Dental Appliance to Treat SDB in Children

Vivos BioTechnologies

Status and phase: Enrolling; Phase 4

Conditions: Snoring; Upper Airway Resistance Syndrome; Sleep-Disordered Breathing; Apnea, Obstructive

Treatments: Device: Vivos Grow/Vivos Way Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05661747

VG-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Intervention Arm will use Vivos Grow/Vivos Way Device

Experimental group

Description:

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

Treatment:

Device: Vivos Grow/Vivos Way Device