Dental Appliance to Treat SDB in Children
Launched by VIVOS BIOTECHNOLOGIES, INC. · Dec 14, 2022
Trial Information
Current as of January 21, 2025
Recruiting
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
Mark Musso, DDS
Principal Investigator
Musso Family Dentistry
About Vivos Biotechnologies, Inc.
Vivos Biotechnologies, Inc. is a pioneering biotechnology company focused on developing innovative therapeutic solutions for a range of medical conditions. With a commitment to advancing patient care through cutting-edge research and technology, Vivos harnesses the power of biotechnology to create products that aim to improve health outcomes and enhance quality of life. The company is dedicated to conducting rigorous clinical trials that adhere to the highest standards of scientific integrity and regulatory compliance, ensuring that their therapies are both safe and effective. Through collaboration with leading experts and institutions, Vivos Biotechnologies strives to push the boundaries of medical science and deliver transformative treatments to patients in need.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Colorado Springs, Colorado, United States
Panama City Beach, Florida, United States
Garland, Texas, United States
League City, Texas, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
Similar Trials