Dental Appliance to Treat SDB in Children

Description

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

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Study Overview

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Study Details

Study overview

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.

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

Dental Appliance to Treat SDB in Children

Condition
Snoring
Intervention / Treatment

-

Contacts and Locations

Colorado Springs

Breathing and Sleep Center, Colorado Springs, Colorado, United States, 80918

Panama City Beach

Emerald Coast Dental Spa and Sleep Medicine, Panama City Beach, Florida, United States, 32408

Garland

Musso Family Dentistry, Garland, Texas, United States, 75401

League City

New Teeth Dental Solutions, League City, Texas, United States, 77573

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 resistance syndrome, and/or mild to moderate obstructive sleep apnea)
  • * Have chosen to have orthodontic treatment
  • * Living in the United States
  • * Signed Informed Consent Form
  • * 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

Ages Eligible for Study

7 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vivos BioTechnologies, Inc.,

Mark Musso, DDS, PRINCIPAL_INVESTIGATOR, Musso Family Dentistry

Study Record Dates

2025-03-31