Restless Legs Syndrome
Conditions
Keywords
Restless legs syndrome
Brief summary
The purpose of this study is to explore whether patients with restless legs syndrome (RLS) differ from healthy subjects in daytime and night time autonomic function and cardiovascular risk markers and whether 4 week treatment with pramipexole affects autonomic function and cardiovascular risk markers in patients with RLS.
Interventions
DRUGPramipexole
DRUGPlacebo
Sponsors
Insel Gruppe AG, University Hospital Bern
Cardiocentro Ticino
Mauro Manconi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
(all participants): * Willingness to participate and written informed consent * Aged 30 to 65 years at the time of screening * Body mass index (BMI) ≤ 30 * Unremarkable neurological and physical examination * Unremarkable standard blood parameter according to local reference values Additional Inclusion Criteria for Restless Legs Syndrome (RLS) Patients: * RLS according to current standard international criteria * RLS symptoms ≥ 2 times per week for ≥ 1 year and during the past 12 months. * Either current international RLS severity scale (IRLS) ≥ 15 or current IRLS ≥ 10 and RLS symptoms ≥ 4 times per week during the past 3 months.
Exclusion criteria
(all participants): * Pregnancy, or breast feeding at time of screening. * Recent anaesthesia (last 3 months). * Sleep related breathing disorders during nocturnal polysomnography: * Current history of psychiatric disorders according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). * Life time history of any diagnosis of, medication or intervention for cardiovascular diseases. * Current chronic treatment that may affect autonomic function. * Any significant neurological disease or diagnosed metabolic diseases that may affect cardiovascular function and/or increase cardiovascular risk. * Any unstable medical condition. * Smoking \> 5 cigarettes per day during the last 2 years. * Work involving night shifts (22:00 - 06:00 h) during the past 2 years. * Travel with \> 6 time zone differences during the past 6 months. * Participation in any other study involving investigational or marketed products concomitantly or within 3 months prior to the screening visit. * Current participation in other clinical trials. Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in heart rate activations during sleep from baseline to 4 weeks | Baseline, Week 4 | Number and amplitude of periodic leg movements during sleep (PLMS) and non-PLMS related heart rate activations during stable nocturnal sleep |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in baroreflex from baseline to 4 weeks | Baseline, Week 4 | Baroreflex sensitivity and baroreflex gain derived from tilt table tes |
| Change in blood serum markers from baseline to 4 weeks | Baseline, Week 4 | Highly-sensitive C reactive protein (hsCRP), lipoprotein-associated phospholipase A2 (lP-PLA2), and oxidised low density lipoprotein (oxLDL) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in chemoreflexes from baseline to 4 weeks | Baseline, Week 4 | Peripheral and central chemoreflex sensitivity derived from carbon dioxide (CO2) rebreathing test |
Countries
Switzerland
Outcome results
None listed