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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: The Use of the Vasculaire Leg Compression Device for the Treatment of Restless Legs Syndrome - A Prospective Clinical Study

Brief 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.

Detailed Summary:

BACKGROUND:

Restless Leg Syndrome (RLS) affects nearly 12 million Americans. Although the precise etiology of RLS is not well characterized, there are specific diagnostic criteria. Symptoms are typically worse in the evening, consisting of a strong urge to move the affected limb(s) and relief with movement. Current medical therapies pose several challenges for many patients, as side effects include extreme drowsiness, hallucinations, nausea, headaches and insomnia. An alternative, non-medical therapy may provide a suitable option to this subset of patients. Intermittent pneumatic compression devices have previously been studied in this population, and have demonstrated effectiveness. However prior models have required subjects to remain immobile during use, representing a significant limitation given that immobility may actually promote worsening of symptoms. An effective, alternative non-pharmacologic therapy that does not interfere with patient mobility should provide a valuable treatment option.

The purpose of this study is to assess whether the Vasculaire Intermittent Pneumatic Compression System will improve validated measures of symptom relief, patient satisfaction, and quality of life for RLS. This is a pilot study to determine whether or not the Vasculaire device improves validated measures of symptom relief, patient satisfaction, and quality of life in RLS patients. Depending on the outcome of our study we hope to develop a sham-controlled clinical trial as a follow-up study.

METHODS:

We are performing a Prospective cohort study.

We will recruit patients until we reach an N=40.

After informed consent, the patient's re
Sponsor: Walter Reed National Military Medical Center

Current Primary Outcome:

  • The Restless Legs Syndrome Rating Scale [ Time Frame: one month ]
    the patient rates their symptoms of RLS on a severity scale (none (0), mild (1-10), moderate (11-20), severe (21-30), very severe (31-40))
  • The Restless Legs Syndrome-Quality of Life Instrument (RLS-QLI) [ Time Frame: one month ]
    18 questions assessing how RLS has affected patient's quality of life over the preceding month.
  • The Epworth Sleepiness Scale (ESS) [ Time Frame: one month ]
    A validated questionnaire for assessing daytime sleepiness; propensity to fall asleep during routine daily tasks/events.
  • The Johns Hopkins Restless Legs Severity Scale (JHRLS) [ Time Frame: one month ]
    assesses how severe a patient's RLS symptoms are at different points in the day (symptoms occuring earlier in the day is worse). Severity graded as 0=never, 0.5=infrequent, 1=mild, 2=moderate, 3=severe, 4=very severe
  • The International Restless Legs Syndrome Rating Scale [ Time Frame: 1, 2, 3, 4 weeks ]
    assesses a patient's symptoms of RLS over the preceding week in terms of severity (numeric score)


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Walter Reed National Military Medical Center

Dates:
Date Received: May 21, 2013
Date Started: July 2013
Date Completion:
Last Updated: June 12, 2015
Last Verified: May 2013