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FDA-Cleared Therapy for Pediatric Sleep Apnea From Vivos Offers Parents and Providers New Hope


News provided by

Vivos Therapeutics

Dec 16, 2024, 08:15 ET

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VIVOS PRS 3
VIVOS PRS 3

Strongly linked to attention disorders like ADHD, untreated pediatric OSA can significantly impact a child's development and long-term well-being. Vivos Therapeutics, with its groundbreaking FDA-cleared treatments, is leading the charge in tackling this silent epidemic with innovative, non-surgical solutions that promise transformative health outcomes for children and their families.

LITTLETON, Colo., Dec. 16, 2024 /PRNewswire-PRWeb/ -- Pediatric Obstructive Sleep Apnea (OSA) is a silent health crisis affecting an estimated 10 million children in the United States, with studies showing that those who snore have a 20% chance of developing the condition. (1) Left untreated, it can impair cognitive development and increase long-term risks such as attention deficit disorders. Despite its prevalence, awareness remains critically low. "After decades of research, many parents—and even pediatricians—still underestimate the chronic and harmful nature of OSA, often dismissing symptoms without proper evaluation," states Kirk Huntsman, CEO of Vivos Therapeutics.

The Complex Link Between Pediatric OSA and ADHD: An Overlapping Challenge
Research shows that Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms overlap significantly with OSA, with attention deficits reported in up to 95% of children diagnosed with this sleep-related breathing disorder. The relationship appears to be reciprocal, as OSA exacerbates ADHD symptoms, and vice versa. (2)

"Our technology represents the first FDA-cleared, highly effective, non-surgical alternative for kids aged 6 to 17 with moderate to severe OSA" — Kirk Huntsman, CEO of Vivos Therapeutics.

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Studies have also shown that children with OSA often display behaviors commonly associated with ADHD, such as hyperactivity, impulsivity, and inattention. Moreover, researchers have identified OSA as one of several "sleep phenotypes" linked to ADHD—distinct patterns of sleep-related issues that may contribute to the condition. These include delayed sleep onset and restless legs syndrome, which are commonly observed in children with ADHD. (3)

"The overlap between these conditions underscores the critical need for early and accurate diagnosis followed by effective treatment," emphasizes Huntsman. "Unfortunately, too many pediatricians and family physicians fail to consider breathing and sleep disorders when evaluating a child with common challenges. Early intervention with our technology can not only restore a child's ability to thrive at home and school but can also improve their odds of a lifetime of breathing freely and sleeping deeply."

Spotting the Hidden Signs of Pediatric OSA
Children experience OSA in ways that differ significantly from adults, with distinct risk factors and symptoms. Unlike adults, whose OSA is often linked to obesity or unhealthy habits such as smoking or excessive drinking, children are more likely to develop the condition due to enlarged tonsils or adenoids, making prevention particularly challenging.

Understanding these differences is crucial to identifying and addressing OSA early, paving the way for proper treatment. Common symptoms of OSA in children include:

  • ADHD symptoms
  • Snoring
  • Mouth breathing
  • Pauses in breathing
  • Restless sleep / Frequent arousals
  • Snorting, gasping, coughing or choking
  • Night Terrors
  • Nighttime sweating
  • Bed-wetting (4)

The Lifelong Impact of Early OSA Treatment in Children
Early intervention in treating pediatric OSA offers a pathway to lasting health improvements. Research has shown that effective treatment can lead to significant reductions in ADHD symptoms within just 2 to 6 months.

Treatment has also been linked to:

  • Improved Cognitive Function: Better oxygenation during sleep enhances brain development, aiding memory and learning.
  • Better Academic Performance: Quality sleep fosters improved focus, attention, and engagement in the classroom.
  • Reduced Health Risks: Proper airway function lowers the likelihood of developing chronic conditions such as allergies, hypertension and diabetes.

A Groundbreaking FDA Clearance: Redefining Pediatric OSA Treatment
Last August, Vivos reached a groundbreaking milestone: the first FDA 510(k) clearance for its Vivos CARE Oral Medical Device to treat moderate to severe OSA in children ages 6 to 17. This innovative, non-surgical solution provides families with an effective way to protect their children's health and futures. Other Vivos solutions are available for younger children and adults.

Clinical data submitted to the FDA highlighted the effectiveness of the Vivos CARE device, with 97% of adult patients experiencing relief from OSA symptoms. Of these, 80% showed at least a 50% improvement or a reduction in severity by one category, while 28% achieved full resolution of their OSA. Treatment durations averaged just 9.7 months, with no need for additional interventions. Similar positive outcomes have also been observed in children.

"Children suffering from sleep related breathing disorders such as OSA are typically referred for surgical removal of tonsils and adenoids. Our technology represents the first FDA-cleared, highly effective, non-surgical alternative for kids aged 6 to 17 with moderate to severe OSA. Parents and providers have been waiting for this breakthrough for many years" says Huntsman. "It's already changing the face of treatment and the future of thousands of kids."

About VIVOS THERAPEUTICS 
Obstructive sleep apnea (OSA) affects over 1 billion people worldwide, yet 85% remain undiagnosed and unaware of their condition. This chronic disorder is not just a sleep issue—it's closely linked to nearly every modern chronic health condition. While the medical community has made strides in treating sleep disorders, breathing and sleep health remain areas that are still not fully understood. As a result, solutions are often mechanistic and fail to address the root causes of OSA. 

Vivos Therapeutics, founded in 2016 and based in Littleton, CO, is changing this. Through innovative technology, education, and partnerships with dentists, functional medicine doctors, and sleep specialists, Vivos is empowering healthcare providers to more thoroughly address the complex needs of patients. Their groundbreaking device is the only FDA 510(k) cleared technology for treating severe OSA and the first to receive clearance for treating moderate to severe OSA in children. 

The Vivos Method offers a unique, clinically effective solution that is nonsurgical, noninvasive, and nonpharmaceutical, providing hope for patients with mild to severe OSA. Vivos: Breathe New Life. For more information, visit http://www.vivos.com. 

References
1. "Pediatric Obstructive Sleep Apnea." Yale Medicine, yalemedicine.org/conditions/pediatric-obstructive-sleep-apnea.
2. Urbano, Gino Luis, et al. "The Link between Pediatric Obstructive Sleep Apnea (OSA) and Attention Deficit Hyperactivity Disorder (ADHD)." Children, vol. 8, no. 9, 19 Sept. 2021, p. 824, doi.org/10.3390/children8090824.
3. Sedky, Karim, et al. "Attention Deficit Hyperactivity Disorder and Sleep Disordered Breathing in Pediatric Populations: A Meta-Analysis." Sleep Medicine Reviews, vol. 18, no. 4, Aug. 2014, pp. 349–356, doi.org/10.1016/j.smrv.2013.12.003. Accessed 9 Jan. 2020.
4. "Pediatric Obstructive Sleep Apnea"; mayoclinic.org/diseases-conditions/pediatric-sleep-apnea/symptoms-causes/syc-20376196.

Media Inquiries: 
Karla Jo Helms 
JOTO PR™ 
727-777-4629 
jotopr.com 
[email protected] 

SOURCE Vivos Therapeutics

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