Dental Appliance to Treat SDB in Children

Last updated: December 14, 2022
Sponsor: Vivos BioTechnologies, Inc.
Overall Status: Active - Recruiting

Phase

4

Condition

Sleep Disorders

Sleep Apnea Syndromes

Treatment

N/A

Clinical Study ID

NCT05661747
VG-01
  • Ages 7-17
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Over the age of 6 and under the age of 18 years
  • Permanent dentition or mixed dentition at time of evaluation
  • Diagnosis of sleep-disordered breathing (including snoring, upper airway resistancesyndrome, and/or mild to moderate obstructive sleep apnea)
  • Have chosen to have orthodontic treatment
  • Living in the United States
  • Signed Informed Consent Form

Exclusion

Exclusion Criteria:

  • Poor oral hygiene
  • Uncontrolled diabetes
  • Severe obstructive sleep apnea (AHI> 10/hr)
  • Enlarged tonsils of a Grade 4 (>75% of space between pillars)
  • Diagnosed with a Temporomandibular join condition (TMJ)
  • Any severe breathing or respiratory disorder, such as chronic asthma, emphysema, COPD,or a similar condition
  • Orthodontic braces in situ

Study Design

Total Participants: 50
Study Start date:
May 03, 2022
Estimated Completion Date:
March 31, 2025

Study 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.

Connect with a study center

  • Breathing and Sleep Center

    Colorado Springs, Colorado 80918
    United States

    Active - Recruiting

  • Emerald Coast Dental Spa and Sleep Medicine

    Panama City Beach, Florida 32408
    United States

    Active - Recruiting

  • Musso Family Dentistry

    Garland, Texas 75401
    United States

    Site Not Available

  • New Teeth Dental Solutions

    League City, Texas 77573
    United States

    Active - Recruiting

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