Clinical trial NCT05661747: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Snoring
Apnea, Obstructive
Upper Airway Resistance Syndrome
Sleep-Disordered Breathing
Lead sponsor: Vivos BioTechnologies, Inc.
Sponsor class: INDUSTRY
First posted: 2022-12-22
Enrollment: 50
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The patient will serve as their own control.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pediatric Sleep Questionnaire
timeFrame: An initial evaluation before treatment and upon completion of the study (an average of 1 year)
measure: Sleep Study
timeFrame: An initial evaluation before treatment and upon completion of the study (an average of 1 year)
Secondary outcomes:
measure: Sleep Related Breathing Disordered Questionnaire (SRBD)
timeFrame: An initial evaluation before treatment and upon completion of the study (an average of 1 year)
measure: Airway Volume
timeFrame: An initial evaluation before treatment and upon completion of the study (an average of 1 year)
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Breathing and Sleep Center
state: Colorado
city: Panama City Beach
country: United States
facility: Emerald Coast Dental Spa and Sleep Medicine
state: Florida
city: Garland
country: United States
facility: Musso Family Dentistry
state: Texas
city: League City
country: United States
facility: New Teeth Dental Solutions
state: Texas
Study officials:
affiliation: Musso Family Dentistry
name: Mark Musso, DDS
role: PRINCIPAL_INVESTIGATOR
References: