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Dental Appliance to Treat SDB in Children

Sponsor
Vivos BioTechnologies, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05661747
Collaborator
(none)
50
Enrollment
4
Locations
1
Arm
34.9
Anticipated Duration (Months)
12.5
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Vivos Grow/Vivos Way Device
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
The patient will serve as their own control.The patient will serve as their own control.
Masking:
None (Open Label)
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.
Primary Purpose:
Treatment
Official Title:
Use of Intraoral Device to Treat Snoring, Sleep Apnea, and Other Symptoms of Sleep-Disordered Breathing in Children
Actual Study Start Date :
May 3, 2022
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Mar 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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 Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 17 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Breathing and Sleep Center Colorado Springs Colorado United States 80918
2 Emerald Coast Dental Spa and Sleep Medicine Panama City Beach Florida United States 32408
3 Musso Family Dentistry Garland Texas United States 75401
4 New Teeth Dental Solutions League City Texas United States 77573

Sponsors and Collaborators

  • Vivos BioTechnologies, Inc.

Investigators

  • Principal Investigator: Mark Musso, DDS, Musso Family Dentistry

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vivos BioTechnologies, Inc.
ClinicalTrials.gov Identifier:
NCT05661747
Other Study ID Numbers:
  • VG-01
First Posted:
Dec 22, 2022
Last Update Posted:
Dec 22, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Respiratory Aspiration
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Snoring

Study Results

No Results Posted as of Dec 22, 2022