Status:
WITHDRAWN
Vasculaire Leg Compression Device for the Treatment of Restless Legs Syndrome - A Prospective Clinical Study
Lead Sponsor:
Walter Reed National Military Medical Center
Conditions:
Restless Legs Syndrome,
Restless Legs,
Eligibility:
All Genders
18+ years
Phase:
NA
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 treat...
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 typic...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01861652
Start Date
July 1 2013
Last Update
June 16 2015
Active Locations (1)
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1
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889