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Dental Appliance to Treat SDB in Children

NCT05661747 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-12-22

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Vivos Grow/Vivos Way Device

Children already using the device will be monitored to determined whether it improves symptoms of SDB

Sponsors & Collaborators

  • Vivos BioTechnologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Musso, DDS · Musso Family Dentistry

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-03
Primary Completion
2024-12-31
Completion
2025-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05661747 on ClinicalTrials.gov