Use of Intraoral Device to Treat Snoring, Sleep Apnea, and Other Symptoms of Sleep-Disordered Breathing in Children
Status: Unknown
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 17
Healthy Volunteers: f
View:
• 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
Locations
United States
Colorado
Breathing and Sleep Center
RECRUITING
Colorado Springs
Florida
Emerald Coast Dental Spa and Sleep Medicine
RECRUITING
Panama City Beach
Texas
Musso Family Dentistry
NOT_YET_RECRUITING
Garland
New Teeth Dental Solutions
RECRUITING
League City
Contact Information
Primary
Colette Cozean, Ph.D.
colettecozean@gmail.com
19498552885
Backup
Mark Musso, DDS
drmusso@sbcglobal.net
972-840-8477
Time Frame
Start Date: 2022-05-03
Completion Date: 2025-03-31
Participants
Target number of participants: 50
Treatments
Experimental: Intervention Arm will use Vivos Grow/Vivos Way Device
This intervention will compare measurements prior to treatment with measurements post-treatment.
Related Therapeutic Areas
Sponsors
Leads: Vivos BioTechnologies, Inc.