Dental Appliance for Sleep Apnea in Children

Recruiting at 3 trial locations

Overseen By Mark Musso, DDS

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Vivos BioTechnologies, Inc.

Disqualifiers: Poor oral hygiene, Uncontrolled diabetes, Severe sleep apnea, TMJ, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Vivos Grow/Vivos Way Device for sleep apnea in children?

Research shows that dental devices, which move the lower jaw forward, can help reduce symptoms of sleep apnea, such as snoring and breathing interruptions, in both children and adults. These devices have been effective in improving sleep quality by expanding the palate and advancing the jaw, which can help open the airway during sleep. ^{1 2 3 4 5}

Is the dental appliance for sleep apnea safe for children?

Research on similar devices for sleep apnea in adults shows they are generally safe, with some users experiencing mild side effects like sore teeth. However, specific safety data for children using these devices is not provided in the available studies. ^{1 6 7 8 9}

How is the Vivos Grow/Vivos Way Device treatment for sleep apnea in children different from other treatments?

The Vivos Grow/Vivos Way Device is unique because it combines maxillary expansion (widening the upper jaw) and mandibular advancement (moving the lower jaw forward) to improve breathing during sleep, which is different from other treatments that typically focus on just one of these approaches. ^{1 2 4 5 10}

Research Team

Mark Musso, DDS

Principal Investigator

Musso Family Dentistry

Eligibility Criteria

This trial is for children aged 6-18 in the U.S. with sleep-disordered breathing symptoms like snoring or mild to moderate obstructive sleep apnea, who are also getting orthodontic treatment. They must have good oral hygiene and not have severe respiratory conditions, uncontrolled diabetes, braces already on, very large tonsils, or TMJ issues.

Inclusion Criteria

I have been diagnosed with a sleep disorder that affects my breathing.

I am between 6 and 18 years old.

I have decided to undergo orthodontic treatment.

Exclusion Criteria

I have severe sleep apnea with more than 10 interruptions per hour.

My tonsils are very large, taking up most of the space in my throat.

I do not have severe asthma, emphysema, COPD, or similar breathing problems.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Vivos Grow/Vivos Way device to treat sleep-disordered breathing

1 year

Initial evaluation and post-treatment assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Vivos Grow/Vivos Way Device

Trial Overview The study is testing if a marketed mouthguard (Vivos Grow/Vivos Way Device) can help reduce symptoms of sleep-disordered breathing in children when used alongside their orthodontic treatment.

Participant Groups

Group I: Intervention Arm will use Vivos Grow/Vivos Way Device Experimental Treatment 1 Intervention

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

Vivos Grow/Vivos Way Device is already approved in United States for the following indications:

Approved in United States as Vivos CARE devices for:

• Mild to severe obstructive sleep apnea (OSA)

Who Is Running the Clinical Trial?

Vivos BioTechnologies, Inc.

Lead Sponsor

Trials

1

Recruited

50+

Findings from Research

In a study of 103 children with obstructive sleep apnea syndrome (OSAS), treatment with a custom device that combined maxillary expansion and mandibular advancement led to significant improvements in sleep breathing quality after nine months, as indicated by a decrease in the Apnea/Hypopnea Index to ≤5.

Long-term follow-up revealed that 84% of the patients reported no loud or troubled breathing years after treatment, suggesting lasting benefits from the intervention in improving respiratory status during sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary results on the impact of simultaneous palatal expansion and mandibular advancement on the respiratory status recorded during sleep in OSAS children. Remy, F., Bonnaure, P., Moisdon, P., et al.[2021]

The study involving 96 patients with mild to moderate obstructive sleep apnea found that a custom-made oral appliance significantly reduced the apnea-hypopnea index (AHI) and snoring, with 49% of users achieving an AHI below 5 compared to only 11% in the placebo group.

Despite the reduction in sleep apnea severity and snoring, the oral appliance did not lead to significant improvements in daytime sleepiness or quality of life, indicating that while it may help with sleep apnea symptoms, it does not necessarily enhance overall daytime functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral Appliance Therapy in Patients With Daytime Sleepiness and Snoring or Mild to Moderate Sleep Apnea: A Randomized Clinical Trial. Marklund, M., Carlberg, B., Forsgren, L., et al.[2016]

A study involving 58 patients with obstructive sleep apnea found that both a new-generation noncustom mandibular advancement device (MAD) and a custom MAD significantly reduced the apnea-hypopnea index, indicating effective treatment for sleep apnea.

The results showed no significant differences in effectiveness between the noncustom and custom MADs, suggesting that noncustom devices could be a viable option for predicting treatment success and improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Equal effect of a noncustom vs a custom mandibular advancement device in treatment of obstructive sleep apnea. Bosschieter, PFN., Uniken Venema, JAM., Vonk, PE., et al.[2023]

In a study of 20 patients with mild-to-moderate obstructive sleep apnea, both the individually adjustable intraoral sleep apnea device (ISAD) and CPAP significantly improved apnea/hypopnea index (AHI) and breathing-related arousals, but CPAP was more effective in normalizing respiratory parameters after 6 weeks.

