Ansa Cervicalis and Hypoglossal Nerve Stimulation in OSA

NCT05501236 | Recruiting DMC

• 1 other identifier: 212305
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Polysomnography (PSG) and drug-induced sleep endoscopy (DISE) are widely used diagnostic studies for assessing obstructive sleep apnea (OSA) severity and collapse patterns of the upper airway anatomy during sleep. Hypoglossal nerve stimulation (HNS) therapy for obstructive sleep apnea suffers from variable response at the level of the soft palate. The Investigators propose a study examining the physiologic effect of ansa cervicalis stimulation (ACS) alone and in combination with HNS during PSG and DISE.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (11)

• Basic physiologic measurements during Drug Induced Sleep Endoscopy (DISE) - Airway cross sectional diameter

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

  During DISE, approximately 15 minutes

• Basic physiologic measurements during Drug Induced Sleep Endoscopy (DISE) - Airflow data

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

  During DISE, approximately 15 minutes

• Basic physiologic measurements during Drug Induced Sleep Endoscopy (DISE) - Upper airway pressure changes

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

  During DISE, approximately 15 minutes

• Basic physiologic measurements during Drug Induced Sleep Endoscopy (DISE) - Respiratory effort data

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

  During DISE, approximately 15 minutes

• Basic physiologic measurements during Polysomnography (PSG) - Airflow data

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

  During sleep study exam (PSG), approximately 8 hours

• Basic physiologic measurements during Polysomnography (PSG) - Electroencephalogram (EEG)

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

  During sleep study exam (PSG), approximately 8 hours

• Basic physiologic measurements during Polysomnography (PSG) - Electrocardiogram (EKG)

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

  During sleep study exam (PSG), approximately 8 hours

• Basic physiologic measurements during Polysomnography (PSG) - Electroocoulogram (EOG)

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

  During sleep study exam (PSG), approximately 8 hours

• Basic physiologic measurements during Polysomnography (PSG) - Electromyography (EMG)

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

  During sleep study exam (PSG), approximately 8 hours

• Basic physiologic measurements during Polysomnography (PSG) - Respiratory effort data

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

  During sleep study exam (PSG), approximately 8 hours

• Basic physiologic measurements during Polysomnography (PSG) - Video data

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

  During sleep study exam (PSG), approximately 8 hours

Secondary Outcomes (1)

• Amount of current needed for adequate stimulation

  Collected during operative and sleep study procedures, taking about 15 minutes.

Study Arms (1)

Muscle stimulation

EXPERIMENTAL

Consented participants who meet eligibility will have a drug induced sleep endoscopy (DISE) and second sleep study and the Grass S88 (or comparable) muscle stimulator.

Device: Grass S88 Muscle Stimulator

Interventions

Grass S88 Muscle Stimulator DEVICE

The Grass S88 nerve and muscle stimulator is a widely-used tool in electromyography and nerve conduction studies. During the DISE and second sleep study, fine-wire electrodes will be placed into the hypoglossal nerve or genioglossus muscle. Two more electrodes are placed transcutaneously, proximate to the bilateral branches of the cervicalis innervating the sternothyroid muscle in the anterior neck.

Muscle stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consenting adults with BMI≥ 25 and ≤ 40 kg/m2
• Obstructive sleep apnea with an AHI between 20 and 80 events/hr (with hypopneas defined by 4% oxyhemoglobin desaturations); ≥80% obstructive events.

You may not qualify if:

• Chronic use of opiate medications, illicit drug use, or alcohol dependency
• Other known concomitant sleep disorder (e.g., central sleep apnea, periodic limb movements, narcolepsy)
• Clinical history or evidence of cardiopulmonary disease (or oxygen use), liver, renal, immunodeficiency, neurodegenerative diseases, or previous adverse reactions to anesthesia.
• Prior upper airway reconstructive surgery excluding tonsillectomy (e.g., cleft palate repair, uvulopalatopharyngoplasty)
• Indwelling neurostimulation device (e.g. cardiac pacemaker, spinal, vagal, or hypoglossal nerve stimulator)

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• David T. Kent, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katie Hartley-Estes, RPSGT

CONTACT

615-875-9214; katherine.e.hartley@vumc.org

Nicole L Jones, MS

CONTACT

615-936-2807; nicole.l.jones@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Otolaryngology-Head and Neck Surgery

Model Details: All patients who meet eligibility will undergo the screening sleep study, muscle stimulation during operative DISE procedure, and muscle stimulation during second sleep study.

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 15, 2022
• Study Start: November 3, 2022
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)