Health TrialsbyHealthPanel

Optimizing Extended-Duration (XD-) TOMAC Therapy for Restless Legs Syndrome (RLS)

ConditionRestless Legs Syndrome (RLS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorNoctrix Health, Inc.

About this trial

This study assesses the tolerability, safety, and impact of an investigational medical device on restless legs syndrome symptoms.

The IRB has established that the investigational device is non-significant risk.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject has signed a valid, IRB-approved informed consent form, can understand the requirements of the study and instructions for device usage, and can converse in English

Subject has received a medical diagnosis of primary restless legs syndrome (RLS).

Subject agrees to not change dosage or schedule of any medications that are known to impact RLS symptoms during the study, including RLS medications, antidepressants, sleep medications, or sedative antihistamines or treatments such as CPAP (continuous positive airway pressure).

Subject reports that RLS symptoms are most significant in lower legs and/or feet.

Disqualifiers

The subject has an active medical device implant anywhere in the body (including but not limited to pacemakers, spinal cord stimulators, deep brain stimulators).

The subject has a metal implant at the site of the study device electrode application (not including knee replacements).

The subject has been diagnosed with epilepsy or other seizure disorder.

The subject has a moderate or severe cognitive disorder or mental illness that would affect his or her ability to participate in the study.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Investigational Extended Duration (XD-) TOMAC Therapy

    Device

    The investigational noninvasive neuromodulation device will be setup by the participant at bedtime and used to provide Extended Duration Tonic Motor Activation (XD-TOMAC) every night. The IRB has established that the investigational device is non-significant risk.

  • Tonic Motor Activation (TOMAC) Therapy

    Device

    The noninvasive neuromodulation device will be setup by the participant to be used for TOMAC 30-minute stimulation therapy sessions as needed during the 2nd week of the study and as appropriate for the remainder of the study. The IRB has established that the device is non-significant risk.

Treatment groups

20 Participants
are divided into 3 treatment groups
Group A: Investigational XD-TOMAC Therapy 1Experimental treatment 2 interventions
Group B: Investigational XD-TOMAC Therapy 2Experimental treatment 2 interventions
Group C: Investigational XD-TOMAC Therapy 3Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of RLS-related awakenings per night

This outcome measures the number of awakenings per night that were related to RLS symptoms. A lower number represents a better outcome. Assessed via daily sleep diary and compared for each intervention to the Baseline period

Time frame
12 weeks

Secondary outcomes

1

Mean change in International RLS Study Group Rating Scale (IRLS) total score

International Restless Legs Syndrome Study Group (IRLS) Rating Scale Score is a participant-rated questionnaire that rates RLS severity from 0-40, where 40 is the most severe. The mean change is assessed over the final week of each intervention and compared to assessment at Study Entry.

Time frame
12 weeks
2

Mean change in sleep efficiency percentage

Sleep efficiency (SE) is the percentage of the time a person spends asleep relative to the total time dedicated to sleep. A better outcome corresponds to a percentage closer to 100%. Assessed via daily sleep diary and compared from the last week of each intervention to the Baseline period.

Time frame
12 weeks
3

Mean change in minutes awake after sleep onset (WASO)

Minutes Awake after Sleep Onset (WASO) refer to the total number of minutes awake after first going to sleep and before waking up for the next day in the morning. Lower WASO corresponds to a better outcome. Assessed via daily sleep diary and compared from the last week of each intervention to the Baseline period.

Time frame
12 weeks
4

Mean change in minutes awake after sleep onset with RLS symptoms (WASO-R)

Minutes Awake after Sleep Onset (WASO-R) refer to the total number of minutes awake with RLS symptoms after first going to sleep and before waking up for the next day in the morning. Lower WASO-R corresponds to a better outcome. Assessed via daily sleep diary and compared from the last week of each intervention to the Baseline period.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Noctrix Health, Inc.

Lead sponsor

Source ClinicalTrials.gov
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