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For kids with Down syndrome, a new device offers hope for sleep problems

April 21, 2022
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For kids with Down syndrome, a new device offers hope for sleep problems
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Okayate Dougherty pairs all of her son Elliot’s physician’s appointments with a deal with, like a visit to his favourite lunch spot or knowledgeable bull using present — one among Elliot’s favourite sports activities, proper behind baseball and basketball. So once they flew from Missouri to Boston in 2018 for Elliot to have a brand new machine implanted into his chest to deal with his sleep apnea, the deal with needed to be huge. Three days after the surgical procedure, Elliot was at his first Pink Sox sport.

Since then, “it’s been a miracle,” his mom stated.

13-year-old Elliot, who has Down syndrome, has handled obstructive sleep apnea for his total life. The problem — which occurs when somebody can’t get sufficient oxygen whereas asleep — affects about 80% of individuals with Down syndrome and might result in mind fog, ADHD-like signs, and a number of different points. The issues can usually be written off as “oh that’s simply Down syndrome,” Dougherty stated. “However there isn’t a ‘that’s simply Down syndrome.”

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Elliot acquired the implant as a part of a Section 1 scientific trial, the outcomes of which have been revealed Thursday in JAMA Otolaryngology — Head & Neck Surgical procedure.


For teenagers with sleep apnea, the primary line of therapy is to take away the tonsils and adenoids. Elliot had this surgical procedure when he was 4 years outdated, and his mom stated it labored for a short while. However the sleep apnea got here again in full power, because it does for a lot of children with Down syndrome who are likely to have greater tongues and decrease muscle tone. The following therapy possibility is a CPAP machine, which makes use of a face masks to maintain an individual’s air stress regular whereas they sleep. However children with Down syndrome even have sensory points or really feel fidgety, and lots of are unable to put on the masks for these or different causes.

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The choices are restricted after that. Some individuals have surgical procedure to cut back their tongue measurement and create area within the airway, however Dougherty didn’t need to resort to that for Elliot.

At a convention on Down syndrome, she heard a few new research to check a tool known as a hypoglossal nerve stimulator. It’s like a pacemaker, implanted within the chest with a direct line to the tongue. The machine — turned on within the evenings utilizing a distant management — stimulates a nerve to maneuver the tongue all through the night time, opening the affected person’s airway.

a chest scan showing an implant in a chest
The machine implanted in Elliot’s chest. Courtesy Dougherty household

The expertise, developed by the Minneapolis-based firm Encourage, earned FDA approval in 2020 for adults with sleep apnea. When pediatric ear, nostril, and throat doctor Christopher Hartnick noticed the primary research of the machine on adults, he realized it might probably assist children with Down syndrome.

“I went to the parents at Encourage and I grew to become that pesky pediatrician who known as many, many instances to say I’ve this inhabitants in want,” stated Hartnick, who practices at Massachusetts Eye and Ear.

In 2015, Hartnick and physicians at 4 different establishments across the nation started a scientific trial in testing the machine in 42 children with Down syndrome and extreme sleep apnea, together with Elliot.

As a result of it was a Section 1 research, the first objective was to make sure the implant was secure. Out of 42 youngsters, there have been few problems — the commonest aspect impact was tongue or mouth discomfort, which occurred in 5 youngsters. However the early outcomes on efficacy have been additionally encouraging. Researchers tracked the change in apnea-hypopnea index, or the variety of instances per hour when somebody isn’t receiving a adequate quantity of oxygen whereas asleep. On common, the machine helped sufferers to have about 50% fewer of those occasions per hour. For 3-quarters of sufferers, the variety of occasions dropped beneath the brink for extreme sleep apnea, which is 10 episodes or extra per night time.

For Dougherty, the change in Elliot’s high quality of life was clear. Elliot, who underwent the process at age 10, can keep up late at sleepovers and skip daytime naps, which he by no means might earlier than. He doesn’t get in hassle at college like he used to, can focus higher, and has seen his speech talents enhance.

“As soon as we have been in a position to get the sleep apnea beneath management, the entire different items started to fall collectively,” Dougherty stated. “I simply can’t think about how significantly better life would have been for Elliot if we might have achieved this sooner.”

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Kishore Vellody, director of the Down Syndrome Heart at UPMC Kids’s Hospital of Pittsburgh, stated that whereas the research solely included a small variety of sufferers, he finds the analysis promising.

“Hopefully, as they add numbers, we begin to see extra of an impact that’s sustained even in bigger populations,” stated Vellody, who wasn’t concerned within the analysis.

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The researchers are planning additional research on the machine, notably round its potential to enhance speech for a affected person with Down syndrome. The groups discovered that many sufferers like Elliot developed improved speech capabilities after the implant, maybe as a result of elevated use of their tongues at night time.

For the machine for use extra broadly in youngsters with Down syndrome, it could have to earn FDA approval.

Tim Herbert, the CEO of Encourage, stated that the corporate is working straight with the FDA to find out which avenue for approval will work greatest. The corporate is fascinated by a broad pediatric approval, however has not stated if it plans to first search approval just for youngsters with Down syndrome. Hartnick stated that if the corporate set their sights on approval for the broader, and maybe extra worthwhile common pediatric inhabitants, fairly than solely on children with Down syndrome, it would require extra analysis — and thus, extra time to attend for households.

“This may increasingly appear to be a small market to you, however it’s a fairly essential market and it’s representational, and if we’ve got to stroll earlier than we run — that’s actually the dialogue that we’re part of,” he stated.

The Dougherty household is grateful for the change the machine has introduced into Elliot’s life. He turns it on by himself each night time, and off within the mornings. When requested what he remembers about getting the implant in Boston, Elliot stated, “it was superior.”

Correction: A earlier model of this story misstated Christopher Hartnick’s affiliation. It’s Massachusetts Eye and Ear. 



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