NCT05661747

Dental Appliance to Treat SDB in Children

Use of Intraoral Device to Treat Snoring, Sleep Apnea, and Other Symptoms of Sleep-Disordered Breathing in Children

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Vivos BioTechnologies, Inc. · Industry
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Snoring
• Apnea, Obstructive
• Upper Airway Resistance Syndrome
• Sleep-Disordered Breathing

Interventions

Type	Name	Description
DEVICE	Vivos Grow/Vivos Way Device	Children already using the device will be monitored to determined whether it improves symptoms of SDB

Timeline

• Start date: 2022-05-03
• Primary completion: 2024-12-31
• Completion: 2025-03-31
• First posted: 2022-12-22
• Last updated: 2022-12-22

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study