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

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 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Sequential Compression Devices for Treatment of Restless Legs Syndrome - a Prospective, Randomized, Sham-Controlled Study

Resource links provided by NLM:

Genetics Home Reference related topics: restless legs syndrome

MedlinePlus related topics: Restless Legs

U.S. FDA Resources

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. doi: 10.1378/chest.08-1665. Epub 2008 Nov 18.


ClinicalTrials.gov Identifier:	NCT00479531 History of Changes
Other Study ID Numbers:	05-17018
Study First Received:	May 25, 2007
Last Updated:	November 29, 2007
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

Additional relevant MeSH terms:


Syndrome Psychomotor Agitation Restless Legs Syndrome Disease Pathologic Processes Dyskinesias Neurologic Manifestations Nervous System Diseases	Psychomotor Disorders Neurobehavioral Manifestations Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Parasomnias Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2016