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Vasculaire Leg Compression Device for the Treatment of Restless Legs Syndrome - A Prospective Clinical Study

NCT01861652 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-06-16

No results posted yet for this study

Summary

Restless legs syndrome (RLS) is a debilitating sleep disorder that has significant impact on quality of life, and often times can be difficult to diagnose and treat effectively. RLS is typically treated with medical therapy (including dopaminergic agents, dopamine agonists, benzodiazepines, anticonvulsants, opiates, among other therapies). Many patients are either refractory to medical therapy, have contraindications or adverse reactions to the available medical therapies, or desire conservative non-medication based therapies. Two previous studies have demonstrated that pneumatic compression devices placed on the legs can improve symptoms of RLS. We would like to assess whether the Venous Health Systems Vasculaire leg compression device improves symptoms and quality of life measures related to RLS in up to 40 patients evaluated prospectively for one month. This is a pilot study to assess the subjective response of our cohort of patients to this device prospectively. Our hypothesis is that over 66% of our cohort will demonstrate a positive symptomatic response based on RLS specific quality of life questionnaires.

Conditions

  • Restless Legs Syndrome,
  • Restless Legs,
  • Ekbom Syndrome

Interventions

DEVICE

Venous Health Systems Vasculaire Leg Compression Device

Leg (calf) compression device used to alleviate symptoms of restless legs

Sponsors & Collaborators

  • Walter Reed National Military Medical Center

    lead FED

Principal Investigators

  • Jacob F Collen, MD · Pulmonary, Critical Care, Sleep Medicine

  • Christopher J Lettieri, MD · Pulmonary, Critical Care, Sleep Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-01-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01861652 on ClinicalTrials.gov