Are you suffering from Restless Legs Syndrome?

You may be eligible to participate in a clinical study for an investigational treatment option.

I'm Interested
Study overview

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

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

The 8-week study evaluates how well the study device may reduce RLS symptoms. You could potentially see the following types of relief:

reduced discomfort in the legs and feet
reduced urge to move the legs and feet
help with falling and staying asleep

Can I participate?

You may be eligible for the RESTFUL study if:

You are currently taking or have taken prescription medication(s) for RLS in the past
Your RLS medication does not fully treat your RLS symptoms
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 between the ages of 22 and 79
You are not pregnant or trying to become pregnant

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

I'm Interested

What you may receive

Study-related treatment at no cost
Fixed amount of compensation for your time and travel
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 new 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 8-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 determine the effectiveness and safety of a wearable device for RLS symptoms in adults who have not responded fully to RLS medication(s).

What's involved?

In this 8-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

Throughout the 8-week study duration, you will:

use wearable study device at home on each night that you experience RLS symptoms.
complete a mix of in-person and virtual visits, including 4 in-person visits
In-person visits occur on weeks 0, 2, 4, and 8
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?

You will be assigned active study treatment for at least 4-weeks. There is a 50% chance you will be assigned active study treatment for all 8-weeks and a 50% chance you will be assigned active study treatment for 4-weeks and placebo study treatment for 4-weeks.

Where is the study conducted?

There are 4 sites 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 8 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.

About the sponsor

Noctrix Health was founded by a team of neuroscientists and neural engineers to pioneer the next-generation of therapeutic wearables.  We aim to empower RLS patients to take control of their symptoms by providing an effective and cost-effective alternative to pharmaceutical treatments.  Our partners include world-leading clinicians in the treatment of Restless Legs Syndrome.  Noctrix Health is based in the San Francisco Bay Area.

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