SnoringPhase 4NCT05661747
Dental Appliance to Treat SDB in Children
A Phase 4 study testing Vivos Grow/Vivos Way Device in people with Snoring and Apnea, Obstructive, run by Vivos BioTechnologies, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Snoring, Apnea, Obstructive, Upper Airway Resistance Syndrome
- What is being tested?
- Vivos Grow/Vivos Way Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 May 2022to 31 Mar 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
Breathing and Sleep Center
Colorado Springs, Colorado, 80918
Kevin Goles, DDS, 719-204-8201, kevin@breathingandsleepcenter.com
- Not yet recruiting
Musso Family Dentistry
Garland, Texas, 75401
Mark Musso, DDS, 972-840-8477, drmusso@sbcglobal.net
- Recruiting
New Teeth Dental Solutions
League City, Texas, 77573
Kalli Hale, DDS, 281-554-9090, kallihale@gmail.com
- Recruiting
Emerald Coast Dental Spa and Sleep Medicine
Panama City Beach, Florida, 32408
Tara Griffen, DDS, 972-840-8477, taragriffenmd@gmail.com
About this study
Official title: Use of Intraoral Device to Treat Snoring, Sleep Apnea, and Other Symptoms of Sleep-Disordered Breathing in Children
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.
Read the 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.
- Being tested
- Vivos Grow/Vivos Way Device
- Medical subject headings
- Snoring, Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivos Grow/Vivos Way DeviceDevice
Children already using the device will be monitored to determined whether it improves symptoms of SDB
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm will use Vivos Grow/Vivos Way Device | Experimental | This intervention will compare measurements prior to treatment with measurements post-treatment. Receives: Device: Vivos Grow/Vivos Way Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: An initial evaluation before treatment and upon completion of the study (an average of 1 year)
Secondary outcomes (2)
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.
Measured: 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.
Measured: An initial evaluation before treatment and upon completion of the study (an average of 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start3 May 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SnoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The patient will serve as their own control.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vivos BioTechnologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Musso, DDS, Principal investigator, Musso Family Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661747
- Sponsor's protocol ID
- VG-01
- Status last verified
- Dec 2022
- First submitted
- 14 Dec 2022
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 40526156
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Intraoral Device to Treat Snoring, Sleep Apnea, and Other Symptoms of Sleep-Disordered Breathing in Children
- ClinicalTrials.gov ID
- NCT05661747
- Acronym / sponsor ID
- VG-01
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Vivos BioTechnologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 May 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 22 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The patient will serve as their own control.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm will use Vivos Grow/Vivos Way Device | Experimental | Device: Vivos Grow/Vivos Way DeviceThis intervention will compare measurements prior to treatment with measurements post-treatment. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vivos Grow/Vivos Way DeviceChildren already using the device will be monitored to determined whether it improves symptoms of SDB | Device | Intervention Arm will use Vivos Grow/Vivos Way Device |
Primary outcome
Pediatric Sleep Questionnaire
Time frame: An initial evaluation before treatment and upon completion of the study (an average of 1 year)
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.
Sleep Study
Time frame: An initial evaluation before treatment and upon completion of the study (an average of 1 year)
A home sleep study before and after treatment to assess any changes in sleep disturbance.
2 secondary outcomes
Sleep Related Breathing Disordered Questionnaire (SRBD)
Time frame: An initial evaluation before treatment and upon completion of the study (an average of 1 year)
Airway Volume
Time frame: An initial evaluation before treatment and upon completion of the study (an average of 1 year)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Derived from this study: PubMed 40526156Kushida 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.
- Individual participant dataSharing planned: No
Related trials for Snoring
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
RecruitingObservational study
Prediction of Tongue Base Obstruction During Sleep
Obstructive Sleep Disordered Breathing
Active, not recruiting
The Impact of Technology in Obstructive Sleep Apnea Myofunctional Therapy
Obstructive Sleep Apnea (OSA), Snoring
Active, not recruiting
DISE: Phenotyping Obstruction Patterns
Obstructive Sleep Apnea
RecruitingPhase 1
Use of Passive Myofunctional Appliances for Snoring and Mild Obstructive Sleep Apnea
Sleep Apnea, Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Musso, DDS principal investigator
Musso Family Dentistry
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vivos Grow/Vivos Way Device in people with Snoring and Apnea, Obstructive, run by Vivos BioTechnologies, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Colette Cozean, Ph.D. (19498552885, colettecozean@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Sleep Questionnaire (time frame: An initial evaluation before treatment and upon completion of the study (an average of 1 year)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05661747, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.