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Clinical Trial Summary

Currently, there is no pharmacological intervention for OSA that targets multiple pathophysiological deficits in combination. Here the investigators study the effect on sleep apnea severity of combinations of pharmacological agents that stimulate the pharyngeal muscles, stabilize ventilatory control, and increase the arousal threshold.


Clinical Trial Description

The primary goal of the current study is to determine the effect of combination therapy targeting phenotypic traits on OSA severity. Specifically, the investigators will assess the effect of combination pharmacological therapy on OSA severity as measured by the apnea-hypopnea index and the arousal index (co-primary outcome variables). The investigators will also estimate the effects of the interventions on the physiological traits responsible for OSA using polysomnography, namely: - Pharyngeal anatomy and its propensity towards collapse - The ability of the upper airway dilator muscles to activate and reopen the airway during sleep (i.e. neuromuscular compensation) - Arousal threshold from sleep (i.e. the propensity for hypopneas/apneas to lead to arousal and fragmented sleep). - Stability of the ventilatory control system feedback loop (i.e. loop gain). Baseline traits will be used to examine whether patient characteristics influence the responses to each combination of interventions (i.e. muscles, muscles plus loop gain, muscles plus arousal threshold). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03892772
Study type Interventional
Source Brigham and Women's Hospital
Contact
Status Completed
Phase Phase 1/Phase 2
Start date January 14, 2019
Completion date July 3, 2021

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