The US Food and Drug Administration (FDA) has approved a new device which is used in improving quality of sleep in patients with primary Restless Leg Syndrome (RLS). The announcement of approval has been done by the company on its website.
The device name is “Relax” which has been made by Sensory Medical Inc. The device is a low profile pad; for its use patient lies on the bed and places his or her legs on the pad which provides a vibratory counterstimulation that gradually ramps down and shuts off. Approval is based on a meta-analysis and a pooled analysis of 2 randomized, multicenter clinical trial that has shown that the device was superior compared to placebo pad.
The device is a noninvasive, nonpharmacological alternative or patients who are treated with methods like pharmacological treatment (dopamine agonists, gabapentin enalapril, and opioids for resistant cases) and treatment of causes in secondary RLS. Patients can relieve symptoms through movement which requires patients to get up from the bed and move about. But this could disturb the sleep and patient have to try getting sleep mute times in the night.
Even after being a nonpharmacological device, relaxes has side effects which include worsening of the symptoms, leg cramps, tingling, soreness, pain or motion sickness. Worsening of symptoms is the most common side effect but it resolves within 3 weeks of stopping the use the device.
For more details of Relax device click here