REST Study (CompRESsion Therapy for RLS)

NCT03852771 | Terminated FDA Device

• 1 other identifier: CL-00383
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

  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.

  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.

  28 days

Other Outcomes (1)

• Therapy related adverse events

  56days

Study Arms (1)

Treatment

EXPERIMENTAL

All participants will receive the intervention

Device: Cirvo(TM) therapy

Interventions

Cirvo(TM) therapy 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.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Radial Medical, Inc.: lead

Study Sites (1)

California Center for Sleep Disorders

Alameda, California, 94501, United States

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: February 25, 2019
• Study Start: March 12, 2019
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: February 10, 2020

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)