A Phase 4 interventional study of Vivos Grow/Vivos Way Device in Snoring, Apnea, Obstructive and Upper Airway Resistance Syndrome, sponsored by Vivos BioTechnologies, Inc.. Status unknown at 4 sites in United States. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2022-12-22.
Sponsored by Vivos BioTechnologies, Inc. · Phase 4, Interventional, and Treatment
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.
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.
122 studies on the registry are indexed under Snoring; 15 are open to participants now.
This study's planned enrollment of 50 is above the median of 43 across 95 interventional studies indexed under Snoring.
Browse Snoring studies →This is the only study on the registry with Vivos BioTechnologies, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This intervention will compare measurements prior to treatment with measurements post-treatment.
Device: Vivos Grow/Vivos Way Device
Children already using the device will be monitored to determined whether it improves symptoms of SDB
Pediatric Sleep Questionnaire
Validated questionnaire for determining sleep-related breathing disorders, snoring, and behavior in childrne. The change in score on the PSQ will be assessed. It is scored from 0-1 with higher scores indicating increased symptoms of sleep disturbance and sleep-disordered breathing. Each question is tallied and an average of all answers (from 3 different subsections) gives the final score.
Time frame: An initial evaluation before treatment and upon completion of the study (an average of 1 year)
Sleep Study
A home sleep study before and after treatment to assess any changes in sleep disturbance.
Time frame: An initial evaluation before treatment and upon completion of the study (an average of 1 year)
Sleep Related Breathing Disordered Questionnaire (SRBD)
A validated subsection of the PSQ, the change in SRBD score will be assessed. It is a 22-questions subset of the PSQ, also graded from 0-1 with scores rising as symptoms of SDB increase.
Time frame: An initial evaluation before treatment and upon completion of the study (an average of 1 year)
Airway Volume
Measured using a 3D cone beam scan, the change in airway volume will be assessed.
Time frame: An initial evaluation before treatment and upon completion of the study (an average of 1 year)
Plan to share: No
No publications or documents are linked to this record.
Started May 2022 (actual). Primary completion is estimated for Dec 2024, 31 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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