- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01861652
Vasculaire Leg Compression Device for the Treatment of Restless Legs Syndrome - A Prospective Clinical Study
The Use of the Vasculaire Leg Compression Device for the Treatment of Restless Legs Syndrome - A Prospective Clinical Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20889
- Walter Reed National Military Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Venous health systems Vasculaire leg compression device
Vasculaire leg compression device
|
Leg (calf) compression device used to alleviate symptoms of restless legs
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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))
|
one month
|
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.
|
one 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.
|
one month
|
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
|
one month
|
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)
|
1, 2, 3, 4 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jacob F Collen, MD, Pulmonary, Critical Care, Sleep Medicine
- Study Director: Christopher J Lettieri, MD, Pulmonary, Critical Care, Sleep Medicine
Publications and helpful links
General Publications
- Lettieri CJ, Eliasson AH. Pneumatic compression devices are an effective therapy for restless legs syndrome: a prospective, randomized, double-blinded, sham-controlled trial. Chest. 2009 Jan;135(1):74-80. doi: 10.1378/chest.08-1665. Epub 2008 Nov 18.
- Eliasson AH, Lettieri CJ. Sequential compression devices for treatment of restless legs syndrome. Medicine (Baltimore). 2007 Nov;86(6):317-323. doi: 10.1097/MD.0b013e31815b1319.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 388140
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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