RT’s Three Key Takeaways:
- The eligibility for hypoglossal nerve stimulation remedy for obstructive sleep apnea consists of sufferers with BMIs as much as 40.
- Analysis from Washington College College of Medication suggests the chance of profitable remedy decreases as a affected person’s BMI will increase, with a very famous drop in efficacy for sufferers with BMIs of 32 to 35.
- The Encourage system, the one FDA-approved hypoglossal nerve-stimulation system for sleep apnea, has been implanted in about 50,000 sufferers worldwide.
A nerve-stimulation remedy for obstructive sleep apnea that initially was accepted just for individuals with physique mass indexes (BMIs) within the wholesome vary not too long ago was prolonged to sufferers with BMIs as much as 40, a weight vary usually described as severely overweight. A wholesome BMI ranges from 18.5 to 24.9.
The expanded eligibility standards for the remedy present extra sleep apnea sufferers with entry to the more and more in style remedy, referred to as hypoglossal nerve stimulation. Nonetheless, new analysis from Washington College College of Medication signifies that the chance of profitable nerve-stimulation remedy drops considerably as a affected person’s weight rises above a wholesome vary.
The examine, which seems JAMA Otolaryngology-Head & Neck Surgical procedure, is predicated on a retrospective evaluation of remedy success in 76 sleep apnea sufferers with BMIs of lower than 35.
“Our examine reveals that the extra chubby you’re, the much less probably it’s that nerve-stimulation remedy might be efficient in treating your sleep apnea,” says senior writer Eric C. Landsness, MD, PhD, an assistant professor of neurology, in a launch. “I’m not saying that we shouldn’t put this system in sufferers with a BMI of 38 or 40. However my job as a doctor is to assist chubby sufferers make an knowledgeable determination, to higher perceive their odds of success and understand that the possibilities of it working for them could also be loads much less.”
An Interesting Different to CPAP
Sleep apnea most frequently is handled with a steady optimistic airway stress (CPAP) machine. CPAP machines are efficient, however they are often loud and uncomfortable and are largely unpopular. About half of those that attempt the method fail to keep it up, in accordance with a launch from Washington College College of Medication.
To many sufferers, hypoglossal nerve stimulation appears like an interesting different to CPAP machines. The remedy is pushed by a small, battery-operated system implanted simply above the ribs. A small wire is run internally up the chest and into the jaw, the place it connects to the hypoglossal, a nerve that controls tongue muscular tissues liable for preserving the higher airway open throughout sleep.
Every time the affected person takes a breath, the system delivers electrical impulses to the hypoglossal nerve, inflicting the tongue to maneuver ahead simply far sufficient to keep away from the airway blockages that drive sleep apnea.
Increasing BMI
The primary hypoglossal nerve-stimulation system (model identify Encourage) was accepted by the US Meals and Drug Administration (FDA) in 2014 to be used in sufferers with BMIs lower than 25 whose reasonable to extreme sleep apnea has failed remedy with different, extra established therapies.
Since then, eligibility necessities have loosened, with the FDA now permitting the system for use in sufferers with BMIs as excessive as 40 and Medicare offering protection for sufferers with BMIs as much as 35.
Landsness, a sleep researcher who treats sufferers with sleep apnea, was stunned by the adjustments within the eligibility standards. To know how the system performs in individuals of various sizes, he and colleagues carried out an unbiased analysis utilizing information from 78 individuals with BMIs as much as 35 who obtained implants of the nerve-stimulation system on the Washington College Sleep Medication Heart from 2019 via 2023.
Influence on Therapy Efficacy
The first examine discovering was that, total, the system works. Three out of 4 sufferers confirmed important enchancment in apnea signs within the yr following implantation. Most examine individuals skilled symptom reductions of not less than 50%, with many exhibiting dramatic reductions to near-normal or gentle ranges of sleep apnea.
Nonetheless, amongst chubby examine individuals with BMIs of 32 to 35, the outcomes had been much less optimistic, with the chance of profitable remedy estimated to be 75% decrease than these of examine individuals with decrease BMIs.
“Physique mass index is clearly an vital think about predicting whether or not hypoglossal nerve stimulation will work for a person affected person,” Landsness says in a launch. “Our examine reveals an virtually linear relationship between BMI and remedy success. For each unit of BMI improve over 32, the percentages of profitable remedy lower by about 17%.”
Issues for Therapy
Encourage is the one FDA-approved hypoglossal nerve-stimulation system obtainable in the US. The corporate additionally markets the system in Europe, Japan, and different international locations. Tens of hundreds of sufferers worldwide have been implanted with it.
Implantation of a hypoglossal nerve-stimulation system is a comparatively easy outpatient surgical procedure. Among the many greatest considerations for sufferers are in phrases of time and cash. Landsness estimates that the remedy can value from $50,000 to $100,000 out of pocket with out insurance coverage and take a yr to be totally optimized.
“We have now sufferers coming to us who really need this remedy as a result of they view it as a life-changing different to CPAP,” Landsness says in a launch. “It definitely can work for some individuals, however we don’t need to suggest it to sufferers if there’s an opportunity their BMIs will have an effect on the system’s usefulness.”
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