Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-24 @ 7:48 PM
NCT ID:
NCT02021903
Eligibility Criteria:
Inclusion Criteria:
* Aged 35 to 85
* Parkinson's disease patients (UKPDSBB diagnostic criteria), patients with Dementia with Lewy Bodies (DLB consortium criteria, Mc Keith et al. 2005) or patients with Multiple System Atrophy (Gilman's criteria, 2008) complaining of a post-prandial sleepiness interfering with their daily living and with orthostatic hypotension
* Stable antiparkinsonian treatments (including those for dysautonomia) for the 2 months before the study and during the entire study
* Signed written informed consent for the present study
* Social security insurance coverage
Exclusion Criteria:
* atypical or secondary parkinsonism
* patients without excessive daytime sleepiness
* inability to give a consent due to severe cognitive dysfunction
* severe depression
* Deep brain stimulation treatment
* Moderate to severe obstructive sleep apnoea/hypopnoea syndrome or other co-morbidities that could account for abnormal daytime sleepiness
* Severe primary or secondary insomnia
* Treatment with sedative medications (unless moderate and stable treatment for more than 2 months before entering the study and maintained at stable dosage during all the study)
* Diabetes mellitus
* Systolic arterial pressure at rest in seated position lower than 100 mmHg in sitting position
* Pregnancy and suckling
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
85 Years
Study:
NCT02021903
Study Brief:
Protocol Section:
NCT02021903