Dental Appliance for Sleep Apnea in Children

Phase 4

Recruiting

Led By Mark Musso, DDS

Research Sponsored by Vivos BioTechnologies, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Over the age of 6 and under the age of 18 years

Permanent dentition or mixed dentition at time of evaluation

Must not have

Severe obstructive sleep apnea (AHI> 10/hr)

Enlarged tonsils of a Grade 4 (>75% of space between pillars)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up an initial evaluation before treatment and upon completion of the study (an average of 1 year)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial tests if a mouthguard can reduce sleep-disordered breathing in kids.

Who is the study for?

This trial is for children aged 6-18 in the U.S. with sleep-disordered breathing symptoms like snoring or mild to moderate obstructive sleep apnea, who are also getting orthodontic treatment. They must have good oral hygiene and not have severe respiratory conditions, uncontrolled diabetes, braces already on, very large tonsils, or TMJ issues.

What is being tested?

The study is testing if a marketed mouthguard (Vivos Grow/Vivos Way Device) can help reduce symptoms of sleep-disordered breathing in children when used alongside their orthodontic treatment.

What are the potential side effects?

Potential side effects may include discomfort from wearing the device, changes in bite alignment over time, soreness in teeth or jaws, and possible irritation inside the mouth.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 6 and 18 years old.

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I have all permanent teeth or a mix of permanent and baby teeth.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe sleep apnea with more than 10 interruptions per hour.

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My tonsils are very large, taking up most of the space in my throat.

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I do not have severe asthma, emphysema, COPD, or similar breathing problems.

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My diabetes is not under control.

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I have poor dental health.

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I have been diagnosed with a TMJ condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ an initial evaluation before treatment and upon completion of the study (an average of 1 year)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~an initial evaluation before treatment and upon completion of the study (an average of 1 year)

This trial's timeline: 3 weeks for screening, Varies for treatment, and an initial evaluation before treatment and upon completion of the study (an average of 1 year) for reporting.