Relaxis™ For RLS Patients
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What is Relaxis?
Relaxis is a medical device which uses vibration (also known as counterstimulation) to compete with and diminish the unpleasant sensations of RLS. It consists of a soft, flat pillow-like pad with six small, but powerful motors strong enough to overwhelm moderate to severe RLS symptoms. The pad is connected to a controller. The controller allows you to turn the device on and off as well as adjust the intensity. Another cord connects the controller to a simple wall plug that plugs into any standard home outlet.
Relaxis is very easy to use. You simply plug it in, lie in a comfortable position on your bed, and place the device under the affected area. Then turn it on and adjust the intensity to a level that feels comfortable for you and competes with your RLS symptoms. Then lie back, take a deep breath, and focus on the pleasant vibration so you can fall asleep. Relaxis is programmed to run for 30 minutes, after which it will gently ramp down in intensity then shut itself off so it won’t awaken you once you’ve fallen asleep.
In 2014, Relaxis was cleared by the United States FDA for improved sleep in patients with primary RLS. To obtain the device, a doctor’s prescription is required. Talk to your doctor to see if Relaxis is right for you.
Improve Sleep with Relaxis
For patients with RLS, getting a good night’s sleep is a challenge. Between interruption of sleep and having to get out of bed to make RLS symptoms go away, restful sleep can seem like it’s only a dream. While some drugs may provide some relief from RLS symptoms, not all patients are comfortable with, or able to take, medications. For some patients, the side effects of RLS drugs and the cost of monthly prescriptions can be prohibitive.
Although patients can relieve some of their symptoms through movement, “movement” requires that patients get up from bed and move about. By the time patients relieve their discomfort and return to bed, they often feel “awake.” Falling back to sleep can be difficult, especially if a patient experiences another RLS episode while trying a second or even third time to go back to sleep. Relaxis was designed so that patients could easily address their RLS symptoms while remaining in bed, lying down. It is intended to eliminate the need to get up and move about so that patients can return quickly and easily to a restful sleep.
Relaxis is the first FDA-cleared device, which has been tested in two multi-center, double-blind, clinical studies and peer reviewed in four papers. It uses specific vibrations to disrupt RLS symptoms in the comfort of your own bed, when needed. With Relaxis there’s no need to get out of bed to make the symptoms go away. Instead you can lay in bed with Relaxis under the affected area and experience relief of your RLS symptoms.
“First In Class”
The original use of vibration for the relief of pain and discomfort was first proven in 1964. Now, that technique, coupled with years of medical device research and development to relieve RLS symptoms, have come together for a prescription-based treatment for your RLS symptoms. The Relaxis device is “First In Class,” which means Relaxis is the the first FDA-cleared, non-drug therapy for people with moderate to severe RLS. In clinical studies, Relaxis was found to help alleviate symptoms of RLS and improve sleep for people who suffer from primary RLS.
Please contact Sensory Medical, Inc. for additional information.
How Relaxis Works
During a nighttime RLS attack, you can place and activate the Relaxis under the location where you experience the greatest degree of discomfort. Part of the smart design of Relaxis is its automatic shut-off and ramp-down feature. The vibration from the pad (a form of counterstimulation) runs for approximately 30 minutes, and then gradually decreases in intensity so you won’t be awakened when it stops.
To learn more about the counterstimulation provided by Relaxis, click on the link here.
How to Use Relaxis
Relaxis is easy to use. Simply plug the device into a standard home outlet (near your bed is best). Then, place the device under the area of greatest discomfort while you are lying on your bed. Next, press the start button and adjust the intensity of vibration so it is comfortable for you and disrupts your RLS sensations. Lay back, relax, and fall asleep. Relaxis will run for 30 minutes, then ramp down for 5 minutes and shut itself off so it won’t wake you once you’ve fallen asleep. If necessary, it can be turned on for another cycle. For more complete instructions, refer to your “Instructions for Use” manual included with the device.
What are the alternatives to using the Relaxis device?
There are other alternatives to treat the symptoms of RLS. Ask your doctor what treatment may be best for you.
INDICATIONS FOR USE:
The purpose of Relaxis is to improve the quality of sleep in patients with primary Restless Legs Syndrome (RLS) through the use of vibratory counterstimulation.
This device should not be used by patients who have been diagnosed with deep venous thrombosis (DVT) in either leg during the last 6 months because of the known potential to dislodge or break up the clot.
For prescription use only.
WARNINGS & CAUTIONS:
- Relaxis is only intended for use by patients with primary Restless Legs Syndrome (RLS). It is not intended for use by people who have:
- Leg skin disorders such as eczema, psoriasis, cellulitis, non-healing wounds; or
- Secondary RLS.
- Contact your doctor if you have secondary RLS caused by iron deficiency anemia, back pain, kidney failure, diabetes, peripheral neuropathy (numbness or tingling in hands or feet), or pregnancy.
- Relaxis has not been tested on people who take drugs that may cause RLS or RLS symptoms. Safety and effectiveness have not been established in these people.
- You should be physically able to remove Relaxis if necessary.
- Only apply Relaxis to normal, intact, clean, healthy skin.
- The Relaxis pad and controller will become warmer during use. Stop use of Relaxis if the heat causes discomfort or pain.
- Relaxis consists of cotton (outer pad cover), polyvinyl chloride (inner pad cover), polyurethane foam (internal pad), acrylonitrile butadiene styrene and polyester plastic (controller). People with known allergic reactions to these materials should not use Relaxis. If a skin reaction occurs after you use Relaxis, contact your doctor.
- Stop using Relaxis and contact your doctor if your RLS symptoms worsen.
- Do not initiate more than two back-to-back 35-minute therapy cycles.
- Only apply Relaxis as needed. Too much stimulation may lead to discomfort.
- Do not use Relaxis in moist, wet, or dusty areas. This may increase the risk of electrical shock and failure.
- Do not use your Relaxis in oxygen rich areas.