Sequential Compression Devices for Treatment of Restless Legs Syndrome
|ClinicalTrials.gov Identifier: NCT00479531|
Recruitment Status : Completed
First Posted : May 28, 2007
Last Update Posted : November 30, 2007
|Condition or disease||Intervention/treatment||Phase|
|Restless Legs Syndrome||Device: AirCast Sequential Compression Device||Phase 3|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Sequential Compression Devices for Treatment of Restless Legs Syndrome - a Prospective, Randomized, Sham-Controlled Study|
|Study Start Date :||September 2005|
|Study Completion Date :||October 2007|
- Severity of RLS Symptom Score; Epworth Sleepiness Scale; Quality of Life Scores (RLS-QLI) [ Time Frame: 3 to 4 months ]
- Compliance with SCD therapy by patient diary; Patient subjective experience by personal comments. [ Time Frame: 3 to 4 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00479531
|United States, District of Columbia|
|Christopher Lettieri MD|
|Sleep Disorders Center, Walter Reed Army Medical Center, District of Columbia, United States, 20307-5001|
|Principal Investigator:||Christopher Lettieri, MD||Pulmonary & Critical Care Medicine Service, Walter Reed Army Medical Center, Washington DC|