Actively Recruiting
Ansa Cervicalis and Hypoglossal Nerve Stimulation in Obstructive Sleep Apnea
Led by Vanderbilt University Medical Center · Updated on 2025-10-15
100
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Obstructive sleep apnea (OSA) is a common condition involving repeated upper airway collapse during sleep, partly caused by weakened muscle control. This trial explores the effects of stimulating the ansa cervicalis nerve, which controls the sternothyroid muscle, alone and combined with hypoglossal nerve stimulation (HNS), to improve airway openness. The study aims to better understand how these stimulations affect airway function during sleep using drug-induced sleep endoscopy (DISE) and polysomnography (PSG). This research addresses the need for alternative treatments to positive airway pressure (PAP), which many patients struggle to use. Participants will undergo muscle stimulation using the Grass S88 device. During DISE, fine-wire electrodes will be placed near the hypoglossal nerve or genioglossus muscle, and additional electrodes near the cervicalis nerve branches controlling the sternothyroid muscle. Muscle stimulation effects will be studied during a DISE procedure lasting about 15 minutes and a second sleep study (PSG) lasting approximately 8 hours. These sessions will assess the impact of stimulation on airway anatomy and airflow. During the study, participants will be monitored with various physiological measurements including airway diameter, airflow, upper airway pressure, respiratory effort, EEG, EKG, EOG, EMG, and video data collected during DISE and PSG. Researchers will measure the required current for adequate stimulation during these procedures. The trial will track how stimulation influences airway function and sleep characteristics over these study periods, helping to define potential new therapeutic approaches for OSA.
CONDITIONS
Brief Title
Ansa Cervicalis and Hypoglossal Nerve Stimulation in OSA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Consenting adults with BMI ≥ 25 and ≤ 40 kg/m2
- Obstructive sleep apnea with an apnea-hypopnea index (AHI) between 20 and 80 events per hour, with at least 80% obstructive events
You will not qualify if you...
- Chronic use of opiate medications, illicit drug use, or alcohol dependency
- Other known sleep disorders such as central sleep apnea, periodic limb movements, or narcolepsy
- History or evidence of cardiopulmonary disease, liver, kidney, immune deficiency, neurodegenerative diseases, or previous adverse reactions to anesthesia
- Prior upper airway reconstructive surgery excluding tonsillectomy
- Presence of indwelling neurostimulation devices such as cardiac pacemaker, spinal, vagal, or hypoglossal nerve stimulators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo drug-induced sleep endoscopy (DISE) and a second sleep study with muscle stimulation to assess airway physiology.
1 visit (in-person)
Duration - Approximately 8 hours
Participants are monitored during the polysomnography (PSG) sleep study to collect physiologic measurements overnight.
1 overnight visit (in-person)
Trial Site Locations
Total: 1 location
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
K
Katie Hartley-Estes, RPSGT
N
Nicole L Jones, MS
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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