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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2013 by Walter Reed National Military Medical Center
Sponsor:
Information provided by (Responsible Party):
Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier:
NCT01861652
First received: May 21, 2013
Last updated: May 22, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Restless Legs Syndrome,
Restless Legs,
Ekbom Syndrome
Device: Venous Health Systems Vasculaire Leg Compression Device

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Walter Reed National Military Medical Center:

Primary Outcome Measures:
  • 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)


Estimated Enrollment: 40
Study Start Date: July 2013
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals who are at least 18 years of age with a reliable diagnosis of RLS in accordance with the International Classification of Sleep Disorder, Revised Diagnostic and Coding Manual of the American Academy of Sleep Medicine. All patients included must have persistent symptoms that interfere with quality of life. Patients who are currently on approved medical therapy for RLS must be on a stable dose/agent for ≥30 days and experience persistent symptoms that interfere with quality of life. Patients who are currently refractory to medical therapies may also be included if they are presently under the care of a physician and receiving medical therapy for RLS for ≥30 days without improvement and/or having experienced unacceptable side effects. Pregnancy status is not being assessed and is not relevant to device use.

Exclusion Criteria:

  • Younger than 18 years, unstable medical conditions that may interfere with the requirements of the study, e.g. diabetes mellitus, symptomatic asthma, congestive heart failure with nocturnal symptoms, and mental or physical limitation (including dementia) that would preclude data collection on questionnaires or wearing intermittent pneumatic compression devices. Other medical conditions that would serve as exclusion criteria are those where increased venous or lymphatic return is undesirable. These specific conditions are known or suspected deep vein thrombosis, thrombophlebitis, severe congestive heart failure, pulmonary edema, severe arteriosclerosis, action infection such as gangrene, recent vein ligation or skin graft, or extreme deformity of the legs. Patients with iron deficiency anemia, or evidence of inadequate serum iron stores on laboratory testing are also excluded until this has been corrected.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01861652

Contacts
Contact: Jacob F Collen, MD 301-295-4547 ext 3, 1 jacob.collen@us.army.mil
Contact: Christopher J Lettieri, MD 301-295-4547 ext 3, 1 christopher.lettieri@us.army.mil

Locations
United States, Maryland
Walter Reed National Military Medical Center Not yet recruiting
Bethesda, Maryland, United States, 20889
Contact: Jacob F Collen, MD    301-295-4547 ext 3,1    jacob.collen@us.army.mil   
Contact: Christopher J Lettieri, MD    301-295-4547 ext 3, 1    christopher.lettieri@us.army.mil   
Sponsors and Collaborators
Walter Reed National Military Medical Center
Investigators
Principal Investigator: Jacob F Collen, MD Pulmonary, Critical Care, Sleep Medicine
Study Director: Christopher J Lettieri, MD Pulmonary, Critical Care, Sleep Medicine
  More Information

Publications:
Responsible Party: Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier: NCT01861652     History of Changes
Other Study ID Numbers: 388140
Study First Received: May 21, 2013
Last Updated: May 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Walter Reed National Military Medical Center:
Restless legs syndrome, Ekbom syndrome, Restless legs

Additional relevant MeSH terms:
Psychomotor Agitation
Restless Legs Syndrome
Syndrome
Disease
Dyskinesias
Dyssomnias
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Parasomnias
Pathologic Processes
Psychomotor Disorders
Signs and Symptoms
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on October 20, 2014