Dental Appliance to Treat SDB in Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Use of Intraoral Device to Treat Snoring, Sleep Apnea, and Other Symptoms of Sleep-Disordered Breathing in Children

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

Intervention / Treatment
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* Device: Vivos Grow/Vivos Way Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The patient will serve as their own control.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm will use Vivos Grow/Vivos Way Device<br>This intervention will compare measurements prior to treatment with measurements post-treatment. | Device: Vivos Grow/Vivos Way Device<br>* Children already using the device will be monitored to determined whether it improves symptoms of SDB<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pediatric 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. | 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. | An initial evaluation before treatment and upon completion of the study (an average of 1 year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | An initial evaluation before treatment and upon completion of the study (an average of 1 year) |