Sensory Medical has received commercial clearance from the US Food and Drug Administration (FDA) for Relaxis, the first non-pharmacological approach to help improve the quality of sleep in patients with primary restless leg syndrome (RLS).
An estimated 12 million people in the US may be suffering from RLS, a life-long neurological condition that causes discomfort, pain and sleep deprivation, according to the federal National Institute of Neurological Disorders and Stroke (NINDS).
Symptoms of RLS occur mostly while a person is resting and might increase in severity during the night.
NINDS said that many patients find their only relief comes from physical movement, which causes interruption to sleep and leads to physical fatigue, impaired mental functioning and emotional stress.
Relaxis was designed to provide physical relief of RLS, while allowing the patient to remain in bed.
The company said that during an RLS episode, the patient places the low-profile Relaxis pad at the site of their discomfort and chooses a vibration intensity, while the device provides 30 minutes of vibratory counterstimulation, gradually decreasing and shutting-off without waking the patient.
Sensory Medical chief executive officer Fred Burbank said: "Our company was founded solely to find new alternatives for treating RLS, and we are pleased to be the first and only company to have a non-pharmacological approach, clinically proven and FDA-cleared, to improve sleep by addressing symptoms of this devastating condition."
RLS can affect both adults and children, although the condition is twice as prevalent in women.
The most impacted people of RLS are middle-aged or older, as symptoms tend to increase in both frequency and duration with age.
The company said that in most of the severe cases, RLS attacks may occur several times per night, repeatedly causing interrupted sleep and impaired daytime functioning.
To reduce RLS symptoms, medication therapy is often prescribed, including dopaminergic agents used to treat Parkinson’s disease, anti-convulsants, narcotic opioids, and muscle relaxants and sleep medications such as Benzodiazepines.
Burbank added that said Relaxis represents the first prescription, non-invasive, non-medication alternative for improving quality of sleep in patients with primary RLS.
"Until now, patients’ only options were to suffer unaided through their condition, or face the potential side-effects of long-term medication therapy," Burbank said.
"The total RLS patient population may be considerably underestimated, as NINDS reports some individuals avoid seeking medical attention because they do not believe their condition is treatable, and the condition may be misdiagnosed as insomnia, stress, arthritis, muscle cramps, or attributed to the ‘normal effects’ of ageing."
FDA-clearance is based on results from two randomised, multi-centre, controlled, double-blinded, prospective clinical research trials, where the Relaxis device was found to be superior to placebo pads for improving sleep quality in patients with primary RLS.