Dental Appliance to Treat SDB in Children

Launched by VIVOS BIOTECHNOLOGIES, INC. · Dec 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying whether a special mouthguard, which is already available on the market, can help reduce symptoms of sleep-disordered breathing (SDB) in children. SDB includes issues like snoring and obstructive sleep apnea, which can affect a child’s sleep quality and overall health. The researchers want to see if this dental appliance can improve these conditions for kids who are also planning to get orthodontic treatment.

To participate in the trial, children must be between 6 and 18 years old and have a diagnosis of sleep-disordered breathing. They must also have permanent or mixed teeth. However, some children may not be eligible if they have poor oral hygiene, uncontrolled diabetes, severe sleep apnea, or certain other medical conditions. Those who join the study can expect to use the mouthguard and be monitored for any improvements in their sleep-related symptoms. This trial is currently recruiting participants across the United States, and parents will need to provide consent for their child to take part.

Gender

ALL

Eligibility criteria

• 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 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
• 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

Trial Officials