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

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.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.