Patients found the ISAD easier to use and reported better compliance compared to CPAP, suggesting that while CPAP is more effective long-term, the ISAD may be a beneficial alternative for those who struggle with CPAP adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An individually adjustable oral appliance vs continuous positive airway pressure in mild-to-moderate obstructive sleep apnea syndrome. Randerath, WJ., Heise, M., Hinz, R., et al.[2019]

In a pilot study of 24 adults with loud snoring, a dental device that advances the mandible and increases vertical dimension (device A) significantly reduced the Respiratory Disturbance Index (RDI) by an average of 14.5 events per hour and improved sleepiness scores after 2 weeks of use.

In contrast, a different device that minimally increased vertical opening without mandible protrusion (device B) did not show any improvement in RDI and even resulted in increased scores for some subjects, highlighting the importance of device design in treating obstructive sleep apnea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of two dental devices for treatment of obstructive sleep apnea syndrome (OSAS). Hans, MG., Nelson, S., Luks, VG., et al.[2019]

The mandibular advancement device (MAD) Somnoguard significantly reduced the respiratory disturbance index (RDI) in 44 patients with obstructive sleep apnea (OSA), indicating improved breathing during sleep.

68% of patients experienced either a cure or substantial improvement in their condition, along with a notable increase in minimal oxygen saturation and a decrease in snoring time, demonstrating the device's efficacy as an alternative treatment for those noncompliant with continuous positive airway pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mandibular advancement device for the ENT office to treat obstructive sleep apnea. Maurer, JT., Huber, K., Verse, T., et al.[2013]

In a pilot study of 20 heavy snorers, the Somnoguard mandibular advancement device (MAD) showed a 65% success rate in reducing the apnea-hypopnea index (AHI) by at least 50%, indicating its efficacy in treating mild obstructive sleep apnea (OSA).

The use of the MAD led to significant reductions in both the snoring index and the Epworth Sleepiness Scale scores at both 1-month and 6-month follow-ups, demonstrating its effectiveness and good tolerance as a non-invasive treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of a novel mandibular advancement device for the control of snoring. Vanderveken, OM., Boudewyns, AN., Braem, MJ., et al.[2019]

The anterior mandibular positioning (AMP) device significantly reduced the apnoea-hypopnoea index (AHI) and the percentage of time spent snoring, indicating its efficacy in treating obstructive sleep apnoea and snoring.

While patients reported a statistically significant increase in sore teeth, the side effects were generally mild, with no significant increase in facial pain or other discomforts, suggesting the AMP device is a safe treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anterior mandibular positioning device for treatment of snoring and obstructive sleep apnoea. Faber, CE., Grymer, L., Hjorth, T.[2004]

A study involving 80 patients with varying degrees of sleep apnea showed that a built-in thermal sensor in a mandibular advancement device (MAD) provided highly reliable data on device usage, comparable to self-reported diaries.

The analysis of 30 nights of MAD use revealed a very high reliability score (ICC3,1 0.847), indicating that digital tracking can enhance the accuracy of adherence measurements for patients using MADs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability of an adherence monitoring sensor embedded in an oral appliance used for treatment of obstructive sleep apnoea. Gjerde, K., Lehmann, S., Naterstad, IF., et al.[2018]

The use of a mandibular advancement intraoral appliance (MOA) in 18 pediatric patients with obstructive sleep apnea syndrome (OSAS) led to a significant reduction in respiratory disturbance index (RDI) from 10 to 4.5 events per hour and an increase in minimum oxygen saturation (SpO2) from 82.6% to 88.9% over 60 days.

The MOA also significantly decreased total snoring events and improved various sleep disorder symptoms without altering signs of temporomandibular disorders, suggesting it can be an effective alternative treatment for OSAS in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a mandibular advancement intraoral appliance (MOA) for the treatment of obstructive sleep apnea syndrome (OSAS) in pediatric patients: A pilot-study. Modesti-Vedolin, G., Chies, C., Chaves-Fagondes, S., et al.[2019]

References

1. France pubmed.ncbi.nlm.nih.gov

Preliminary results on the impact of simultaneous palatal expansion and mandibular advancement on the respiratory status recorded during sleep in OSAS children. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Oral Appliance Therapy in Patients With Daytime Sleepiness and Snoring or Mild to Moderate Sleep Apnea: A Randomized Clinical Trial. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Equal effect of a noncustom vs a custom mandibular advancement device in treatment of obstructive sleep apnea. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

An individually adjustable oral appliance vs continuous positive airway pressure in mild-to-moderate obstructive sleep apnea syndrome. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Comparison of two dental devices for treatment of obstructive sleep apnea syndrome (OSAS). [2019]

6. England pubmed.ncbi.nlm.nih.gov

A mandibular advancement device for the ENT office to treat obstructive sleep apnea. [2013]

7. England pubmed.ncbi.nlm.nih.gov

Pilot study of a novel mandibular advancement device for the control of snoring. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Anterior mandibular positioning device for treatment of snoring and obstructive sleep apnoea. [2004]

9. England pubmed.ncbi.nlm.nih.gov

Reliability of an adherence monitoring sensor embedded in an oral appliance used for treatment of obstructive sleep apnoea. [2018]

10. Spain pubmed.ncbi.nlm.nih.gov

Efficacy of a mandibular advancement intraoral appliance (MOA) for the treatment of obstructive sleep apnea syndrome (OSAS) in pediatric patients: A pilot-study. [2019]