Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
30

Summary

Conditions
Obstructive Sleep Apnea
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: Single (Participant)Primary Purpose: Treatment

Participation Requirements

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

Description

Collapse of the upper airway can occur at different sites of the pharynx. One common and recognizable form of pharyngeal collapse is prolapse of the soft palate (velopharynx) on expiration, a phenomenon referred to as expiratory flow limitation (EFL). In principle, application of nasal positive expi...

Collapse of the upper airway can occur at different sites of the pharynx. One common and recognizable form of pharyngeal collapse is prolapse of the soft palate (velopharynx) on expiration, a phenomenon referred to as expiratory flow limitation (EFL). In principle, application of nasal positive expiratory pressure should reverse expiratory narrowing, increase ventilation, and prevent the subsequent progressive loss of airflow that leads to arousal from sleep, thereby improving OSA. One means to achieve this expiratory pressure is with the use of an added nasal expiratory resistance. Accordingly, during a single night protocol, the investigators will examine the effects of increasing nasal expiratory resistance during sleep. During obstructed breathing, patients will be switched acutely, in random order, from normal conditions to an added expiratory resistance (30-80 cmH2O/L.s) or a sham resistance, for short (1 min) and prolonged periods (1 hour), repeatedly overnight. Patients participating in the study will be divided into two groups, those exhibiting EFL versus those without EFL (i.e. with inspiratory flow limitation). The main outcomes of the short physiologic interventions are: Increase in ventilation, and Increased time to a respiratory-related arousal from sleep, relative to sham conditions. The main outcome of the prolonged interventions is: --Reduced frequency of respiratory events (AHI; 3% desaturation or arousal) relative to sham conditions. The central objective of the study is to test whether there is a greater improvement in the above outcomes in those with EFL versus those without EFL. This data will allow us to test whether expiratory resistance is of potential therapeutic benefit specifically in patients with EFL rather than those without EFL.

Tracking Information

NCT #
NCT02612038
Collaborators
Not Provided
Investigators
Principal Investigator: Andrew Wellman, PhD MD Brigham and Women's Hospital