REST Study (CompRESsion Therapy for RLS)

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.