- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00479531
Sequential Compression Devices for Treatment of Restless Legs Syndrome
Sequential Compression Devices for Treatment of Restless Legs Syndrome - a Prospective, Randomized, Sham-Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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District of Columbia
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Sleep Disorders Center, Walter Reed Army Medical Center, District of Columbia, United States, 20307-5001
- Christopher Lettieri MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Severity of RLS Symptom Score; Epworth Sleepiness Scale; Quality of Life Scores (RLS-QLI)
Time Frame: 3 to 4 months
|
3 to 4 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Compliance with SCD therapy by patient diary; Patient subjective experience by personal comments.
Time Frame: 3 to 4 months
|
3 to 4 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christopher Lettieri, MD, Pulmonary & Critical Care Medicine Service, Walter Reed Army Medical Center, Washington DC
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (ACTUAL)
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
- 05-17018
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.
Clinical Trials on Restless Legs Syndrome
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Walter Reed National Military Medical CenterWithdrawnEkbom Syndrome | Restless Legs Syndrome, | Restless Legs,United States
-
GlaxoSmithKlineCompletedRestless Legs Syndrome | Restless Legs Syndrome (RLS)United States
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Otsuka Pharmaceutical Co., Ltd.CompletedIdiopathic Restless Legs Syndrome
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XenoPort, Inc.CompletedRestless Legs Syndrome (RLS)United States
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American Regent, Inc.CompletedRestless Legs Syndrome (RLS)United States
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Astellas Pharma IncCompletedRestless Legs Syndrome (RLS)Japan
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Otsuka Pharmaceutical Co., Ltd.CompletedIdiopathic Restless Legs SyndromeJapan
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UCB PharmaCompletedIdiopathic Restless Legs SyndromeGermany
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Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedIdiopathic Restless Legs SyndromeUnited States, Spain, Finland, Italy, Germany, Sweden, Austria, Netherlands, United Kingdom
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American Regent, Inc.CompletedRestless Legs Syndrome (RLS)
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