Status:
TERMINATED
REST Study (CompRESsion Therapy for RLS)
Lead Sponsor:
Radial Medical, Inc.
Conditions:
Restless Legs Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- Male or female over the age of 18.
- Diagnosis of Restless Leg Syndrome (RLS) per the Hopkins-Hening Diagnostic Questionnaire
- International RLS Study Group (IRLSS) Score ≥15.
- RLS symptoms occurring on at least 5 nights each week, with symptoms stable for at least 3 months.
Exclusion
- Known or suspected deep vein thrombosis.
- Pregnancy
- Prior use with home intermittent pneumatic compression (IPC) device
- Currently using any other device to treat RLS
- Active skin infections in the affected leg
- Vein ligation or skin graft of the leg within past 12 months
- Mental or physical limitations that would prevent the subject from reliably completing study questionnaires.
- Physical impairments that would prevent the use of the CirvoTM device.
- Use of any medications typically used to treat RLS, where dose has not been stable for at least 2 months.
- 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
- History of pulmonary vascular disease (PVD)
- History of pulmonary edema
- History of decompensated congestive heart failure (CHF)
- Open surgery or major trauma to the legs within the last six months
- History of lower limb malignancy, primary or secondary
- Acute symptomatic lower extremity thrombophlebitis
- Any chronic back pain or lower extremity pain
- Other sleep problems that are felt to be currently affecting the quality of sleep
- Calf geometry on which Cirvo™ device does not appropriately fit
- Known sensitivity to any of the materials used in the Cirvo™ device
- 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.
Key Trial Info
Start Date :
March 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2020
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03852771
Start Date
March 12 2019
End Date
January 31 2020
Last Update
February 10 2020
Active Locations (1)
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1
California Center for Sleep Disorders
Alameda, California, United States, 94501