United States – Those who are obese may not receive any benefit from this recently available nerve-stimulation treatment for the modulation of sleep apnea that the study reports.
Weight and Treatment Efficacy
The researchers discovered that the efficacy of treatment is predicted to decrease by approximately two-thirds in obese patients with BMIs of 32-35 compared to those with lower BMIs, as reported by HealthDay.
“Our research indicates that the likelihood of nerve-stimulation therapy being successful in treating sleep apnea decreases with increased weight,” stated lead investigator Dr. Eric Landsness, an assistant professor of neurology at the Washington University School of Medicine in St. Louis.
Landsness said in a university news release, “I’m not saying that we shouldn’t put this device in patients with a BMI of 38 or 40.” However, as a doctor, it is my responsibility to educate my obese patients so they may make an informed choice, understand their chances of success, and accept the possibility that their chances of success may be very low.
At first, a similar technique, hypoglossal nerve stimulation, which was approved in 2014 for sleep apnea patients whose weight was in healthy ranges, was used in research and introduced as background data.
The scope of this approval has now been widened to patients with BMI up to 40 which is regarded as morbid obesity. Healthy BMI fallen between 18.5 and 24.9 whereas 25 to 29.9 is known as overweight.
Sleep apnea emerges when the muscles in the mouth and throat let go while a person sleeps. Mouth slumping can partially or completely obstruct the airway, with people with large tongues, strong necks and narrow throat ways being at a higher risk.
These obstructions then make people unable to breathe, making them so scared they simply are woken up gasping for their breath. This cycle continues through the night, destroying good sleep and contributing to headaches, strokes, arrhythmia, and other heart-related problems.
The therapy uses a tiny battery-operated device implanted just above the ribs that gives short pulses of electricity to stop the nerve called the hypoglossal, which controls the tongue muscles that open the upper airway during sleep.
In every breath during the treatment, the device sends an electrical impulse to the hypoglossal nerve, causing the tongue to move forward and push the airway clear of obstruction, resulting in unnatural breathing; such an impulse, said the researchers.
Advantages Over CPAP Machines
Scientists pointed out that such a device provides a choice to the sleep apnea patients who would rather not use the CPAP machine, which is the most widespread treatment for this condition.
CPAP machines facilitate the breathing process by creating an open airway and delivering air through the clothing hose and mask.
The machines work well; however, they are noisy and too uncomfortable according to researchers. In fact, over 50% of people who begin a CPAP treatment stop using it at some point.
The FDA recently expanded the qualification criteria to permit hypoglossal nerve stimulation in heavier patients, and Medicare now pays for the device for patients with BMIs up to 35.
Whether or not the therapy will work for overweight or obese patients will be determined by the device being used on 78 participants with a BMI of up to 35 and being recruited between 2019 and 2023.
Overall, the device worked. Three out of four cases showed a statistically significant improvement in their sleep apnea, and the majority of the study cohort reported symptomatic improvement of at least 50%.
The indicator suggests that during this time, patients with a BMI of 32 to 35 did not show as much improvement as patients with lower BMIs.
Study Findings and Implications
The publication of the results occurred to JAMA Otolaryngology-Head & Neck Surgery on April 4.
“Body mass index is clearly an important factor in predicting whether hypoglossal nerve stimulation will work for an individual patient,” Landsness said. “Our study shows an almost linear relationship between BMI and treatment success. For every unit of BMI increase over 32, the odds of successful treatment decrease by about 17%.”
The device is manufactured by Inspire Medical Systems company and its only approved device of the kind in the United States by FDA. It has been estimated that more than 50000 of people worldwide will get the device put in.
Manufacturer and Cost Information
The device will be inserted during a reasonably easy procedure stage that is done in an ambulatory setting, as indicated by the researchers. It may cost the people without insurance between USD 50k to USD 100k out of their own pocket. It is about 12 months, though, to get to its full potential for one person, as reported by HealthDay.
“We have patients coming to us who really want this treatment because they view it as a life-changing alternative to CPAP,” Landsness said. “It certainly can work for some people, but we don’t want to recommend it to patients if there’s a chance their BMIs will affect the device’s usefulness.”