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Ansa Cervicalis and Hypoglossal Nerve Stimulation in OSA

Primary Purpose

Obstructive Sleep Apnea

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Grass S88 Muscle Stimulator
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Vanderbilt University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Muscle stimulation

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
Basic physiologic measurements during Polysomnography (PSG) - Airflow data
Airflow data (L/min) will be measured during the sleep study via a pneumotachometer applied to the nose.
Basic physiologic measurements during Polysomnography (PSG) - Electroencephalogram (EEG)
EEG (mV) will be collected during the sleep study via skin surface electrodes.
Basic physiologic measurements during Polysomnography (PSG) - Electrocardiogram (EKG)
EKG (mV) will be collected during the sleep study via skin surface electrodes.
Basic physiologic measurements during Polysomnography (PSG) - Electroocoulogram (EOG)
EOG (mV) will be collected during the sleep study via skin surface electrodes.
Basic physiologic measurements during Polysomnography (PSG) - Electromyography (EMG)
EMG data (mV) will be collected during the sleep study via skin surface electrodes.
Basic physiologic measurements during Polysomnography (PSG) - Respiratory effort data
Respiratory effort data (mV) will be collected during the sleep study via respiratory inductance plethysmography.
Basic physiologic measurements during Polysomnography (PSG) - Video data
Video data will be collected during the sleep study via in-room camera.

Secondary Outcome Measures

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.

Full Information

First Posted
July 28, 2022
Last Updated
August 21, 2023
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05501236
Brief Title
Ansa Cervicalis and Hypoglossal Nerve Stimulation in OSA
Official Title
Ansa Cervicalis and Hypoglossal Nerve Stimulation in Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 3, 2022 (Actual)
Primary Completion Date
May 30, 2026 (Anticipated)
Study Completion Date
November 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Muscle stimulation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Grass S88 Muscle Stimulator
Intervention Description
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 Measure Information:
Title
Basic physiologic measurements during Drug Induced Sleep Endoscopy (DISE) - Airway cross sectional diameter
Description
Airway cross-sectional diameter (mm^2) will be measured throughout the operative procedure via flexible fiberoptic nasopharyngoscopy.
Time Frame
During DISE, approximately 15 minutes
Title
Basic physiologic measurements during Drug Induced Sleep Endoscopy (DISE) - Airflow data
Description
Airflow data (L/min) will be measured throughout the operative procedure via a pneumotachometer applied to the nose.
Time Frame
During DISE, approximately 15 minutes
Title
Basic physiologic measurements during Drug Induced Sleep Endoscopy (DISE) - Upper airway pressure changes
Description
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 minutes
Title
Basic physiologic measurements during Drug Induced Sleep Endoscopy (DISE) - Respiratory effort data
Description
Respiratory effort data (mV) will be measured throughout the operative procedure via two respiratory inductance plethysmography belts.
Time Frame
During DISE, approximately 15 minutes
Title
Basic physiologic measurements during Polysomnography (PSG) - Airflow data
Description
Airflow data (L/min) will be measured during the sleep study via a pneumotachometer applied to the nose.
Time Frame
During sleep study exam (PSG), approximately 8 hours
Title
Basic physiologic measurements during Polysomnography (PSG) - Electroencephalogram (EEG)
Description
EEG (mV) will be collected during the sleep study via skin surface electrodes.
Time Frame
During sleep study exam (PSG), approximately 8 hours
Title
Basic physiologic measurements during Polysomnography (PSG) - Electrocardiogram (EKG)
Description
EKG (mV) will be collected during the sleep study via skin surface electrodes.
Time Frame
During sleep study exam (PSG), approximately 8 hours
Title
Basic physiologic measurements during Polysomnography (PSG) - Electroocoulogram (EOG)
Description
EOG (mV) will be collected during the sleep study via skin surface electrodes.
Time Frame
During sleep study exam (PSG), approximately 8 hours
Title
Basic physiologic measurements during Polysomnography (PSG) - Electromyography (EMG)
Description
EMG data (mV) will be collected during the sleep study via skin surface electrodes.
Time Frame
During sleep study exam (PSG), approximately 8 hours
Title
Basic physiologic measurements during Polysomnography (PSG) - Respiratory effort data
Description
Respiratory effort data (mV) will be collected during the sleep study via respiratory inductance plethysmography.
Time Frame
During sleep study exam (PSG), approximately 8 hours
Title
Basic physiologic measurements during Polysomnography (PSG) - Video data
Description
Video data will be collected during the sleep study via in-room camera.
Time Frame
During sleep study exam (PSG), approximately 8 hours
Secondary Outcome Measure Information:
Title
Amount of current needed for adequate stimulation
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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) Indwelling neurostimulation device (e.g. cardiac pacemaker, spinal, vagal, or hypoglossal nerve stimulator)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katie Hartley-Estes, RPSGT
Phone
615-875-9214
Email
katherine.e.hartley@vumc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Kate Von Wahlde, MJ, CCRP
Phone
615-322-0333
Email
kate.vonwahlde@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David T. Kent, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Estes-Hartley, RPSGT
Phone
615-875-9214
Email
katherine.e.hartley@vumc.org
First Name & Middle Initial & Last Name & Degree
Kate Von Wahlde, MJ,CCRP
Phone
615-322-0333
Email
kate.vonwahlde@vumc.org
First Name & Middle Initial & Last Name & Degree
David T Kent, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We do not plan to share IPD with other researchers.

Learn more about this trial

Ansa Cervicalis and Hypoglossal Nerve Stimulation in OSA

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