RECRUITING

Dental Appliance to Treat SDB in Children

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-05-03
Study Completion:2025-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05661747

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.

Ages Eligible for Study:7 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Over the age of 6 and under the age of 18 years
  2. * Permanent dentition or mixed dentition at time of evaluation
  3. * Diagnosis of sleep-disordered breathing (including snoring, upper airway resistance syndrome, and/or mild to moderate obstructive sleep apnea)
  4. * Have chosen to have orthodontic treatment
  5. * Living in the United States
  6. * Signed Informed Consent Form
  1. * Poor oral hygiene
  2. * Uncontrolled diabetes
  3. * Severe obstructive sleep apnea (AHI\> 10/hr)
  4. * Enlarged tonsils of a Grade 4 (\>75% of space between pillars)
  5. * Diagnosed with a Temporomandibular join condition (TMJ)
  6. * Any severe breathing or respiratory disorder, such as chronic asthma, emphysema, COPD, or a similar condition
  7. * Orthodontic braces in situ

Contacts and Locations

Study Contact

Colette Cozean, Ph.D.
CONTACT
19498552885
colettecozean@gmail.com
Mark Musso, DDS
CONTACT
972-840-8477
drmusso@sbcglobal.net

Principal Investigator

Mark Musso, DDS
PRINCIPAL_INVESTIGATOR
Musso Family Dentistry

Study Locations (Sites)

Breathing and Sleep Center
Colorado Springs, Colorado, 80918
United States
Emerald Coast Dental Spa and Sleep Medicine
Panama City Beach, Florida, 32408
United States
Musso Family Dentistry
Garland, Texas, 75401
United States
New Teeth Dental Solutions
League City, Texas, 77573
United States

Collaborators and Investigators

Sponsor: Vivos BioTechnologies, Inc.

  • Mark Musso, DDS, PRINCIPAL_INVESTIGATOR, Musso Family Dentistry

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-03
Study Completion Date2025-03-31

Study Record Updates

Study Start Date2022-05-03
Study Completion Date2025-03-31

Terms related to this study

Additional Relevant MeSH Terms

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