REST Study (CompRESsion Therapy for RLS) (REST)

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

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.

Study Overview

• Status: Terminated
• Conditions: Restless Legs Syndrome
• Intervention / Treatment: Device: Cirvo(TM) therapy

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Alameda, California, United States, 94501
      • California Center for Sleep Disorders

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; All participants will receive the 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapy related adverse events	Assessment of adverse events	56days

Collaborators and Investigators

• Sponsor: Radial Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2019
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: February 21, 2019
• First Submitted That Met QC Criteria: February 21, 2019
• First Posted (Actual): February 25, 2019

Study Record Updates

• Last Update Posted (Actual): February 10, 2020
• Last Update Submitted That Met QC Criteria: February 6, 2020
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Dyskinesias; Psychomotor Disorders; Parasomnias; Syndrome; Psychomotor Agitation; Restless Legs Syndrome
• Other Study ID Numbers: CL-00383

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No