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.
The purpose of this study is to evaluate the safety and efficacy of an mouthguard (Vivos Grow/Vivos Way) to reduce sleep-disordered breathing (SDB) in children, including: snoring, mild to moderate obstructive sleep apnea (OSA), and upper airway resistance syndrome (UARS) in children. The subjects enrolled in this study will be using the Vivos Grow/Vivos Way to correct orthodontic issues and must also present with signs of SDB. The study will recruit pediatric subjects who have already elected to utilize the study device for their orthodontic treatment; if they meet the inclusion and exclusion criteria they can be included in the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Children already using the device will be monitored to determined whether it improves symptoms of SDB
Breathing and Sleep Center
Colorado Springs, Colorado, United States
RECRUITINGEmerald Coast Dental Spa and Sleep Medicine
Panama City Beach, Florida, United States
RECRUITINGMusso Family Dentistry
Garland, Texas, United States
NOT_YET_RECRUITINGPediatric Sleep Questionnaire
Validated questionnaire for determining sleep-related breathing disorders, snoring, and behavior in childrne. The change in score on the PSQ will be assessed. It is scored from 0-1 with higher scores indicating increased symptoms of sleep disturbance and sleep-disordered breathing. Each question is tallied and an average of all answers (from 3 different subsections) gives the final score.
Time frame: An initial evaluation before treatment and upon completion of the study (an average of 1 year)
Sleep Study
A home sleep study before and after treatment to assess any changes in sleep disturbance.
Time frame: An initial evaluation before treatment and upon completion of the study (an average of 1 year)
Sleep Related Breathing Disordered Questionnaire (SRBD)
A validated subsection of the PSQ, the change in SRBD score will be assessed. It is a 22-questions subset of the PSQ, also graded from 0-1 with scores rising as symptoms of SDB increase.
Time frame: An initial evaluation before treatment and upon completion of the study (an average of 1 year)
Airway Volume
Measured using a 3D cone beam scan, the change in airway volume will be assessed.
Time frame: An initial evaluation before treatment and upon completion of the study (an average of 1 year)
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New Teeth Dental Solutions
League City, Texas, United States
RECRUITING