Status:
UNKNOWN
Gut Microbiota and Bacterial Translocation in Restless Legs Syndrome
Lead Sponsor:
University Hospital, Montpellier
Conditions:
Restless Legs Syndrome
Eligibility:
All Genders
18+ years
Brief Summary
Restless Legs Syndrome (RLS) is a common neurological sensorimotor disorder defined by an urge to move the legs when at rest that increase in the evening and at night. The pathophysiology of RLS remai...
Detailed Description
Sixty patients with RLS will be included and 60 controls. The patients will be recruited from the active file of the sleep and wake disorders unit. The control subjects will be recruited from : * Pa...
Eligibility Criteria
Inclusion
- Patient
- Idiopathic RLS diagnosed according to the 5 clinical criteria established by the IRLSSG (International Restless Legs Syndrome Study Group).
- Moderate to very severe RLS, IRLSSG questionnaire ≥ 15.
- Presence of periodic leg movements (PLM) during sleep (PLM index \> 15/hour of sleep).
- Patient never treated or weaned at least 15 days prior to evaluation with dopaminergic agonists, alpha-2delta ligands, opioids or other psychotropic drugs.
Exclusion
- Patient
- Presence of digestive, inflammatory, psychiatric or neurological pathologies.
- C-reactive protein \> 10mg/l (marker of acute inflammation)
- Presence of moderate-to-severe sleep apnea syndrome (apnea-hypopnea index \>15/h).
- History of iron supplementation within 6 months.
- Use of treatments known to aggravate or cause RLS, such as antidepressants, neuroleptics, antihistamines or lithium.
- Refusal of consent after information
- legally protected adult (guardianship, curatorship)
- Pregnant or breast-feeding women
- Patient not affiliated to or not benefiting from a social security system.
- Inclusion Criteria:
- Control
- Adults without RLS with demographic characteristics similar to patients in terms of age (+- 5 years) and gender
Key Trial Info
Start Date :
January 9 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05985421
Start Date
January 9 2024
End Date
September 30 2025
Last Update
May 20 2024
Active Locations (1)
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1
Unité des troubles du sommeil et de l'éveil-Centre de référence narcolepsie-Hypersomnie/Département de Neurologie/ Pole neurosciences tête et cou Hôpital Gui De Chauliac
Montpellier, France, 34295