Restless Legs Syndrome,NCT01861652
Vasculaire Leg Compression Device for the Treatment of Restless Legs Syndrome - A Prospective Clinical Study
A study testing Venous Health Systems Vasculaire Leg Compression Device in people with Restless Legs Syndrome, and Restless Legs,, run by Walter Reed National Military Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Restless Legs Syndrome,, Restless Legs,, Ekbom Syndrome
- What is being tested?
- Venous Health Systems Vasculaire Leg Compression Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jan 2014
- Phase
- Interventional
- 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
- 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.
Who cannot join
- Younger than 18 years, unstable medical conditions that may interfere with the requirements of the study, e.g. diabetes mellitus, symptomatic asthma, congestive heart failure with nocturnal symptoms, and mental or physical limitation (including dementia) that would preclude data collection on questionnaires or wearing intermittent pneumatic compression devices. 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 deep vein thrombosis, thrombophlebitis, severe congestive heart failure, pulmonary edema, severe arteriosclerosis, action infection such as gangrene, recent vein ligation or skin graft, or extreme deformity of the legs. Patients with iron deficiency anemia, or evidence of inadequate serum iron stores on laboratory testing are also excluded until this has been corrected.
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
About this study
Official title: The Use of the Vasculaire Leg Compression Device for the Treatment of Restless Legs Syndrome - A Prospective Clinical Study
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.
Read the detailed description
BACKGROUND:
Restless Leg Syndrome (RLS) affects nearly 12 million Americans. Although the precise etiology of RLS is not well characterized, there are specific diagnostic criteria. Symptoms are typically worse in the evening, consisting of a strong urge to move the affected limb(s) and relief with movement. Current medical therapies pose several challenges for many patients, as side effects include extreme drowsiness, hallucinations, nausea, headaches and insomnia. An alternative, non-medical therapy may provide a suitable option to this subset of patients. Intermittent pneumatic compression devices have previously been studied in this population, and have demonstrated effectiveness. However prior models have required subjects to remain immobile during use, representing a significant limitation given that immobility may actually promote worsening of symptoms. An effective, alternative non-pharmacologic therapy that does not interfere with patient mobility should provide a valuable treatment option.
The purpose of this study is to assess whether the Vasculaire Intermittent Pneumatic Compression System will improve validated measures of symptom relief, patient satisfaction, and quality of life for RLS. This is a pilot study to determine whether or not the Vasculaire device improves validated measures of symptom relief, patient satisfaction, and quality of life in RLS patients. Depending on the outcome of our study we hope to develop a sham-controlled clinical trial as a follow-up study.
METHODS:
We are performing a Prospective cohort study.
We will recruit patients until we reach an N=40.
After informed consent, the patient's record will be reviewed to ensure that they have had a serum iron panel and ferritin checked within the preceding 6 months. For those patients missing these laboratory studies, they will have their blood drawn for a full serum iron panel (serum iron level, serum ferritin, and total iron binding capacity), as per standard of care (to exclude iron deficiency as a cause or contributor to their symptoms). Patients with inadequate serum iron stores will be excluded. Patients with adequate iron stores will be asked to complete a comprehensive medical questionnaire to document medical conditions and medications with doses prescribed.
This questionnaire will also record previously tried therapies, both home remedies and medically prescribed treatments. Specific undesirable side effects will also be documented.
Severity will then be determined based on 5 previously validated questionnaire instruments (The Restless Legs Syndrome Rating Scale, The Restless Legs Syndrome-Quality of Life Instrument (RLS-QLI), The Epworth Sleepiness Scale (ESS), The Johns Hopkins Restless Legs Severity Scale (JHRLS), The International Restless Legs Syndrome Rating Scale).
Once the medical history has been reviewed, documentation of severity assessed and the determination of unresolved treatment post medical therapy, the patient will be eligible for enrollment.
The Vasculaire Intermittent Pneumatic Compression System will be introduced to the patient and instructions provided on how to optimize the use of device in accordance with the study protocol.
- Conditions
- Restless Legs Syndrome,, Restless Legs,, Ekbom Syndrome
- Being tested
- Venous Health Systems Vasculaire Leg Compression Device
- Keywords
- Restless legs syndrome, Ekbom syndrome, Restless legs
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous Health Systems Vasculaire Leg Compression DeviceDevice
Also called intermittent pneumatic compression device; sequential intermittent pneumatic compression device
Leg (calf) compression device used to alleviate symptoms of restless legs
| Study group | Role | What they receive |
|---|---|---|
| Venous health systems Vasculaire leg compression device | Experimental | Vasculaire leg compression device Receives: Device: Venous Health Systems Vasculaire Leg Compression Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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))
Measured: 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.
Measured: one month
The Epworth Sleepiness Scale (ESS)
A validated questionnaire for assessing daytime sleepiness; propensity to fall asleep during routine daily tasks/events.
Measured: 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
Measured: 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)
Measured: 1, 2, 3, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startJul 2013
- Primary completionJan 2014 (estimated)
Why it stopped: sponsor withdrew support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Restless Legs Syndrome,Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jacob F Collen, MD, Principal investigator, Pulmonary, Critical Care, Sleep MedicineChristopher J Lettieri, MD, Study director, Pulmonary, Critical Care, Sleep Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861652
- Sponsor's protocol ID
- 388140
- Status last verified
- May 2013
- First submitted
- 21 May 2013
- Last updated
- 16 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
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 19017878Eliasson 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.
