Restless Legs Syndrome
Conditions
Brief summary
This study in patients with restless leg syndrome (RLS) will evaluate the use of Cirvo™ therapy for the treatment of this disorder when applied to both legs.
Interventions
DEVICECirvo(TM) therapy
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.
Sponsors
Radial Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female over the age of 18. 2. Diagnosis of Restless Leg Syndrome (RLS) per the Hopkins-Hening Diagnostic Questionnaire 3. International RLS Study Group (IRLSS) Score ≥15. 4. RLS symptoms occurring on at least 5 nights each week, with symptoms stable for at least 3 months.
Exclusion criteria
1. Known or suspected deep vein thrombosis. 2. Pregnancy 3. Prior use with home intermittent pneumatic compression (IPC) device 4. Currently using any other device to treat RLS 5. Active skin infections in the affected leg 6. Vein ligation or skin graft of the leg within past 12 months 7. Mental or physical limitations that would prevent the subject from reliably completing study questionnaires. 8. Physical impairments that would prevent the use of the CirvoTM device. 9. Use of any medications typically used to treat RLS, where dose has not been stable for at least 2 months. 10. If previously on medication to treat RLS, patient must have been weened under medical supervision and off medication for at least 14 days at time of enrollment 11. History of pulmonary vascular disease (PVD) 12. History of pulmonary edema 13. History of decompensated congestive heart failure (CHF) 14. Open surgery or major trauma to the legs within the last six months 15. History of lower limb malignancy, primary or secondary 16. Acute symptomatic lower extremity thrombophlebitis 17. Any chronic back pain or lower extremity pain 18. Other sleep problems that are felt to be currently affecting the quality of sleep 19. Calf geometry on which Cirvo™ device does not appropriately fit 20. Known sensitivity to any of the materials used in the Cirvo™ device 21. Currently participating or plans to participate in in any other investigational clinical evaluation during the 56 day study period that may, in the opinion of the investigator, affect RLS.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 56 days | Assessment of change in IRLSS scores from Baseline study visit to 56 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 56 days | Change in disease severity as assessed by CGI-I scale |
| Change in sleep quality between the Baseline study visit and the 56-day visit, as assessed by the Medical Outcomes Study (MOS) sleep scale. | 56 days | Change in sleep quality as assessed by MOS sleep scale from Baseline to 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. | 28 days | Assessment of IRLSS score after each week of programmed therapy for first 4 weeks of therapy. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Therapy related adverse events | 56days | Assessment of adverse events |
Countries
United States
Outcome results
None listed