Apnea, Obstructive, Sleep-Disordered Breathing, Snoring, Upper Airway Resistance Syndrome
Conditions
Brief 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.
Detailed description
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.
Interventions
DEVICEVivos Grow/Vivos Way Device
Children already using the device will be monitored to determined whether it improves symptoms of SDB
Sponsors
Vivos BioTechnologies, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
No masking is possible, as each child will serve as their own control in using the mouthguard, and their progress will be compared to their measurements prior to beginning the trial.
Intervention model description
The patient will serve as their own control.
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Sleep Questionnaire | An initial evaluation before treatment and upon completion of the study (an average of 1 year) | 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. |
| Sleep Study | An initial evaluation before treatment and upon completion of the study (an average of 1 year) | A home sleep study before and after treatment to assess any changes in sleep disturbance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Related Breathing Disordered Questionnaire (SRBD) | An initial evaluation before treatment and upon completion of the study (an average of 1 year) | 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. |
| Airway Volume | An initial evaluation before treatment and upon completion of the study (an average of 1 year) | Measured using a 3D cone beam scan, the change in airway volume will be assessed. |
Countries
United States
Contacts
Primary ContactColette Cozean, Ph.D.
Backup ContactMark Musso, DDS
Outcome results
None listed