Dental Appliance to Treat SDB in Children

Snoring Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05661747
• Other study ID #: VG-01
• Status: Recruiting
• Phase: Phase 4
• Start date: May 3, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: December 2022
• Source: Vivos BioTechnologies, Inc.
• Contact: Colette Cozean, Ph.D.
• Phone: 19498552885
• Email: colettecozean[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea, Obstructive
• Respiratory Aspiration
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep-Disordered Breathing
• Snoring
• Upper Airway Resistance Syndrome

Intervention

Device:
• Vivos Grow/Vivos Way Device
Children already using the device will be monitored to determined whether it improves symptoms of SDB

Locations

Country	Name	City	State
United States	Breathing and Sleep Center	Colorado Springs	Colorado
United States	Musso Family Dentistry	Garland	Texas
United States	New Teeth Dental Solutions	League City	Texas
United States	Emerald Coast Dental Spa and Sleep Medicine	Panama City Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Vivos BioTechnologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)