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Ansa Cervicalis and Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea

This study is investigating new ways to treat Obstructive Sleep Apnea (OSA), a condition where breathing repeatedly stops and starts during sleep. Researchers are testing the Grass S88 Muscle Stimulator, a device that stimulates nerves and muscles, to see how stimulating the ansa cervicalis nerve, alone or with the hypoglossal nerve, affects the airway during sleep. They believe that stimulating the ansa cervicalis might help open the airway by pulling on the windpipe. The study aims to enroll 100 adults, aged 18 and older, with OSA (AHI between 20-80 events/hr) and a BMI between 25 and 40. Success will be measured by changes in airway size, airflow, and pressure during a drug-induced sleep endoscopy (DISE). The current recruitment status is unclear.

Study design
This interventional study plans to enroll 100 participants. The phase of the study is not specified.
What's involved
During the DISE and a second sleep study, fine-wire electrodes will be placed into the hypoglossal nerve or genioglossus muscle. Basic physiologic measurements will be taken during DISE for approximately 15 minutes.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT05501236

Ansa Cervicalis and Hypoglossal Nerve Stimulation in OSA

Recruiting
NAAges 18+InterventionalBasic science
Vanderbilt University Medical Center
~100 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:Grass S88 Muscle Stimulator

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Basic physiologic measurements during Drug Induced Sleep Endoscopy (DISE) - Airway cross sectional diameter
Measured over During DISE, approximately 15 minutes
+10 more outcomes measured

Conditions

Obstructive Sleep Apnea

Explore related trials

Obstructive Sleep Apnea

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • David T. Kent, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center

Who to contact

Katie Hartley-Estes, RPSGT
[email protected]
615-875-9214
Email the study team

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What this trial measures

  • Basic physiologic measurements during Drug Induced Sleep Endoscopy (DISE) - Airway cross sectional diameterDuring DISE, approximately 15 minutes

    Airway cross-sectional diameter (mm\^2) will be measured throughout the operative procedure via flexible fiberoptic nasopharyngoscopy.

  • Basic physiologic measurements during Drug Induced Sleep Endoscopy (DISE) - Airflow dataDuring DISE, approximately 15 minutes

    Airflow data (L/min) will be measured throughout the operative procedure via a pneumotachometer applied to the nose.

  • Basic physiologic measurements during Drug Induced Sleep Endoscopy (DISE) - Upper airway pressure changesDuring DISE, approximately 15 minutes

    Upper airway pressure changes (cmH20) will be measured throughout the operative procedure via a pneumotachometer applied to the nose.

  • Basic physiologic measurements during Drug Induced Sleep Endoscopy (DISE) - Respiratory effort dataDuring DISE, approximately 15 minutes

    Respiratory effort data (mV) will be measured throughout the operative procedure via two respiratory inductance plethysmography belts.

  • Basic physiologic measurements during Polysomnography (PSG) - Airflow dataDuring sleep study exam (PSG), approximately 8 hours

    Airflow data (L/min) will be measured during the sleep study via a pneumotachometer applied to the nose.

  • Basic physiologic measurements during Polysomnography (PSG) - Electroencephalogram (EEG)During sleep study exam (PSG), approximately 8 hours

    EEG (mV) will be collected during the sleep study via skin surface electrodes.

  • Basic physiologic measurements during Polysomnography (PSG) - Electrocardiogram (EKG)During sleep study exam (PSG), approximately 8 hours

    EKG (mV) will be collected during the sleep study via skin surface electrodes.

  • Basic physiologic measurements during Polysomnography (PSG) - Electroocoulogram (EOG)During sleep study exam (PSG), approximately 8 hours

    EOG (mV) will be collected during the sleep study via skin surface electrodes.

  • Basic physiologic measurements during Polysomnography (PSG) - Electromyography (EMG)During sleep study exam (PSG), approximately 8 hours

    EMG data (mV) will be collected during the sleep study via skin surface electrodes.

  • Basic physiologic measurements during Polysomnography (PSG) - Respiratory effort dataDuring sleep study exam (PSG), approximately 8 hours

    Respiratory effort data (mV) will be collected during the sleep study via respiratory inductance plethysmography.

  • Basic physiologic measurements during Polysomnography (PSG) - Video dataDuring sleep study exam (PSG), approximately 8 hours

    Video data will be collected during the sleep study via in-room camera.