NCT05661747

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2022

Typical duration for phase_4

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 22, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

December 22, 2022

Status Verified

December 1, 2022

Enrollment Period

2.7 years

First QC Date

December 14, 2022

Last Update Submit

December 14, 2022

Conditions

SnoringApnea, ObstructiveUpper Airway Resistance SyndromeSleep-Disordered Breathing

Outcome Measures

Primary Outcomes (2)

  • 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)

Secondary Outcomes (2)

  • Sleep Related Breathing Disordered Questionnaire (SRBD)

    An initial evaluation before treatment and upon completion of the study (an average of 1 year)

  • Airway Volume

    An initial evaluation before treatment and upon completion of the study (an average of 1 year)

Study Arms (1)

Intervention Arm will use Vivos Grow/Vivos Way Device

EXPERIMENTAL

This intervention will compare measurements prior to treatment with measurements post-treatment.

Device: Vivos Grow/Vivos Way Device

Interventions

Vivos Grow/Vivos Way DeviceDEVICE

Children already using the device will be monitored to determined whether it improves symptoms of SDB

Intervention Arm will use Vivos Grow/Vivos Way Device

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Breathing and Sleep Center

Colorado Springs, Colorado, 80918, United States

RECRUITING

Emerald Coast Dental Spa and Sleep Medicine

Panama City Beach, Florida, 32408, United States

RECRUITING

Musso Family Dentistry

Garland, Texas, 75401, United States

NOT YET RECRUITING

New Teeth Dental Solutions

League City, Texas, 77573, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40526156DERIVED

MeSH Terms

Conditions

SnoringSleep Apnea, ObstructiveSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Respiratory SoundsSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Mark Musso, DDS

    Musso Family Dentistry

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Colette Cozean, Ph.D.

CONTACT

19498552885colettecozean@gmail.com

Mark Musso, DDS

CONTACT

972-840-8477drmusso@sbcglobal.net

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Masking Details
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.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The patient will serve as their own control.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2022

First Posted

December 22, 2022

Study Start

May 3, 2022

Primary Completion

December 31, 2024

Study Completion

March 31, 2025

Last Updated

December 22, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

US(4)