Vasculaire Leg Compression Device for the Treatment of Restless Legs Syndrome - A Prospective Clinical Study

NCT01861652 | Withdrawn

• 1 other identifier: 388140
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Restless legs syndrome (RLS) is a debilitating sleep disorder that has significant impact on quality of life, and often times can be difficult to diagnose and treat effectively. RLS is typically treated with medical therapy (including dopaminergic agents, dopamine agonists, benzodiazepines, anticonvulsants, opiates, among other therapies). Many patients are either refractory to medical therapy, have contraindications or adverse reactions to the available medical therapies, or desire conservative non-medication based therapies. Two previous studies have demonstrated that pneumatic compression devices placed on the legs can improve symptoms of RLS. We would like to assess whether the Venous Health Systems Vasculaire leg compression device improves symptoms and quality of life measures related to RLS in up to 40 patients evaluated prospectively for one month. This is a pilot study to assess the subjective response of our cohort of patients to this device prospectively. Our hypothesis is that over 66% of our cohort will demonstrate a positive symptomatic response based on RLS specific quality of life questionnaires.

Conditions

Restless Legs Syndrome,; Restless Legs,; Ekbom Syndrome

Keywords

Restless legs syndrome, Ekbom syndrome, Restless legs

Outcome Measures

Primary Outcomes (5)

• The Restless Legs Syndrome Rating Scale

  the patient rates their symptoms of RLS on a severity scale (none (0), mild (1-10), moderate (11-20), severe (21-30), very severe (31-40))

  one month

• The Restless Legs Syndrome-Quality of Life Instrument (RLS-QLI)

  18 questions assessing how RLS has affected patient's quality of life over the preceding month.

  one month

• The Epworth Sleepiness Scale (ESS)

  A validated questionnaire for assessing daytime sleepiness; propensity to fall asleep during routine daily tasks/events.

  one month

• The Johns Hopkins Restless Legs Severity Scale (JHRLS)

  assesses how severe a patient's RLS symptoms are at different points in the day (symptoms occuring earlier in the day is worse). Severity graded as 0=never, 0.5=infrequent, 1=mild, 2=moderate, 3=severe, 4=very severe

  one month

• The International Restless Legs Syndrome Rating Scale

  assesses a patient's symptoms of RLS over the preceding week in terms of severity (numeric score)

  1, 2, 3, 4 weeks

Study Arms (1)

Venous health systems Vasculaire leg compression device

EXPERIMENTAL

Vasculaire leg compression device

Device: Venous Health Systems Vasculaire Leg Compression Device

Interventions

Venous Health Systems Vasculaire Leg Compression Device DEVICE

Leg (calf) compression device used to alleviate symptoms of restless legs

Also known as: intermittent pneumatic compression device; sequential intermittent pneumatic compression device

Venous health systems Vasculaire leg compression device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who are at least 18 years of age with a reliable diagnosis of RLS in accordance with the International Classification of Sleep Disorder, Revised Diagnostic and Coding Manual of the American Academy of Sleep Medicine. All patients included must have persistent symptoms that interfere with quality of life. Patients who are currently on approved medical therapy for RLS must be on a stable dose/agent for ≥30 days and experience persistent symptoms that interfere with quality of life. Patients who are currently refractory to medical therapies may also be included if they are presently under the care of a physician and receiving medical therapy for RLS for ≥30 days without improvement and/or having experienced unacceptable side effects. Pregnancy status is not being assessed and is not relevant to device use.

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Related Publications (2)

• 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.

  PMID: 19017878 BACKGROUND

• Eliasson AH, Lettieri CJ. Sequential compression devices for treatment of restless legs syndrome. Medicine (Baltimore). 2007 Nov;86(6):317-323. doi: 10.1097/MD.0b013e31815b1319.

  PMID: 18004176 BACKGROUND

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Intermittent Pneumatic Compression Devices

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Jacob F Collen, MD

  Pulmonary, Critical Care, Sleep Medicine

  PRINCIPAL INVESTIGATOR

• Christopher J Lettieri, MD

  Pulmonary, Critical Care, Sleep Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2013
• First Posted: May 23, 2013
• Study Start: July 1, 2013
• Primary Completion: January 1, 2014
• Last Updated: June 16, 2015

Record last verified: 2013-05

Locations

US (1)