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Clinical Trial Summary

Currently, there is no pharmacological intervention capable of maintaining airway patency for the treatment of snoring and airflow limitation during sleep. Here we study the effect of pharmacological stimulation of the pharyngeal muscles on snoring severity, in a randomized quadruple-blind, crossover study.


Clinical Trial Description

Two active interventions are being studied and compared against placebo. Participants will therefore be randomized to one of six possible sequences. Washout periods will be 1 week.

Effects of interventions on outcomes will be assessed using mixed effect model analyses: we will quantify the effect of active treatment 1 (referenced to placebo), the effect of active treatment 2 (referenced to placebo), adjusting for effects of time (period number), carryover effects, and baseline values (fixed effects). Participants are considered random effects.

Primary outcome is based on significance of active intervention 1 versus placebo. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03720353
Study type Interventional
Source Brigham and Women's Hospital
Contact
Status Completed
Phase Phase 1/Phase 2
Start date December 17, 2018
Completion date December 10, 2019

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