Can I participate?

You may be eligible for this study if:

You are between the ages of 22 and 89

Your current RLS symptoms are moderate or severe

Common symptoms include discomfort in the legs and feet, urge to move the legs and feet, and difficulty falling and staying asleep. Symptoms tend to get worse at night.

Your RLS is not the result of another medical condition

You are not pregnant or trying to become pregnant

You have never taken medication for your RLS

**This is not a complete list and other eligibility criteria may apply

I'm Interested

Why should I participate?

Your participation may contribute to the development of a new therapy for Restless Legs Syndrome (RLS) based on a wearable medical device instead of a pill.

Restless Legs Syndrome (RLS) is a neurological condition that disrupts sleep quality and can dramatically reduce quality of life. There is no known cure for RLS, symptoms tend to worsen with age, and some existing medications for RLS become less effective over time.

By enrolling in this trial:

You could potentially experience a reduction in your RLS symptoms such as:

reduced discomfort in the legs and feet

reduced urge to move the legs and feet

less difficulty falling and staying asleep

You could contribute to the development of a new therapy for RLS

You will be evaluated by study doctors specializing in RLS and your participation in this 6-week study will help lead to a better understanding of the effectiveness of the study treatment.

I'm Interested

What is the purpose of this clinical trial?

The purpose of this study is to evaluate the potential benefits of a wearable device for individuals with RLS, including its effects on reducing RLS symptoms and improving sleep quality. If you were recently diagnosed with RLS, this may be a good study for you!

What's involved?

In this 6-week clinical trial, you will test an investigational treatment option for managing the symptoms of RLS based on a wearable study device instead of a medication.

Step 1

Application

Click here to see if you may be eligible for this study.

Step 2

Pre-screening phone call

If you may be eligible, a patient outreach representative will call you, provide additional details about the study, and further evaluate your eligibility.

Step 3

Screening

The study team will determine if you are eligible to participate in the study; if you qualify and decide to participate, you will be enrolled in the study.

Step 4

Study

During the 6-week study duration, you will:

use a wearable study device at home on nights that you experience RLS symptoms

complete a mix of in-person and virtual visits (at least 3 in-person visits)

In-person visits occur on weeks 0, 2, and 4

complete a daily eDiary to record your experiences and symptoms

Frequently asked questions

How do I get started?

Click “I'm Interested” and enter your information to express interest in the study.

Why didn’t I qualify?

Research studies are designed in specific ways to test the study drug or safety and effectiveness. One or more of the answers that you provided were outside of the guidelines for this trial. This does not mean you will not qualify for different research studies.

Is there a chance I will receive a placebo?

Everyone will receive active study treatment for a 2-week period. Some may also receive placebo study treatment for a separate 2-week period.

Where is the study conducted?

There are 2 sites located in the USA.

How do I use the study device?

At the beginning of the study, you will receive training on how to use the study device at home. You will also receive follow-up instructions and training throughout the study.

How does the study device work?

The study device delivers low-intensity stimulation to the nerves of the legs. It is worn on both legs just below the knees.

Has the study device been tested before?

The study device has been tested in previous clinical studies. Previous studies suggest that each use of the study device may result in rapid reduction of RLS symptoms, such as reducing discomfort in the legs and feet and reducing the urge to move the legs and feet.

Will I receive compensation?

You will receive a fixed amount of compensation for your time and travel.

Can I leave the study at any time?

Yes, you can leave the study at any time.

What is the duration of the study?

The study will last approximately 6 weeks.

What about my current medications?

If you’re currently taking medication, you will be able to continue taking it during the study.

Can I keep the study devices after the study is over?

No, you will need to return the study devices after the study.

Are you looking for a potential new therapy for your RLS?

This study evaluates an investigational treatment option for Restless Legs Syndrome (RLS) based on a wearable device therapy (device that you put on your legs)

The 6-week study evaluates how well the study device may reduce RLS symptoms. You could potentially see the following types of relief: