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Recruiting
NCT05661747
Dental Appliance to Treat SDB in Children
Conditions: Snoring, Apnea, Obstructive, Upper Airway Resistance Syndrome, Sleep-Disordered Breathing
Sex: All
Ages: 7 Years – 17 Years
Phase: PHASE4
Enrollment: 50
Sponsor: Vivos BioTechnologies, Inc.
Location: United States
Summary
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.
Eligibility Criteria
Inclusion Criteria:Over the age of 6 and under the age of 18 yearsPermanent dentition or mixed dentition at time of evaluationDiagnosis of sleep-disordered breathing (including snoring, upper airway resistance syndrome, and/or mild to moderate obstructive sleep apnea)Have chosen to have orthodontic treatmentLiving in the United StatesSigned Informed Consent FormExclusion Criteria:Poor oral hygieneUncontrolled diabetesSevere 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 conditionOrthodontic braces in situ
Source: ClinicalTrials.gov (NCT05661747). StuddyBuddy aggregates publicly available trial information.