PubMed 18004176
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of the Vasculaire Leg Compression Device for the Treatment of Restless Legs Syndrome - A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT01861652
- Acronym / sponsor ID
- 388140
- Conditions
- Restless Legs Syndrome,, Restless Legs,, Ekbom Syndrome
- Keywords
- Restless legs syndrome, Ekbom syndrome, Restless legs
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: sponsor withdrew support
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Study start
- Jul 2013
- Primary completion
- Jan 2014 (estimated)
- First posted
- 23 May 2013 (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.
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.
Detailed description
BACKGROUND:
Restless Leg Syndrome (RLS) affects nearly 12 million Americans. Although the precise etiology of RLS is not well characterized, there are specific diagnostic criteria. Symptoms are typically worse in the evening, consisting of a strong urge to move the affected limb(s) and relief with movement. Current medical therapies pose several challenges for many patients, as side effects include extreme drowsiness, hallucinations, nausea, headaches and insomnia. An alternative, non-medical therapy may provide a suitable option to this subset of patients. Intermittent pneumatic compression devices have previously been studied in this population, and have demonstrated effectiveness. However prior models have required subjects to remain immobile during use, representing a significant limitation given that immobility may actually promote worsening of symptoms. An effective, alternative non-pharmacologic therapy that does not interfere with patient mobility should provide a valuable treatment option.
The purpose of this study is to assess whether the Vasculaire Intermittent Pneumatic Compression System will improve validated measures of symptom relief, patient satisfaction, and quality of life for RLS. This is a pilot study to determine whether or not the Vasculaire device improves validated measures of symptom relief, patient satisfaction, and quality of life in RLS patients. Depending on the outcome of our study we hope to develop a sham-controlled clinical trial as a follow-up study.
METHODS:
We are performing a Prospective cohort study.
We will recruit patients until we reach an N=40.
After informed consent, the patient's record will be reviewed to ensure that they have had a serum iron panel and ferritin checked within the preceding 6 months. For those patients missing these laboratory studies, they will have their blood drawn for a full serum iron panel (serum iron level, serum ferritin, and total iron binding capacity), as per standard of care (to exclude iron deficiency as a cause or contributor to their symptoms). Patients with inadequate serum iron stores will be excluded. Patients with adequate iron stores will be asked to complete a comprehensive medical questionnaire to document medical conditions and medications with doses prescribed.
This questionnaire will also record previously tried therapies, both home remedies and medically prescribed treatments. Specific undesirable side effects will also be documented.
Severity will then be determined based on 5 previously validated questionnaire instruments (The Restless Legs Syndrome Rating Scale, The Restless Legs Syndrome-Quality of Life Instrument (RLS-QLI), The Epworth Sleepiness Scale (ESS), The Johns Hopkins Restless Legs Severity Scale (JHRLS), The International Restless Legs Syndrome Rating Scale).
Once the medical history has been reviewed, documentation of severity assessed and the determination of unresolved treatment post medical therapy, the patient will be eligible for enrollment.
The Vasculaire Intermittent Pneumatic Compression System will be introduced to the patient and instructions provided on how to optimize the use of device in accordance with the study protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Venous health systems Vasculaire leg compression device | Experimental | Device: Venous Health Systems Vasculaire Leg Compression DeviceVasculaire leg compression device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Younger than 18 years, unstable medical conditions that may interfere with the requirements of the study, e.g. diabetes mellitus, symptomatic asthma, congestive heart failure with nocturnal symptoms, and mental or physical limitation (including dementia) that would preclude data collection on questionnaires or wearing intermittent pneumatic compression devices. 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 deep vein thrombosis, thrombophlebitis, severe congestive heart failure, pulmonary edema, severe arteriosclerosis, action infection such as gangrene, recent vein ligation or skin graft, or extreme deformity of the legs. Patients with iron deficiency anemia, or evidence of inadequate serum iron stores on laboratory testing are also excluded until this has been corrected.
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 |
|---|---|---|
| Venous Health Systems Vasculaire Leg Compression DeviceAlso: intermittent pneumatic compression device; sequential intermittent pneumatic compression deviceLeg (calf) compression device used to alleviate symptoms of restless legs | Device | Venous health systems Vasculaire leg compression device |
Primary outcome
The Restless Legs Syndrome Rating Scale
Time frame: one month
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))
The Restless Legs Syndrome-Quality of Life Instrument (RLS-QLI)
Time frame: one month
18 questions assessing how RLS has affected patient's quality of life over the preceding month.
The Epworth Sleepiness Scale (ESS)
Time frame: one month
A validated questionnaire for assessing daytime sleepiness; propensity to fall asleep during routine daily tasks/events.
The Johns Hopkins Restless Legs Severity Scale (JHRLS)
Time frame: one month
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
The International Restless Legs Syndrome Rating Scale
Time frame: 1, 2, 3, 4 weeks
assesses a patient's symptoms of RLS over the preceding week in terms of severity (numeric score)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2015.
- Background: 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.
- Background: PubMed 18004176Eliasson 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.
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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.
Jacob F Collen, MD principal investigator
Pulmonary, Critical Care, Sleep Medicine
Christopher J Lettieri, MD study director
Pulmonary, Critical Care, Sleep Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venous Health Systems Vasculaire Leg Compression Device in people with Restless Legs Syndrome, and Restless Legs,, run by Walter Reed National Military 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 1 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: withdrawn, as of the sponsor's last update on 16 Jun 2015. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
The Restless Legs Syndrome Rating Scale (time frame: one month). The study lists 5 primary outcomes in all. 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 NCT01861652, which also lists 2 linked publications.
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 16 Jun 2015.