Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
50

Summary

Conditions
Obstructive Sleep Apnea
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Basic Science

Participation Requirements

Age
Between 22 years and 125 years
Gender
Both males and females

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 adh...

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 1/3 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 also (2) correlate responses in patency to alterations in tongue morphology (as assessed with ultrasound imaging). A final goal is to (3) examine the impact of anatomic factors (e.g., the size of the maxillo-mandibular enclosure) on airway responses to stimulation. Objectives (all primary and secondary objectives) To assess effects of stimulating specific lingual muscles on upper airway patency during DISE and on tongue morphology. The investigators hypothesize that stimulation will lead to improvements in upper airway patency during DISE when tongue protrudors are stimulated, and that concomitant stimulation of retractors will augment this response. To correlate improvements in upper airway patency during sleep with stimulation to alterations in tongue shape and position when stimulating during DISE. The investigators hypothesize that the restoration of airway patency during sleep will be associated with anterior tongue movement and preservation of tongue shape when stimulated during DISE. To assess whether craniofacial morphology predicts improvements in pharyngeal patency during DISE with stimulation. The investigators hypothesize that maxillo-mandibular restriction will be associated with diminished responses in airway patency to stimulation during DISE.

Tracking Information

NCT #
NCT04322097
Collaborators
Not Provided
Investigators
Principal Investigator: Raj C Dedhia, MD University of Pennsylvania