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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
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.
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.
Noctrix Health Headquarters
Pleasanton, California, United States
RECRUITINGNumber 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
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
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
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
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.
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Time frame: 12 weeks
Mean change in Medical Outcomes Study Sleep Problems Index II (MOS-II) score
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.
Time frame: 12 weeks
Patient Global Impressions - Improvement (PGI-I) responder rate
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.
Time frame: 12 weeks