Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05501236

Ansa Cervicalis and Hypoglossal Nerve Stimulation in OSA

Led by Vanderbilt University Medical Center · Updated on 2025-10-15

100

Participants Needed

1

Research Sites

212 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Ansa Cervicalis and Hypoglossal Nerve Stimulation in OSA

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Consenting adults with a body mass index (BMI) of 25 to 40 kg/m2
  • Diagnosed obstructive sleep apnea with an apnea-hypopnea index (AHI) between 20 and 80 events per hour
  • At least 80% of apnea events are obstructive in nature
Not Eligible

You will not qualify if you...

  • Chronic use of opiate medications, illicit drug use, or alcohol dependency
  • Presence of other known sleep disorders such as central sleep apnea, periodic limb movements, or narcolepsy
  • History or evidence of cardiopulmonary disease, liver, renal, immunodeficiency, neurodegenerative diseases, or adverse reactions to anesthesia
  • Prior upper airway reconstructive surgery excluding tonsillectomy
  • Having an implanted neurostimulation device such as a cardiac pacemaker or nerve stimulator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

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Research Team

K

Katie Hartley-Estes, RPSGT

CONTACT

N

Nicole L Jones, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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