Ansa Cervicalis and Hypoglossal Nerve Stimulation in OSA
ConditionObstructive Sleep Apnea
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Grass S88 Muscle Stimulator
DeviceThe 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Muscle stimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
During DISE, approximately 15 minutes2
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.
Time frame
During DISE, approximately 15 minutes3
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.
Time frame
During DISE, approximately 15 minutes4
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.
Time frame
During DISE, approximately 15 minutesSecondary outcomes
1
Amount of current needed for adequate stimulation
Obtain preliminary data regarding including the amount of current needed to adequately stimulate the ansa cervicalis stimulation (ACS) alone and in combination with hypoglossal nerve stimulation (HNS) during PSG and DISE via a neurostimulator connected to percutaneous electrodes.
Time frame
Collected during operative and sleep study procedures, taking about 15 minutes.Sponsors and contacts
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Source ClinicalTrials.gov