Hypoglossal Nerve Stimulation for the Treatment of Adult Obstructive Sleep Apnea

Launched by XII MEDICAL · Jun 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for adults with moderate to severe obstructive sleep apnea (OSA), a condition where breathing repeatedly stops and starts during sleep. The treatment involves implanting a small device called a Neurostimulator that sends gentle electrical signals to a nerve in the tongue (the hypoglossal nerve) to help keep the airway open while sleeping. This device is used at home, and participants will take part in sleep studies to see how well the treatment is working and to ensure it is safe.

People who might be eligible for this study are adults with a body weight within a certain range (a Body Mass Index of 32 or less) who have moderate to severe sleep apnea but have not been able to use or did not benefit from standard treatments like CPAP machines. Participants should not have other serious medical conditions that would make surgery unsafe or conditions that affect breathing patterns differently. If accepted into the study, participants will have the device implanted and will be closely monitored throughout the study to track their sleep quality and overall response to the treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Body Mass Index (BMI) ≤ 32 kg/m2
• • AHI of 15-50 events/hour
• • Central + mixed apnea index ≤ 25%
• • Participants who have either not tolerated, have failed or refused positive airway pressure (PAP)
• Exclusion Criteria:
• • Pregnancy or breast-feeding.
• • Significant upper airway anatomic abnormalities
• • Hypoglossal nerve weakness
• • Central sleep apnoea condition
• • Significant positionally-dependent OSA.
• • Complete concentric patterns of soft palate collapse on DISE
• • Inadequately treated non-OSA sleep disorder(s).
• • Significant co-morbidities or prior surgeries that contra-indicate a surgical procedure or general anesthesia
• • Taking medications that in the opinion of the investigator may alter consciousness, the pattern of respiration, or sleep architecture
• • Participants on a GLP-1