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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 2-week baseline (no intervention) followed by 8-weeks of investigational medical device intervention (weeks 3-10) followed by 2-weeks with no intervention (weeks 11-12).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Device Protocol | Experimental | Participants will use the investigational noninvasive neuromodulation device as instructed over a period of 8 weeks (weeks 3 through 10). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Noninvasive Neuromodulation Device | Device | The investigational noninvasive neuromodulation device will be setup by the patient at bedtime and will be used every night. The IRB has established that the investigational device is non-significant risk. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in IRLS Rating Scale 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 from study entry to Week 10. | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in the number of nights with RLS per week | This outcome measures the change in subject-reported number of nights with RLS, which ranges from 0 to 7 for each time point assessed. The mean change is assessed from study entry to Week 10. A greater decrease represents a better outcome. | 10 weeks |
| Mean Change in MOS-II |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan D Charlesworth, PhD | Noctrix Health, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Noctrix Health Headquarters | Pleasanton | California | 94566 | United States |
Due to the investigational nature of the device, IPD will not be shared for this study.
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| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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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 from study entry to Week 10. |
| 10 weeks |
| Mean Change in MOS-I | 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 from study entry to Week 10. | 10 weeks |
| Mean PGI-I score | The Patient Global Impressions of Improvement (PGI-I) score assesses the patient's perception of their condition's improvement from study entry, with scores ranging from: Very Much Improved (1), Much Improved (2), Minimally Improved (3), No Change (4), Minimally Worse (5), Much Worse (6), Very Much Worse (7). The mean is assessed at Week 10 relative to study entry. | 10 weeks |
| Percent of Patients Reporting Much Improved or Very Much Improved | 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). This endpoint assesses the responder rate at Week 10. | 10 weeks |
| Mean Change in Periodic Limb Movement Index (PLMI) | Mean change in the total number of periodic limb movements (PLMs) per hour of sleep from Weeks 1-2 to Weeks 9-10. A greater decrease in PLMs per hour corresponds to a better outcome. | 10 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%. This endpoint measures the mean change from Weeks 1-2 to Weeks 9-10. | 10 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. This endpoint measures the mean change from Weeks 1-2 to Weeks 9-10. | 10 weeks |
| Mean Change in Total Sleep Time (TST) | Total sleep times (TST) refers to the total minutes of sleep starting at bedtime until waking up in the next morning. Higher TST corresponds to a better outcome. This endpoint measures the mean change from Weeks 1-2 to Weeks 9-10. | 10 weeks |
| D020447 |
| Parasomnias |
| D001523 | Mental Disorders |