A new study has shown that an implanted device that stimulates the tongue nerves holds promise for reducing their sleep disturbances, Daily MedNews reports..
About 80% of children with Down syndrome have obstructive sleep apnea compared to 5% of children without Down syndrome. Treatment, including removal of the adenoids and tonsils, is often ineffective. People with sleep apnea often stop and start breathing during sleep. They wake up rested and struggle with daytime fatigue, according to Pannochka, an online publication for girls and women aged 14 to 35.. net A device called a hypoglossal nerve stimulator has already been approved by the US Food and Drug Administration for adults with sleep apnea who cannot use continuous positive airway pressure (CPAP) therapy..
The device is surgically implanted on an outpatient basis. When it senses that the user is trying to breathe in, it sends an electrical impulse to the hypoglossal nerve, which controls the tongue.. This causes the tongue to move forward in the mouth, opening up the person's airway.. In this new work, the device was tested on young people with Down syndrome aged 10 to 22..
“This study was born out of disappointment in the lack of an effective treatment option for children with Down syndrome who are struggling with sleep apnea,” said lead author Dr. Christopher Hartnick, director of pediatric otolaryngology at the Massachusetts Eye and Ear Infirmary in Boston.. – Sleep apnea significantly affects these children, often affecting their language, behavior and ability to do well in school. Any reduction in these areas is critical for families and our research suggests we may finally be able to help.”.
Researchers conducted a phase I clinical trial that was the first trial of the device in children with Down syndrome. It included 42 participants with severe obstructive sleep apnea at five US medical centers.. Patients were followed up for one year after surgery for implantation of the hypoglossal nerve stimulator.
After one year, 66% of patients responded well to treatment. On average, patients experienced a greater than 51% reduction in apnea per hour.
Quality of life surveys completed by patients' parents showed significant improvements in daily functioning, behavior and speech of patients.
In general, the device was safe. According to the results of the study, the most common side effect was tongue discomfort in five patients, which usually resolved after a few weeks.. The results were published in JAMA Otolaryngology – Head \u0026 Neck Surgery..
Researchers Plan More Clinical Trials to Gather Enough Data to Get FDA Approval for a Device for Children Under 18 With Down Syndrome.
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