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Ansa Cervicalis and Hypoglossal Nerve Stimulation in OSA

NCT05501236 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-10-15

No results posted yet for this study

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

Interventions

DEVICE

Grass S88 Muscle Stimulator

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.

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-03
Primary Completion
2026-05-30
Completion
2026-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05501236 on ClinicalTrials.gov