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Clinical Trial Summary

The clinical hypothesis of this study is that a currently marketed mouthguard may also be able to reduce the symptoms of sleep-disordered breathing in children.


Clinical Trial Description

The purpose of this study is to evaluate the safety and efficacy of an mouthguard (Vivos Grow/Vivos Way) to reduce sleep-disordered breathing (SDB) in children, including: snoring, mild to moderate obstructive sleep apnea (OSA), and upper airway resistance syndrome (UARS) in children. The subjects enrolled in this study will be using the Vivos Grow/Vivos Way to correct orthodontic issues and must also present with signs of SDB. The study will recruit pediatric subjects who have already elected to utilize the study device for their orthodontic treatment; if they meet the inclusion and exclusion criteria they can be included in the study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05661747
Study type Interventional
Source Vivos BioTechnologies, Inc.
Contact Colette Cozean, Ph.D.
Phone 19498552885
Email colettecozean@gmail.com
Status Recruiting
Phase Phase 4
Start date May 3, 2022
Completion date March 31, 2025

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