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 @ 9:28 PM
Ignite Modification Date:
2025-12-24 @ 9:28 PM
NCT ID:
NCT04467632
Eligibility Criteria:
Inclusion Criteria:
* Patients \> 18 years old;
* Patients affected with idiopathic PD, of both sexes;
* Hoehn and Yahr stage of 2 to 4 in the "on" state;
* Stable antiparkinsonian and/or psychotropic medications for at least 4 weeks prior to study screening;
* Reliable partner/caregiver to assist the patient during the study procedures;
* Affiliated person or beneficiary of a social security scheme;
* Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
Exclusion Criteria:
* Patients \< 18 years old;
* Atypical parkinsonian syndromes;
* Dementia;
* Treatment with extended-release dopaminergic drugs (excluding extended release levodopa given no later than 6 hours before the habitual bedtime);
* Use of hypno-sedative drugs or stimulants;
* Use of antidepressants unless on a stable dose for at least 3 months;
* Travel through 2 time zones within 90 days prior to study screening;
* Visual abnormalities that may interfere with light therapy, such as significant cataracts, narrow angle glaucoma or blindness;
* Any other medical condition potentially interfering with the assessment of mobility (e.g. limb amputation, post-stroke paralysis, severe osteo-articular condition);
* Any condition limiting the capability of the subject to understand the task to be performed at home by the patient himself (e.g. aphasia, oligophrenia);
* Severely altered physical and/or psychological health which, according to, the investigator, could affect the participant's compliance of the study;
* Inadequate housing conditions to perform home assessments;
* Patients refusing to participate in the study;
* Patients under legal guardianship or curatorship, pregnant and breastfeeding women, women of child-bearing age, persons in emergency situations;
* Persons participating in another research including a period of exclusion still in course and at any case \< 1 month.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04467632
Study Brief:
Protocol Section:
NCT04467632