Sequential Compression Devices for Treatment of Restless Legs Syndrome
Completed · Phase 3
Conditions studied: Restless Legs Syndrome
In brief
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.
Key facts
- Study ID
- NCT00479531
- Run by
- Walter Reed Army Medical Center
- People needed
- 40
- Starts
- 2005-09-01
- Expected to finish
- 2007-10-01
- Last updated by the study team
- 2007-11-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age greater than 17 years with a reliable diagnosis of RLS in accordance with the International Classification of Sleep Disorders, Revised Diagnostic and Coding Manual of the American Academy of Sleep Medicine.
You may not qualify if…
- Age less than 18 years
- Unstable medical conditions that may interfere with the requirements of the study (for example uncontrolled diabetes mellitus, symptomatic asthma, congestive heart failure with symptoms of pulmonary edema), and mental or physical limitations (including dementia) that would preclude data collection on questionnaires or wearing the SCD.
- 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 acute deep vein thrombosis, thrombophlebitis, severe congestive heart failure, pulmonary edema, severe arteriosclerosis, active infection such as gangrene, recent vein ligation or skin graft, or extreme deformity of the legs.
Where it is running
- Christopher Lettieri MD — Sleep Disorders Center, Walter Reed Army Medical Center, District of Columbia, United States
Full record on ClinicalTrials.gov
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