Restless Legs Syndrome (RLS)
Conditions
Keywords
TOMAC, stimulation, neuromodulation, RLS
Brief summary
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.
Detailed description
In this 12-week study, participants complete a 1-week baseline (no intervention) followed by 1-week Tonic Motor Activation (TOMAC) therapy (30-minutes of stimulation). Next, participants complete 4-weeks of Extended Duration (XD-) TOMAC. Then, participants will complete investigational TOMAC medical device interventions for 6-weeks in a pseudo-randomized order.
Interventions
DEVICEInvestigational Extended Duration (XD-) TOMAC Therapy
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.
DEVICETonic Motor Activation (TOMAC) Therapy
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.
Sponsors
Noctrix Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Participants will receive each of three interventions in the final phase of the study in a pseudo-randomized order.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * Subject reports that RLS symptoms caused awakenings or interfered with falling back asleep at least 3 nights per week during the month prior to study entry. * The subject possesses the necessary equipment, internet/phone accessibility, and communication ability to complete electronic questionnaires and respond to electronic communications and phone calls from the research staff throughout the in-home portion of the study. * Subject has moderate-severe RLS symptoms as defined by a score of 15 or greater points on IRLS (International Restless Legs Syndrome Study Group Rating Scale). * Subject is 21 years of age or older.
Exclusion criteria
* 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. * The subject has a known allergy to device materials, electrode gel, polyurethane foam, or lycra (or a severe previous reaction to medical adhesives or bandages). * Subject has any of the following at or near the location of device application: Acute injury, Cellulitis, Open sores * The subject is unable or unwilling to comply with study requirements. * The subject has a medical condition not listed above that may put them at risk. * Subject has prior experience with neurostimulation devices developed by the study sponsor * Subject has a primary sleep disorder other than RLS that significantly interferes with sleep at the present time (e.g. obstructive sleep apnea stably controlled via CPAP would not be an exclusion). * On nights with no RLS symptoms (if any), subject reports typical sleep onset latency of \>60min. * Subject has severe peripheral neuropathy affecting the lower legs and/or subject has neuropathy and is unable to clearly distinguish between symptoms of neuropathy and symptoms of RLS. * Subject reports a habitual sleep schedule that is not primarily aligned with nighttime hours (bedtime 8:00pm-2:00am and morning awakening 4:00am-11:00am), or reports that bedtime regularly varies by more than 4 hours (e.g., due to shift work or an inconsistent sleep schedule). * Subject is taking an unstable or inconsistent dose or schedule of medication that is likely to impact RLS symptoms or sleep, such as RLS medications, antidepressants, sleep medications, or sedative antihistamines. * Subject has changed dose or schedule of medication or treatment that is likely to impact RLS symptoms or sleep in the past 30 days, such as RLS medications, antidepressants, sleep medications, or sedative antihistamines or treatments such as CPAP. * During initial device set-up, device does not properly fit the subject or calibrated intensity settings are outside of operational range
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of RLS-related awakenings per night | 12 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in International RLS Study Group Rating Scale (IRLS) total score | 12 weeks | 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. |
| Mean change in sleep efficiency percentage | 12 weeks | 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. |
| Mean change in minutes awake after sleep onset (WASO) | 12 weeks | 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. |
| Mean change in minutes awake after sleep onset with RLS symptoms (WASO-R) | 12 weeks | 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. |
| Mean change in Medical Outcomes Study Sleep Problems Index II (MOS-II) score | 12 weeks | The Medical Outcomes Study Sleep Problems Index II (MOS-II) score is a subscale of the participant-rated MOS questionnaire that measures subjective sleep quality. The MOS-I (6-items) and MOS-II (9-items) are the two validated subscales of the 12-item MOS Sleep Scale. Both are scored from 0 to 100, where 100 corresponds to the worst possible sleep problems and 0 corresponds to no sleep problems. The mean change is assessed over the final 2-weeks of each intervention and compared to assessment at Study Entry. |
| Patient Global Impressions - Improvement (PGI-I) responder rate | 12 weeks | The Responder Rate is the percentage of subjects with a Patient Global Impressions of Improvement (PGI-I) rating of Much Improved or Very Much Improved relative to study entry. The scores for the Patient Global Impressions of Improvement (PGI-I) are: Very Much Improved (1), Much Improved (2), Minimally Improved (3), No Change (4), Minimally Worse (5), Much Worse (6), Very Much Worse (7). Assessed over the final week of each intervention. |
Countries
United States
Contacts
CONTACTClinical Research Coordinator
PRINCIPAL_INVESTIGATORJonathan D Charlesworth, PhD
Noctrix Health
Outcome results
None listed