Back to resultsDental Appliance to Treat SDB in Children
Primary Purpose
Snoring, Apnea, Obstructive, Upper Airway Resistance Syndrome
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vivos Grow/Vivos Way Device
Sponsored by
About this trial
This is an interventional treatment trial for Snoring
Eligibility Criteria
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
Sites / Locations
- Breathing and Sleep CenterRecruiting
- Emerald Coast Dental Spa and Sleep MedicineRecruiting
- Musso Family Dentistry
- New Teeth Dental SolutionsRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention Arm will use Vivos Grow/Vivos Way Device
Arm Description
This intervention will compare measurements prior to treatment with measurements post-treatment.
Outcomes
Primary Outcome Measures
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.
Sleep Study
A home sleep study before and after treatment to assess any changes in sleep disturbance.
Secondary Outcome Measures
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.
Airway Volume
Measured using a 3D cone beam scan, the change in airway volume will be assessed.
Full Information
NCT ID
NCT05661747
First Posted
December 14, 2022
Last Updated
December 14, 2022
Sponsor
Vivos BioTechnologies, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05661747
Brief Title
Dental Appliance to Treat SDB in Children
Official Title
Use of Intraoral Device to Treat Snoring, Sleep Apnea, and Other Symptoms of Sleep-Disordered Breathing in Children
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vivos BioTechnologies, Inc.
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Snoring, Apnea, Obstructive, Upper Airway Resistance Syndrome, Sleep-Disordered Breathing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
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.
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Arm will use Vivos Grow/Vivos Way Device
Arm Type
Experimental
Arm Description
This intervention will compare measurements prior to treatment with measurements post-treatment.
Intervention Type
Device
Intervention Name(s)
Vivos Grow/Vivos Way Device
Intervention Description
Children already using the device will be monitored to determined whether it improves symptoms of SDB
Primary Outcome Measure Information:
Title
Pediatric Sleep Questionnaire
Description
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.
Time Frame
An initial evaluation before treatment and upon completion of the study (an average of 1 year)
Title
Sleep Study
Description
A home sleep study before and after treatment to assess any changes in sleep disturbance.
Time Frame
An initial evaluation before treatment and upon completion of the study (an average of 1 year)
Secondary Outcome Measure Information:
Title
Sleep Related Breathing Disordered Questionnaire (SRBD)
Description
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.
Time Frame
An initial evaluation before treatment and upon completion of the study (an average of 1 year)
Title
Airway Volume
Description
Measured using a 3D cone beam scan, the change in airway volume will be assessed.
Time Frame
An initial evaluation before treatment and upon completion of the study (an average of 1 year)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Colette Cozean, Ph.D.
Phone
19498552885
Email
colettecozean@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Musso, DDS
Phone
972-840-8477
Email
drmusso@sbcglobal.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Musso, DDS
Organizational Affiliation
Musso Family Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Breathing and Sleep Center
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80918
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Goles, DDS
Phone
719-204-8201
Email
kevin@breathingandsleepcenter.com
Facility Name
Emerald Coast Dental Spa and Sleep Medicine
City
Panama City Beach
State/Province
Florida
ZIP/Postal Code
32408
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tara Griffen, DDS
Phone
972-840-8477
Email
taragriffenmd@gmail.com
Facility Name
Musso Family Dentistry
City
Garland
State/Province
Texas
ZIP/Postal Code
75401
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Musso, DDS
Phone
972-840-8477
Email
drmusso@sbcglobal.net
Facility Name
New Teeth Dental Solutions
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kalli Hale, DDS
Phone
281-554-9090
Email
kallihale@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Dental Appliance to Treat SDB in Children
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