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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm will use Vivos Grow/Vivos Way Device | Experimental | This intervention will compare measurements prior to treatment with measurements post-treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vivos Grow/Vivos Way Device | Device | Children already using the device will be monitored to determined whether it improves symptoms of SDB |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | An initial evaluation before treatment and upon completion of the study (an average of 1 year) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | An initial evaluation before treatment and upon completion of the study (an average of 1 year) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Colette Cozean, Ph.D. | Contact | 19498552885 | colettecozean@gmail.com | |
| Mark Musso, DDS | Contact | 972-840-8477 | drmusso@sbcglobal.net |
| Name | Affiliation | Role |
|---|---|---|
| Mark Musso, DDS | Musso Family Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Breathing and Sleep Center | Recruiting | Colorado Springs | Colorado | 80918 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40526156 | Derived | 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. |
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| ID | Term |
|---|---|
| D012913 | Snoring |
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D012135 | Respiratory Sounds |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The patient will serve as their own control.
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No masking is possible, as each child will serve as their own control in using the mouthguard, and their progress will be compared to their measurements prior to beginning the trial.
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| Airway Volume |
Measured using a 3D cone beam scan, the change in airway volume will be assessed. |
| An initial evaluation before treatment and upon completion of the study (an average of 1 year) |
| Emerald Coast Dental Spa and Sleep Medicine | Recruiting | Panama City Beach | Florida | 32408 | United States |
|
| Musso Family Dentistry | Not yet recruiting | Garland | Texas | 75401 | United States |
|
| New Teeth Dental Solutions | Recruiting | League City | Texas | 77573 | United States |
|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |