow. They'll also have their sleep monitored overnight to better understand how these stimulations affect their breathing and sleep quality.

To be eligible for this trial, participants must be at least 18 years old, have a Body Mass Index (BMI) under 35, and have a documented diagnosis of OSA. They should not have any major health issues or previous surgeries that could affect the study. Those who join the trial will receive detailed information about what to expect, including the procedures involved and any lifestyle considerations. It's important that participants are willing to follow the study requirements and provide informed consent before taking part.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• A subject 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) \< 35 kg/m2.
• • OSA (15 \< AHI \< 80 events/h sleep) documented by a sleep study performed during the past 24 months in the absence of any major weight change or other medical issues.
• • Subject must be eligible for a diagnostic DISE or surgical procedure (acute study measures only).
• • Written informed consent obtained from the subject 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:
• Subjects 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/DISE
• • Significant tongue weakness
• • Any other chronic medical illness or condition that contraindicates a surgical procedure or general anesthesia/DISE 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