Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
50 participants
INTERVENTIONAL
2022-05-03
2025-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention Arm will use Vivos Grow/Vivos Way Device
This intervention will compare measurements prior to treatment with measurements post-treatment.
Vivos Grow/Vivos Way Device
Children already using the device will be monitored to determined whether it improves symptoms of SDB
Interventions
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Vivos Grow/Vivos Way Device
Children already using the device will be monitored to determined whether it improves symptoms of SDB
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
7 Years
17 Years
ALL
No
Sponsors
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Vivos BioTechnologies, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Musso, DDS
Role: PRINCIPAL_INVESTIGATOR
Musso Family Dentistry
Locations
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Breathing and Sleep Center
Colorado Springs, Colorado, United States
Emerald Coast Dental Spa and Sleep Medicine
Panama City Beach, Florida, United States
Musso Family Dentistry
Garland, Texas, United States
New Teeth Dental Solutions
League City, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Kevin Goles, DDS
Role: primary
Tara Griffen, DDS
Role: primary
Mark Musso, DDS
Role: primary
Kalli Hale, DDS
Role: primary
References
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Kushida CA, Stevens J, Bennett M, Heit T, Klemp D, Raio D, Cozean J, Cozean C. Multicenter clinical trial for the treatment of obstructive sleep apnea with a non-permanent orthodontic intraoral device in children. Eur J Pediatr. 2025 Jun 17;184(7):424. doi: 10.1007/s00431-025-06254-x.
Other Identifiers
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VG-01
Identifier Type: -
Identifier Source: org_study_id