Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Sleep Apnea - Obstructive
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: None (Open Label)Primary Purpose: Basic Science

Participation Requirements

Age
Between 21 years and 70 years
Gender
Both males and females

Description

OSA patients will undergo a baseline sleep endoscopy study to identify the site of pharyngeal collapse. Subsequently, they will undergo two clinical polysomnographies (PSGs) to measure the effect of an oral appliance (a site specific therapy) on upper airway collapsibility and sleep apnea severity. ...

OSA patients will undergo a baseline sleep endoscopy study to identify the site of pharyngeal collapse. Subsequently, they will undergo two clinical polysomnographies (PSGs) to measure the effect of an oral appliance (a site specific therapy) on upper airway collapsibility and sleep apnea severity. During the first hour of each clinical PSG, the passive pharyngeal collapsibility will be determined using the standard 5-breath continuous positive airway pressure (CPAP) drop method. During the remainder of the night, patients will be monitored to determine sleep apnea severity (apnea-hypopnea index). These measurements will allow the investigators to determine which pharyngeal collapsing site responds best (both in terms of collapsibility and AHI) to mandibular advancement with an oral appliance. Patients who have their own oral appliance will be recruited. In addition, patients without an oral appliance will be provided with a temporary oral appliance for the study.

Tracking Information

NCT #
NCT02489591
Collaborators
Not Provided
Investigators
Principal Investigator: David A Wellman, PhD Brigham and Women's Hospital