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Ansa Cervicalis and Hypoglossal Nerve Stimulation in OSA

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ClinicalTrials.gov Identifier: NCT05501236
Recruitment Status : Recruiting
First Posted : August 15, 2022
Last Update Posted : November 10, 2022
Sponsor:
Information provided by (Responsible Party):
David Kent, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: Grass S88 Muscle Stimulator Not Applicable

Detailed Description:

Obstructive Sleep Apnea (OSA) is a common disorder characterized by repetitive upper airway collapse during inspiration caused, in part, by a loss of neuromotor tone in specific upper airway muscles, with multiple associated health sequelae impacting millions of Americans. Patient adherence to the reference treatment, positive airway pressure (PAP), remains problematic. Despite the recent promising development of hypoglossal nerve stimulation (HNS) as a surgical therapy, its indications are limited and a proportion of eligible patients do not achieve sufficient response, leaving a critical unmet need for effective therapeutic alternatives to PAP.

This project challenges the long-held concept that the genioglossus muscle is primarily responsible for the maintenance of pharyngeal patency during sleep and proposes a novel therapeutic mechanism. It is built upon strong evidence that caudal pharyngeal traction from the trachea has a marked impact on pharyngeal patency primarily mediated through changes in lung volume. Contraction of the sternothyroid muscle, an infrahyoid cervical strap muscle that inserts onto the thyroid cartilage, also generates caudal pharyngeal traction. Our data suggest that ansa cervicalis stimulation (ACS) of the sternothyroid muscle unfolds and stretches the lateral pharyngeal walls and tensions the distal edge of the soft palate caudally, increasing airway patency.

The major hypothesis of the Investigators is that ACS overcomes specific anatomic and neuromuscular defects of upper airway control that restore pharyngeal patency in patients with OSA. This hypothesis is supported by published and preliminary data demonstrating that: (1) the degree of end-expiratory lung volume decrease in sleep correlates with observed increases in pharyngeal collapsibility, and (2) unilateral ACS increases maximum inspiratory airflow and velopharyngeal cross-sectional area during flow-limited breathing in sedated humans. These findings suggest that (3) tracheal traction, as mediated by end-expiratory lung volume (EELV), is a major contributor to airway patency in sleep. In this project, the Investigators will elucidate specific mechanisms for control of pharyngeal patency with caudal traction during drug-induced sleep endoscopy (DISE) and natural sleep (PSG). The Investigators will address these aims by characterizing (1) the effects of ACS of the sternothyroid muscle(s) on upper airway pressure-area and pressure-flow relationships, and (2) determine how subject anatomic, physiologic, and polysomnographic characteristics modulate these responses.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All patients who meet eligibility will undergo the screening sleep study, muscle stimulation during operative DISE procedure, and muscle stimulation during second sleep study.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Ansa Cervicalis and Hypoglossal Nerve Stimulation in Obstructive Sleep Apnea
Actual Study Start Date : November 4, 2022
Estimated Primary Completion Date : December 2027
Estimated Study Completion Date : July 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: Muscle stimulation
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
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.




Primary Outcome Measures :
  1. Basic physiologic measurements during Drug Induced Sleep Endoscopy (DISE) - Airway cross sectional diameter [ Time Frame: During DISE, approximately 15 minutes ]
    Airway cross-sectional diameter (mm^2) will be measured throughout the operative procedure via flexible fiberoptic nasopharyngoscopy.

  2. Basic physiologic measurements during Drug Induced Sleep Endoscopy (DISE) - Airflow data [ Time Frame: During DISE, approximately 15 minutes ]
    Airflow data (L/min) will be measured throughout the operative procedure via a pneumotachometer applied to the nose.

  3. Basic physiologic measurements during Drug Induced Sleep Endoscopy (DISE) - Upper airway pressure changes [ Time Frame: During DISE, approximately 15 minutes ]
    Upper airway pressure changes (cmH20) will be measured throughout the operative procedure via a pneumotachometer applied to the nose.

  4. Basic physiologic measurements during Drug Induced Sleep Endoscopy (DISE) - Respiratory effort data [ Time Frame: During DISE, approximately 15 minutes ]
    Respiratory effort data (mV) will be measured throughout the operative procedure via two respiratory inductance plethysmography belts.

  5. Basic physiologic measurements during Polysomnography (PSG) - Airflow data [ Time Frame: During sleep study exam (PSG), approximately 8 hours ]
    Airflow data (L/min) will be measured during the sleep study via a pneumotachometer applied to the nose.

  6. Basic physiologic measurements during Polysomnography (PSG) - Electroencephalogram (EEG) [ Time Frame: During sleep study exam (PSG), approximately 8 hours ]
    EEG (mV) will be collected during the sleep study via skin surface electrodes.

  7. Basic physiologic measurements during Polysomnography (PSG) - Electrocardiogram (EKG) [ Time Frame: During sleep study exam (PSG), approximately 8 hours ]
    EKG (mV) will be collected during the sleep study via skin surface electrodes.

  8. Basic physiologic measurements during Polysomnography (PSG) - Electroocoulogram (EOG) [ Time Frame: During sleep study exam (PSG), approximately 8 hours ]
    EOG (mV) will be collected during the sleep study via skin surface electrodes.

  9. Basic physiologic measurements during Polysomnography (PSG) - Electromyography (EMG) [ Time Frame: During sleep study exam (PSG), approximately 8 hours ]
    EMG data (mV) will be collected during the sleep study via skin surface electrodes.

  10. Basic physiologic measurements during Polysomnography (PSG) - Respiratory effort data [ Time Frame: During sleep study exam (PSG), approximately 8 hours ]
    Respiratory effort data (mV) will be collected during the sleep study via respiratory inductance plethysmography.

  11. Basic physiologic measurements during Polysomnography (PSG) - Video data [ Time Frame: During sleep study exam (PSG), approximately 8 hours ]
    Video data will be collected during the sleep study via in-room camera.


Secondary Outcome Measures :
  1. Amount of current needed for adequate stimulation [ Time Frame: Collected during operative and sleep study procedures, taking about 15 minutes. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05501236


Contacts
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Contact: Katie Hartley- Estes, RPSGT 615-875-9214 katherine.e.hartley@vumc.org
Contact: Kate Von Wahlde, MJ, CCRP 615-322-0333 kate.vonwahlde@vumc.org

Locations
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United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Katie Estes-Hartley, RPSGT    615-875-9214    katherine.e.hartley@vumc.org   
Contact: Kate Von Wahlde, MJ,CCRP    615-322-0333    kate.vonwahlde@vumc.org   
Principal Investigator: David T Kent, MD         
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: David T. Kent, MD Vanderbilt University Medical Center
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Responsible Party: David Kent, Assistant Professor, Department of Otolaryngology-Head and Neck Surgery, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT05501236    
Other Study ID Numbers: 212305
First Posted: August 15, 2022    Key Record Dates
Last Update Posted: November 10, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan to share IPD with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases