Ignite Creation Date:
2024-05-06 @ 2:27 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04322097
Status:
RECRUITING
Last Update Posted:
2023-11-30
First Post:
2020-03-19
Brief Title:
Mechanisms of Upper Airway Obstruction
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Characterizing Mechanisms of Upper Airway Obstruction During Drug-Induced Sleep Endoscopy DISE
Status:
RECRUITING
Status Verified Date:
2023-11
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:
DISE-CAD
Brief Summary:
The current study is designed to examine underlying mechanisms of action of lingual muscles in the maintenance of airway patency during sleep The investigators major hypothesis is that specific tongue muscles are responsible for relieving upper airway obstruction during sleep
Detailed Description:
Obstructive sleep apnea OSA is characterized by recurrent upper airway obstruction due to inadequate muscle tone during sleep leading to nocturnal hypercapnia repeated oxyhemoglobin desaturations and arousals Continuous positive airway pressure CPAP is the therapeutic mainstay for OSA but adherence remains poor The loss of motor input to the tongue during sleep has been implicated as a cause for upper airway collapse Activation of tongue muscles with implanted hypoglossal nerve stimulators is an effective therapy for some OSA patients Nevertheless approximately 13 of OSA patients did not respond to hypoglossal nerve stimulation despite rigorous selection criteria leaving large segments of CPAP intolerant patients at risk for OSA-related morbidity Thus there is a critical knowledge gap in the role of lingual muscle activity in the maintenance of airway patency
The current study is designed to examine underlying mechanisms of action of lingual muscles in the maintenance of airway patency during sleep The investigators major hypothesis is that specific tongue muscles are responsible for relieving upper airway obstruction during sleep To address this hypothesis the investigators will 1 selectively stimulate specific lingual muscle groups viz protrudors and retractors and measure effects on airway patency during Drug Induced Sleep Endoscopy DISE The investigators will 2 correlate responses in patency to alterations in tongue morphology as assessed with ultrasound imaging The investigators will 3 examine the impact of anatomic factors eg the size of the maxillo-mandibular enclosure on airway responses to stimulation Patients will 4 undergo magnetic resonance imaging MRI determine the extent to which maxillo-mandibular size and tongue size and fat content compress pharyngeal structures The investigators will 5 assess apnea severity and hypoglossal nerve stimulation with Inspire to measure response to therapy via split-night PSGs The investigators will 6 examine digital morphometrics to quantify pharyngeal anatomy A final goal is to 7 measure tongue force as tongue force measurements may elucidate mechanisms of therapy response as related to neuromuscular control
The study will contain two distinct pathways Study A and Study B in order to efficiently execute the protocol Study A will focus primarily on measurements obtained as part of routine clinical care Study B will focus on enhanced imaging and physiology techniques in patients using lingual muscle stimulation Inspire
As of 6112021 the target recruitment for Study A was completed
Study A
To determine the contribution of defects in upper airway function to the pathogenesis of airway obstruction at specific sites of pharyngeal collapse by characterizing upper airway pressure-flowarea relationships during DISE
To determine the impact of jaw thrust and mouth closure maneuvers to functional determinants of upper airway obstruction at specific sites of pharyngeal collapse
To examine effects of maxillo-mandibular restriction and tongue size on upper airway functional properties during DISE
Study B In addition to the objectives for Study A
To assess effects of stimulating specific lingual muscles on upper airway patency during natural sleep and drug-induced sleep
To assess whether craniofacial morphology predicts improvements in pharyngeal patency during sleep with stimulation
The current study is designed to examine underlying mechanisms of action of lingual muscles in the maintenance of airway patency during sleep The investigators major hypothesis is that specific tongue muscles are responsible for relieving upper airway obstruction during sleep To address this hypothesis the investigators will 1 selectively stimulate specific lingual muscle groups viz protrudors and retractors and measure effects on airway patency during Drug Induced Sleep Endoscopy DISE The investigators will 2 correlate responses in patency to alterations in tongue morphology as assessed with ultrasound imaging The investigators will 3 examine the impact of anatomic factors eg the size of the maxillo-mandibular enclosure on airway responses to stimulation Patients will 4 undergo magnetic resonance imaging MRI determine the extent to which maxillo-mandibular size and tongue size and fat content compress pharyngeal structures The investigators will 5 assess apnea severity and hypoglossal nerve stimulation with Inspire to measure response to therapy via split-night PSGs The investigators will 6 examine digital morphometrics to quantify pharyngeal anatomy A final goal is to 7 measure tongue force as tongue force measurements may elucidate mechanisms of therapy response as related to neuromuscular control
The study will contain two distinct pathways Study A and Study B in order to efficiently execute the protocol Study A will focus primarily on measurements obtained as part of routine clinical care Study B will focus on enhanced imaging and physiology techniques in patients using lingual muscle stimulation Inspire
As of 6112021 the target recruitment for Study A was completed
Study A
To determine the contribution of defects in upper airway function to the pathogenesis of airway obstruction at specific sites of pharyngeal collapse by characterizing upper airway pressure-flowarea relationships during DISE
To determine the impact of jaw thrust and mouth closure maneuvers to functional determinants of upper airway obstruction at specific sites of pharyngeal collapse
To examine effects of maxillo-mandibular restriction and tongue size on upper airway functional properties during DISE
Study B In addition to the objectives for Study A
To assess effects of stimulating specific lingual muscles on upper airway patency during natural sleep and drug-induced sleep
To assess whether craniofacial morphology predicts improvements in pharyngeal patency during sleep with stimulation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None