Sequential Compression Devices for Treatment of Restless Legs Syndrome - Full Text View

Sponsors and Collaborators:	Walter Reed Army Medical Center AirCast LLC
Information provided by:	Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:	NCT00479531

Purpose

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	Intervention	Phase
Restless Legs Syndrome	Device: AirCast Sequential Compression Device	Phase III

MedlinePlus related topics: Restless Legs

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Sequential Compression Devices for Treatment of Restless Legs Syndrome - a Prospective, Randomized, Sham-Controlled Study

Further study details as provided by Walter Reed Army Medical Center:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	40
Study Start Date:	September 2005
Study Completion Date:	October 2007

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00479531

Locations

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

Investigators

Principal Investigator:

Christopher Lettieri, MD

Pulmonary & Critical Care Medicine Service, Walter Reed Army Medical Center, Washington DC

More Information

No publications provided by Walter Reed Army Medical Center

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Lettieri CJ, Eliasson AH. Pneumatic compression devices are an effective therapy for restless legs syndrome: a prospective, randomized, double-blinded, sham-controlled trial. Chest. 2009 Jan;135(1):74-80. Epub 2008 Nov 18.

Study ID Numbers:	05-17018
Study First Received:	May 25, 2007
Last Updated:	November 29, 2007
ClinicalTrials.gov Identifier:	NCT00479531 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Walter Reed Army Medical Center:

Restless Legs Syndrome
Sequential Compression Device
Sleep Quality
Quality of Life

Study placed in the following topic categories:

Signs and Symptoms
Mental Disorders
Restless Legs Syndrome
Quality of Life
Neurologic Manifestations
Dyssomnias

Sleep Disorders
Psychomotor Agitation
Neurobehavioral Manifestations
Dyskinesias
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Disease
Nervous System Diseases
Parasomnias
Dyssomnias
Sleep Disorders
Psychomotor Agitation
Dyskinesias
Sleep Disorders, Intrinsic

Signs and Symptoms
Pathologic Processes
Mental Disorders
Syndrome
Restless Legs Syndrome
Psychomotor Disorders
Neurologic Manifestations
Neurobehavioral Manifestations

ClinicalTrials.gov processed this record on May 07, 2009