Restless Legs SyndromePhase 3NCT00479531
Sequential Compression Devices for Treatment of Restless Legs Syndrome
A Phase 3 study testing AirCast Sequential Compression Device in people with Restless Legs Syndrome, run by Walter Reed Army Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Restless Legs Syndrome
- What is being tested?
- AirCast Sequential Compression Device
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Oct 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Christopher Lettieri MD
Sleep Disorders Center, Walter Reed Army Medical Center, District of Columbia, 20307-5001
About this study
Official title: Sequential Compression Devices for Treatment of Restless Legs Syndrome - a Prospective, Randomized, Sham-Controlled Study
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.
Read the 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.
- Conditions
- Restless Legs Syndrome
- Being tested
- AirCast Sequential Compression Device
- Keywords
- Restless Legs Syndrome, Sequential Compression Device, Sleep Quality, Quality of Life
- Medical subject headings
- Restless Legs Syndrome, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AirCast Sequential Compression DeviceDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of RLS Symptom Score; Epworth Sleepiness Scale; Quality of Life Scores (RLS-QLI)
Measured: 3 to 4 months
Secondary outcomes (1)
Compliance with SCD therapy by patient diary; Patient subjective experience by personal comments.
Measured: 3 to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2007 (estimated)
- Study startSep 2005
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- AirCast LLC
- Investigators
- Christopher Lettieri, MD, Principal investigator, Pulmonary & Critical Care Medicine Service, Walter Reed Army Medical Center, Washington DC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00479531
- Sponsor's protocol ID
- 05-17018
- Status last verified
- Oct 2007
- First submitted
- 25 May 2007
- Last updated
- 30 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19017878
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Compression Devices for Treatment of Restless Legs Syndrome - a Prospective, Randomized, Sham-Controlled Study
- ClinicalTrials.gov ID
- NCT00479531
- Acronym / sponsor ID
- 05-17018
- Conditions
- Restless Legs Syndrome
- Keywords
- Restless Legs Syndrome, Sequential Compression Device, Sleep Quality, Quality of Life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Walter Reed Army Medical CenterUS federal agency
- Collaborators
- AirCast LLC
- Study start
- Sep 2005
- Study completion
- Oct 2007 (actual)
- First posted
- 28 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AirCast Sequential Compression Device | Device | – |
Primary outcome
Severity of RLS Symptom Score; Epworth Sleepiness Scale; Quality of Life Scores (RLS-QLI)
Time frame: 3 to 4 months
1 secondary outcome
Compliance with SCD therapy by patient diary; Patient subjective experience by personal comments.
Time frame: 3 to 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2007.
- Derived from this study: PubMed 19017878Lettieri 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Lettieri, MD principal investigator
Pulmonary & Critical Care Medicine Service, Walter Reed Army Medical Center, Washington DC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AirCast Sequential Compression Device in people with Restless Legs Syndrome, run by Walter Reed Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of RLS Symptom Score; Epworth Sleepiness Scale; Quality of Life Scores (RLS-QLI) (time frame: 3 to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00479531, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2007.