REST Study (CompRESsion Therapy for RLS)

NCT ID: NCT03852771

Last Updated: 2020-02-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-12
• Study Completion Date: 2020-01-31

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.

Conditions

Restless Legs Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

All participants will receive the intervention

Group Type: EXPERIMENTAL

Cirvo(TM) therapy

Intervention Type: DEVICE

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.

Interventions

Cirvo(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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radial Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

California Center for Sleep Disorders

Alameda, California, United States

Countries

United States

Other Identifiers

CL-00383

Identifier Type: -

Identifier Source: org_study_id