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Sequential Compression Devices for Treatment of Restless Legs Syndrome

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ClinicalTrials.gov Identifier: NCT00479531
Recruitment Status : Completed
First Posted : May 28, 2007
Last Update Posted : November 30, 2007
AirCast LLC
Information provided by:
Walter Reed Army Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Restless Legs Syndrome Device: AirCast Sequential Compression Device Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Sequential Compression Devices for Treatment of Restless Legs Syndrome - a Prospective, Randomized, Sham-Controlled Study
Study Start Date : September 2005
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs

Primary Outcome Measures :
  1. Severity of RLS Symptom Score; Epworth Sleepiness Scale; Quality of Life Scores (RLS-QLI) [ Time Frame: 3 to 4 months ]

Secondary Outcome Measures :
  1. Compliance with SCD therapy by patient diary; Patient subjective experience by personal comments. [ Time Frame: 3 to 4 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00479531

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United States, District of Columbia
Christopher Lettieri MD
Sleep Disorders Center, Walter Reed Army Medical Center, District of Columbia, United States, 20307-5001
Sponsors and Collaborators
Walter Reed Army Medical Center
AirCast LLC
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Principal Investigator: Christopher Lettieri, MD Pulmonary & Critical Care Medicine Service, Walter Reed Army Medical Center, Washington DC
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00479531    
Other Study ID Numbers: 05-17018
First Posted: May 28, 2007    Key Record Dates
Last Update Posted: November 30, 2007
Last Verified: October 2007
Keywords provided by Walter Reed Army Medical Center:
Restless Legs Syndrome
Sequential Compression Device
Sleep Quality
Quality of Life
Additional relevant MeSH terms:
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Psychomotor Agitation
Restless Legs Syndrome
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Mental Disorders