Ignite Creation Date:
2024-05-06 @ 6:00 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05501236
Status:
RECRUITING
Last Update Posted:
2023-12-19
First Post:
2022-07-28
Brief Title:
Ansa Cervicalis and Hypoglossal Nerve Stimulation in OSA
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Ansa Cervicalis and Hypoglossal Nerve Stimulation in Obstructive Sleep Apnea
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 muscles on upper airway pressure-area and pressure-flow relationships and 2 determine how subject anatomic physiologic and polysomnographic characteristics modulate these responses
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 muscles on upper airway pressure-area and pressure-flow relationships and 2 determine how subject anatomic physiologic and polysomnographic characteristics modulate these responses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None