NCT00479531

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 28, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

November 30, 2007

Status Verified

October 1, 2007

First QC Date

May 25, 2007

Last Update Submit

November 29, 2007

Conditions

Restless Legs Syndrome

Keywords

Restless Legs SyndromeSequential Compression DeviceSleep QualityQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Severity of RLS Symptom Score; Epworth Sleepiness Scale; Quality of Life Scores (RLS-QLI)

    3 to 4 months

Secondary Outcomes (1)

  • Compliance with SCD therapy by patient diary; Patient subjective experience by personal comments.

    3 to 4 months

Interventions

AirCast Sequential Compression DeviceDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christopher Lettieri MD

Sleep Disorders Center, Walter Reed Army Medical Center, District of Columbia, 20307-5001, United States

Location

Related Publications (1)

  • 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: 19017878DERIVED

MeSH Terms

Conditions

Restless Legs SyndromeSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Nervous System DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersParasomniasMental Disorders

Study Officials

  • Christopher Lettieri, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

May 25, 2007

First Posted

May 28, 2007

Study Start

September 1, 2005

Study Completion

October 1, 2007

Last Updated

November 30, 2007

Record last verified: 2007-10

Locations

US(1)