Dental Appliance to Treat SDB in Children

Status unconfirmed · Phase 4

Conditions studied: Snoring, Apnea, Obstructive, Upper Airway Resistance Syndrome, Sleep-Disordered Breathing

In brief

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.

Key facts

Study ID

NCT05661747

Run by

Vivos BioTechnologies, Inc.

People needed

50

Starts

2022-05-03

Expected to finish

2025-03-31

Last updated by the study team

2022-12-22

Who can join

Age: 7 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Breathing and Sleep Center — Colorado Springs, Colorado, United States (enrolling)
• Emerald Coast Dental Spa and Sleep Medicine — Panama City Beach, Florida, United States (enrolling)
• New Teeth Dental Solutions — League City, Texas, United States (enrolling)
• Musso Family Dentistry — Garland, Texas, United States

Full record on ClinicalTrials.gov

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