Dental Appliance to Treat SDB in Children
- Conditions
- Upper Airway Resistance SyndromeSnoringApnea, ObstructiveSleep-Disordered Breathing
- Interventions
- Device: Vivos Grow/Vivos Way Device
- Registration Number
- NCT05661747
- Lead Sponsor
- Vivos BioTechnologies, Inc.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention Arm will use Vivos Grow/Vivos Way Device Vivos Grow/Vivos Way Device This intervention will compare measurements prior to treatment with measurements post-treatment.
- Primary Outcome Measures
Name Time Method 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.
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.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (4)
Breathing and Sleep Center
🇺🇸Colorado Springs, Colorado, United States
Emerald Coast Dental Spa and Sleep Medicine
🇺🇸Panama City Beach, Florida, United States
Musso Family Dentistry
🇺🇸Garland, Texas, United States
New Teeth Dental Solutions
🇺🇸League City, Texas, United States