Vasculaire Leg Compression Device for the Treatment of Restless Legs Syndrome - A Prospective Clinical Study
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.
Restless Legs Syndrome,
Device: Venous Health Systems Vasculaire Leg Compression Device
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Use of the Vasculaire Leg Compression Device for the Treatment of Restless Legs Syndrome - A Prospective Clinical Study|
- The Restless Legs Syndrome Rating Scale [ Time Frame: one month ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]assesses a patient's symptoms of RLS over the preceding week in terms of severity (numeric score)
|Study Start Date:||July 2013|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Experimental: Venous health systems Vasculaire leg compression device
Vasculaire leg compression device
Device: Venous Health Systems Vasculaire Leg Compression Device
Leg (calf) compression device used to alleviate symptoms of restless legs
Other Name: intermittent pneumatic compression device; sequential intermittent pneumatic compression device
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.
We are performing a Prospective cohort study.
We will recruit patients until we reach an N=40.
After informed consent, the patient's record will be reviewed to ensure that they have had a serum iron panel and ferritin checked within the preceding 6 months. For those patients missing these laboratory studies, they will have their blood drawn for a full serum iron panel (serum iron level, serum ferritin, and total iron binding capacity), as per standard of care (to exclude iron deficiency as a cause or contributor to their symptoms). Patients with inadequate serum iron stores will be excluded. Patients with adequate iron stores will be asked to complete a comprehensive medical questionnaire to document medical conditions and medications with doses prescribed.
This questionnaire will also record previously tried therapies, both home remedies and medically prescribed treatments. Specific undesirable side effects will also be documented.
Severity will then be determined based on 5 previously validated questionnaire instruments (The Restless Legs Syndrome Rating Scale, The Restless Legs Syndrome-Quality of Life Instrument (RLS-QLI), The Epworth Sleepiness Scale (ESS), The Johns Hopkins Restless Legs Severity Scale (JHRLS), The International Restless Legs Syndrome Rating Scale).
Once the medical history has been reviewed, documentation of severity assessed and the determination of unresolved treatment post medical therapy, the patient will be eligible for enrollment.
The Vasculaire Intermittent Pneumatic Compression System will be introduced to the patient and instructions provided on how to optimize the use of device in accordance with the study protocol.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01861652
|United States, Maryland|
|Walter Reed National Military Medical Center|
|Bethesda, Maryland, United States, 20889|
|Principal Investigator:||Jacob F Collen, MD||Pulmonary, Critical Care, Sleep Medicine|
|Study Director:||Christopher J Lettieri, MD||Pulmonary, Critical Care, Sleep Medicine|