Recruiting

Dental Appliance

Sponsor:

Vivos BioTechnologies, Inc.

Code:

NCT05661747

Conditions

Snoring

Apnea, Obstructive

Upper Airway Resistance Syndrome

Sleep-Disordered Breathing

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

Interventions

Vivos Grow/Vivos Way Device

Study Details

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.

Conditions

Snoring

Apnea, Obstructive

Upper Airway Resistance Syndrome

Sleep-Disordered Breathing

Study ID

NCT05661747

Start date

May 3, 2022

Status verified date

Dec, 2022

Completion date

Mar 31, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention Arm will use Vivos Grow/Vivos Way Device

This intervention will compare measurements prior to treatment with measurements post-treatment.

Interventions

Vivos Grow/Vivos Way Device

Children already using the device will be monitored to determined whether it improves symptoms of SDB

Primary outcome measure

  • Pediatric Sleep Questionnaire [ Time Frame: An initial evaluation before treatment and upon completion of the study (an average of 1 year) ]
  • Sleep Study [ Time Frame: An initial evaluation before treatment and upon completion of the study (an average of 1 year) ]

Central Contacts and Locations

Central contacts

Colette Cozean, Ph.D.

19498552885colettecozean@gmail.com

Mark Musso, DDS

972-840-8477drmusso@sbcglobal.net

Locations

Breathing and Sleep Center

Recruiting

Colorado Springs, Colorado, United States, 80918

Contacts

Kevin Goles, DDS

719-204-8201kevin@breathingandsleepcenter.com

Emerald Coast Dental Spa and Sleep Medicine

Recruiting

Panama City Beach, Florida, United States, 32408

Contacts

Tara Griffen, DDS

972-840-8477taragriffenmd@gmail.com

New Teeth Dental Solutions

Recruiting

League City, Texas, United States, 77573

Contacts

Kalli Hale, DDS

281-554-9090kallihale@gmail.com

More Information

Sponsor

Vivos BioTechnologies, Inc.

Last update posted

Dec 22, 2022

Last verified

Dec, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vivos BioTechnologies, Inc. on 2022-12-22.