Status:
WITHDRAWN
Circadian & Homeostatic Synchronization Effect on Waking Mobility in Parkinson's Disease
Lead Sponsor:
University Hospital Center of Martinique
Conditions:
Parkinson's Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Sleep benefit (SB) consists of a spontaneous, transient and inconsistent improvement of the mobility occurring on morning awakening in approximately 40% of Parkinson's disease (PD) patients, before ta...
Detailed Description
Parkinson's disease is a common neurodegenerative disorder touching 1.5% of the general population over 60 year-old and featuring impaired mobility with high impact on daily living and quality of life...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04467632
Start Date
October 1 2019
End Date
April 1 2022
Last Update
July 13 2020
Active Locations (1)
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1
CHU de Martinique
Fort-de-France, France, 97200