Sequential Compression Devices for Treatment of Restless Legs Syndrome

Last updated: November 29, 2007
Sponsor: Walter Reed Army Medical Center
Overall Status: Completed

Phase

3

Condition

Dyskinesias

Williams Syndrome

Manic Disorders

Treatment

N/A

Clinical Study ID

NCT00479531
05-17018
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to determine if sequential compression devices (SCD) when worn for an hour per day by patients suffering from Restless Legs Syndrome (RLS) are helpful for the improvement of the RLS symptoms and sleep.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age greater than 17 years with a reliable diagnosis of RLS in accordance with theInternational Classification of Sleep Disorders, Revised Diagnostic and Coding Manualof the American Academy of Sleep Medicine.

Exclusion

Exclusion Criteria:

  • Age less than 18 years

  • Unstable medical conditions that may interfere with the requirements of the study (forexample uncontrolled diabetes mellitus, symptomatic asthma, congestive heart failurewith symptoms of pulmonary edema), and mental or physical limitations (includingdementia) that would preclude data collection on questionnaires or wearing the SCD.

  • Other medical conditions that would serve as exclusion criteria are those whereincreased venous or lymphatic return is undesirable. These specific conditions areknown or suspected acute deep vein thrombosis, thrombophlebitis, severe congestiveheart failure, pulmonary edema, severe arteriosclerosis, active infection such asgangrene, recent vein ligation or skin graft, or extreme deformity of the legs.

Study Design

Total Participants: 40
Study Start date:
September 01, 2005
Estimated Completion Date:
October 31, 2007

Study Description

Restless legs syndrome (RLS) is a highly vexing problem manifested by sensory and motor symptoms that disrupt sleep onset or sleep maintenance. RLS is the second most common sleep disorder and occurs with an estimated prevalence of 10% in the general population. The sleep disruption results in daytime symptoms such as excessive daytime sleepiness (EDS) and mood changes. There are no consistently reliable treatment alternatives. There is an urgent need for new, innovative treatment strategies because available pharmacological treatments often stop working over time or are associated with unacceptable side effects. An effective nonpharmacological treatment would be a highly attractive alternative.

Anecdotally, patients have reported that use of sequential compression devices (SCD) prescribed for prophylaxis of deep vein thrombosis can have a positive effect on RLS symptoms. Because this nonpharmacological alternative is available, safe, and affordable, further investigation is warranted.

Simply stated, the null hypothesis is that SCD therapy does not have an impact on RLS symptoms.

Patients will be randomized to wearing SCDs or sham SCDs for an hour each day prior to the usual onset of the RLS symptoms. At baseline and at monthly follow-ups for 3 to 4 months, participants will complete questionnaires to assess the severity of the RLS symptoms, their daytime sleepiness, and the impact of the RLS on quality of life.

Connect with a study center

  • Christopher Lettieri MD

    Sleep Disorders Center, Walter Reed Army Medical Center, District of Columbia 20307-5001
    United States

    Site Not Available

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