REST Study (CompRESsion Therapy for RLS)

Restless Legs Syndrome Clinical Trial

— REST  

Official title:

CompRESsion Therapy for Restless Leg Syndrome: An Evaluation of Cirvo™ for the Treatment of Restless Leg Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03852771
• Other study ID #: CL-00383
• Status: Terminated
• Phase: N/A
• Start date: March 12, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: March 2019
• Source: Radial Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	California Center for Sleep Disorders	Alameda	California

Sponsors (1)

Lead Sponsor	Collaborator
Radial Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Therapy related adverse events	Assessment of adverse events	56days
Primary	Change in disease severity between the Baseline study visit and the 56-day visit, as assessed by the International Restless Leg Syndrome Study Group Severity Scale (IRLSS).	Assessment of change in IRLSS scores from Baseline study visit to 56 days.	56 days
Secondary	Change in disease severity between the Baseline study visit and the 56-day visit, as assessed by the Clinical Global Impression (CGI-I) rating scale.	Change in disease severity as assessed by CGI-I scale	56 days
Secondary	Change in sleep quality between the Baseline study visit and the 56-day visit, as assessed by the Medical Outcomes Study (MOS) sleep scale.	Change in sleep quality as assessed by MOS sleep scale from Baseline to 56 days	56 days
Secondary	Change in disease severity between the Baseline study visit and after the last usage of the each parameter set trialed in Period 1 (nominally days 7, 14, 21, and 28), as assessed by the IRLSS.	Assessment of IRLSS score after each week of programmed therapy for first 4 weeks of therapy.	28 days