Restless leg syndrome (RLS) is an annoying condition that many people experience but struggle to get under control. Sleeping with RLS can feel like your legs are constantly being tugged by an outside force that refuses to stop. There are some drugs available as a treatment option, but for many, especially those already on multiple medications, they are not the optimal solution. Sensory Medical just announced that the FDA has given clearance to its Relaxis device, the first non-drug option to help people with RLS get to sleep.
The Relaxis is a prescription device featuring a pillow sized pad is able to vibrate at different intensities. The pad is positioned below the legs and the patient can activate and control how it jiggles using a connected controller. The vibration induced by the pad seems to provide a counterstimulation to the naturally occurring restless leg sensation, proving itself in studies to help people get better sleep.
From Sensory Medical:
The device provides 30 minutes of vibratory counterstimulation, gradually ramping down and shutting off without waking the patient.
Results from two randomized, multi-center, controlled, double-blinded, prospective clinical research studies published in a peer-reviewed journal article indicated that the Relaxis device was found superior to placebo pads for improving sleep quality in patients with primary RLS.
Sensory Medical Inc. will be exhibiting the new Relaxis system, which will be available on a prescription-only basis in the U.S. starting in the third quarter of 2014, in booth #1018 at SLEEP 2014, the American Academy of Sleep Medicine’s annual meeting of the Associated Professional Sleep Societies, beginning June 2 at the Minneapolis Convention Center.
Product page: The Relaxis Pad For RLS Patients…
Press release: FDA Clears Sensory Medical’s RelaxisTM, First Device for Restless Leg Syndrome…