Back to resultsREST Study (CompRESsion Therapy for RLS) (REST)
Primary Purpose
Restless Legs Syndrome
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cirvo(TM) therapy
Sponsored by
About this trial
This is an interventional treatment trial for Restless Legs Syndrome
Eligibility Criteria
Inclusion Criteria:
- Male or female over the age of 18.
- Diagnosis of Restless Leg Syndrome (RLS) per the Hopkins-Hening Diagnostic Questionnaire
- International RLS Study Group (IRLSS) Score ≥15.
- RLS symptoms occurring on at least 5 nights each week, with symptoms stable for at least 3 months.
Exclusion Criteria:
- Known or suspected deep vein thrombosis.
- Pregnancy
- Prior use with home intermittent pneumatic compression (IPC) device
- Currently using any other device to treat RLS
- Active skin infections in the affected leg
- Vein ligation or skin graft of the leg within past 12 months
- Mental or physical limitations that would prevent the subject from reliably completing study questionnaires.
- Physical impairments that would prevent the use of the CirvoTM device.
- Use of any medications typically used to treat RLS, where dose has not been stable for at least 2 months.
- 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
- History of pulmonary vascular disease (PVD)
- History of pulmonary edema
- History of decompensated congestive heart failure (CHF)
- Open surgery or major trauma to the legs within the last six months
- History of lower limb malignancy, primary or secondary
- Acute symptomatic lower extremity thrombophlebitis
- Any chronic back pain or lower extremity pain
- Other sleep problems that are felt to be currently affecting the quality of sleep
- Calf geometry on which Cirvo™ device does not appropriately fit
- Known sensitivity to any of the materials used in the Cirvo™ device
- 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.
Sites / Locations
- California Center for Sleep Disorders
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
All participants will receive the intervention
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
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.
Full Information
NCT ID
NCT03852771
First Posted
February 21, 2019
Last Updated
February 6, 2020
Sponsor
Radial Medical, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03852771
Brief Title
REST Study (CompRESsion Therapy for RLS)
Acronym
REST
Official Title
CompRESsion Therapy for Restless Leg Syndrome: An Evaluation of Cirvo™ for the Treatment of Restless Leg Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Company closure
Study Start Date
March 12, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radial Medical, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restless Legs Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
All participants will receive the intervention
Intervention Type
Device
Intervention Name(s)
Cirvo(TM) therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
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).
Description
Assessment of change in IRLSS scores from Baseline study visit to 56 days.
Time Frame
56 days
Secondary Outcome Measure Information:
Title
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.
Description
Change in disease severity as assessed by CGI-I scale
Time Frame
56 days
Title
Change in sleep quality between the Baseline study visit and the 56-day visit, as assessed by the Medical Outcomes Study (MOS) sleep scale.
Description
Change in sleep quality as assessed by MOS sleep scale from Baseline to 56 days
Time Frame
56 days
Title
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.
Description
Assessment of IRLSS score after each week of programmed therapy for first 4 weeks of therapy.
Time Frame
28 days
Other Pre-specified Outcome Measures:
Title
Therapy related adverse events
Description
Assessment of adverse events
Time Frame
56days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female over the age of 18.
Diagnosis of Restless Leg Syndrome (RLS) per the Hopkins-Hening Diagnostic Questionnaire
International RLS Study Group (IRLSS) Score ≥15.
RLS symptoms occurring on at least 5 nights each week, with symptoms stable for at least 3 months.
Exclusion Criteria:
Known or suspected deep vein thrombosis.
Pregnancy
Prior use with home intermittent pneumatic compression (IPC) device
Currently using any other device to treat RLS
Active skin infections in the affected leg
Vein ligation or skin graft of the leg within past 12 months
Mental or physical limitations that would prevent the subject from reliably completing study questionnaires.
Physical impairments that would prevent the use of the CirvoTM device.
Use of any medications typically used to treat RLS, where dose has not been stable for at least 2 months.
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
History of pulmonary vascular disease (PVD)
History of pulmonary edema
History of decompensated congestive heart failure (CHF)
Open surgery or major trauma to the legs within the last six months
History of lower limb malignancy, primary or secondary
Acute symptomatic lower extremity thrombophlebitis
Any chronic back pain or lower extremity pain
Other sleep problems that are felt to be currently affecting the quality of sleep
Calf geometry on which Cirvo™ device does not appropriately fit
Known sensitivity to any of the materials used in the Cirvo™ device
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.
Facility Information:
Facility Name
California Center for Sleep Disorders
City
Alameda
State/Province
California
ZIP/Postal Code
94501
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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REST Study (CompRESsion Therapy for RLS)
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