REST Study (CompRESsion Therapy for RLS)

Radial Medical

Status: Terminated

Conditions: Restless Legs Syndrome

Treatments: Device: Cirvo(TM) therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT03852771

CL-00383

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Treatment

Experimental group

Description:

All participants will receive the intervention

Treatment:

Device: Cirvo(TM) therapy