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This study in patients with restless leg syndrome (RLS) will evaluate the use of Cirvoâ„¢ therapy for the treatment of this disorder when applied to both legs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | All participants will receive the intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cirvo(TM) therapy | Device | The Cirvo(TM) (also referred to as the Radial Medical Compression System) is a mobile wearable medical device that applies graded intermittent mechanical sequential compression to the lower leg. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in disease severity between the Baseline study visit and the 56-day visit, as assessed by the International Restless Leg Syndrome Study Group Severity Scale (IRLSS). | Assessment of change in IRLSS scores from Baseline study visit to 56 days. | 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in disease severity between the Baseline study visit and the 56-day visit, as assessed by the Clinical Global Impression (CGI-I) rating scale. | Change in disease severity as assessed by CGI-I scale | 56 days |
| Change in sleep quality between the Baseline study visit and the 56-day visit, as assessed by the Medical Outcomes Study (MOS) sleep scale. |
| Measure | Description | Time Frame |
|---|---|---|
| Therapy related adverse events | Assessment of adverse events | 56days |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Center for Sleep Disorders | Alameda | California | 94501 | United States |
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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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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Change in sleep quality as assessed by MOS sleep scale from Baseline to 56 days |
| 56 days |
| Change in disease severity between the Baseline study visit and after the last usage of the each parameter set trialed in Period 1 (nominally days 7, 14, 21, and 28), as assessed by the IRLSS. | Assessment of IRLSS score after each week of programmed therapy for first 4 weeks of therapy. | 28 days |
| D020447 |
| Parasomnias |
| D001523 | Mental Disorders |