Looking for an alternative treatment to opioid medications for RLS?

You may be eligible to participate in a clinical study to reduce or replace your opioid dosage with a wearable device.

I'm Interested
Study overview

This study evaluates reducing or replacing your opioid dosage for RLS by using a wearable device (device that you put on your legs) to manage your RLS symptoms.

Your opioid dosage will be reduced slowly over time, and you will be under the care of a clinician experienced in managing and prescribing opioids for RLS patients.

If this wearable device is found to be safe and effective, it may be made widely available to people with RLS, like you.

The 4-6-week study evaluates how well the study device may relieve RLS symptoms while reducing your opioid dosage.

The investigational study device could help you see the following types of relief while reducing or replacing your opioid dosage:

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 opioid medication(s) for RLS
Common opioids include the following: methadone, oxycodone (i.e. Percocet®, OxyContin®), buprenorphine (i.e. Suboxone®), or hydrocodone (i.e. Vicodin®)
You are between the ages of 22 and 89
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).

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 can become less effective over time.
Currently, there are few medical devices available to treat RLS and the leading medications can have long-term risks. Therefore, there is a need for more treatment options.
By enrolling in this new trial:
you could contribute to the development of a new therapy for RLS.
You could potentially see the following types of relief while reducing or replacing your opioid dosage:
reduced discomfort in the legs and feet
reduced urge to move the legs and feet
help with falling and staying asleep
You will be evaluated by experienced study clinicians specializing in RLS treatment, and your participation in this 4-6-week study will help lead to a better understanding of the effectiveness of the study wearable device.
I'm Interested

What is the purpose of this clinical trial?

The purpose of this study is to determine if the investigational wearable device therapy can be effective and safe when used as part of a treatment plan with reduced dosage of opioid medications for RLS.

What's involved?

In this 4–6 week clinical trial, you will test a wearable device treatment option for managing the symptoms of RLS.

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 4-6 week study duration, you will:

use wearable study device at home on each night that you experience RLS symptoms
slowly reduce your opioid dosage and keep other medications constant while under the care of an experienced clinician
complete a mix of in-person and virtual visits
complete a daily eDiary to record your experiences and symptoms.

What is the treatment?

The treatment in this study is a wearable medical device.  The study device is worn on both legs, just below your knees.
Previous studies suggest that each use of the study device may result in rapid reduction of RLS symptoms, reducing discomfort in the legs and feet and reducing the urge to move the legs and feet.
Along with the study device, you will take a reduced dose of your current opioid medication while under the care of an experienced clinical who specializes in RLS treatment.

What are the downsides of long-term opioid usage?

Opioid medications for RLS, such as methadone, oxycodone (i.e. Percocet®, OxyContin®), buprenorphine (i.e. Suboxone®), or hydrocodone (i.e. Vicodin®) have potential long-term drawbacks such as:

Risk of dependency
Risk of addiction

Long term use of opioids can change brain chemistry and lead to drug tolerance, meaning that a higher dose of the opioid is needed to produce the same effect.

Long-term use of opioids causes changes to areas of the brain that control and regulate long-term memory, decision-making, social behaviors and thought processes.

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?

No, you will not receive a placebo.  All participants will receive active treatment for the entire duration of the study.

Where is the study conducted?

There is 1 site 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 4-6 weeks

What about my current medications?

• You will take a lower dosage of your opioid RLS medications throughout the study.

• If you’re currently taking other medication(s), you will be able to continue taking them 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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