REST Study (CompRESsion Therapy for RLS)

Stopped early · Not applicable

Conditions studied: Restless Legs Syndrome

In brief

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.

Key facts

Study ID

NCT03852771

Run by

Radial Medical, Inc.

People needed

18

Starts

2019-03-12

Expected to finish

2020-01-31

Last updated by the study team

2020-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• California Center for Sleep Disorders — Alameda, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.