Dental Appliance to Treat SDB in Children

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

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.

Study Overview

• Status: Recruiting
• Conditions: Snoring; Sleep-Disordered Breathing; Apnea, Obstructive; Upper Airway Resistance Syndrome
• Intervention / Treatment: Device: Vivos Grow/Vivos Way Device

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Colette Cozean, Ph.D.; Phone Number: 19498552885; Email: colettecozean@gmail.com
• Study Contact Backup: Name: Mark Musso, DDS; Phone Number: 972-840-8477; Email: drmusso@sbcglobal.net

Study Locations

• United States
  • Colorado
    • Colorado Springs, Colorado, United States, 80918
      • Recruiting
      • Breathing and Sleep Center
      • Contact: Kevin Goles, DDS; Phone Number: 719-204-8201; Email: kevin@breathingandsleepcenter.com
  • Florida
    • Panama City Beach, Florida, United States, 32408
      • Recruiting
      • Emerald Coast Dental Spa and Sleep Medicine
      • Contact: Tara Griffen, DDS; Phone Number: 972-840-8477; Email: taragriffenmd@gmail.com
  • Texas
    • Garland, Texas, United States, 75401
      • Not yet recruiting
      • Musso Family Dentistry
      • Contact: Mark Musso, DDS; Phone Number: 972-840-8477; Email: drmusso@sbcglobal.net
    • League City, Texas, United States, 77573
      • Recruiting
      • New Teeth Dental Solutions
      • Contact: Kalli Hale, DDS; Phone Number: 281-554-9090; Email: kallihale@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Vivos BioTechnologies, Inc.
• Investigators: Principal Investigator: Mark Musso, DDS, Musso Family Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): March 31, 2025

Study Registration Dates

• First Submitted: December 14, 2022
• First Submitted That Met QC Criteria: December 14, 2022
• First Posted (Estimate): December 22, 2022

Study Record Updates

• Last Update Posted (Estimate): December 22, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Respiratory Sounds; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Respiratory Aspiration; Snoring
• Other Study ID Numbers: VG-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No