Sleepiness in Parkinson's Patients With Continuous Dopaminergic Delivery Device or Deep Brain Stimulation

Parkinson Disease Clinical Trial

Official title:

Monitoring of Sleepiness in Patients With Parkinson's Disease Before and During Treatment With Continuous Dopaminergic Delivery Device or Deep Brain Stimulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04441697
• Other study ID #: 2020PI085
• Status: Recruiting
• Start date: June 1, 2020
• Est. completion date: June 2023

Study information

• Verified date: July 2021
• Source: Central Hospital, Nancy, France
• Contact: Nicolas Carpentier
• Phone: 0033383858585
• Email: n.carpentier[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Sleepiness is frequent in parkinsonian patients, increasing with the duration of disease. By patients with motor fluctuations, continuous dopaminergic delivery devices or deep brain stimulation are justified to improve the motor prognosis. Antiparkinsonian treatments, especially dopaminergic agonists, may worsen the sleepiness and thus affect the quality of life. The investigators aimed to monitor sleepiness in parkinsonian patients before and during treatment with continous dopaminergic delivery device or deep brain stimulation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patient with Parkinson's disease and motor fluctuations
• and indicated for a continuous dopaminergic delivery device or deep brain stimulation

Exclusion Criteria:

• age < 18 years
• refusal for the continuous dopaminergic delivery device or deep brain stimulation
• wake-promoting drugs intake
• refusal to participate
• legal protection
• uncontrolled sleep apnea

Related Conditions & MeSH terms

• Parkinson Disease
• Sleepiness

Intervention

Diagnostic Test:
• Multiple sleep latency tests
The investigators measure the objective sleepiness by recording the electro-encephalogramm during four experimental diurnal naps. They also perform a nocturnal polysomnography prior to the tests for a better interpretation.

Locations

Country	Name	City	State
France	Nancy University Hospital	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean sleep latency	Algebric mean (in minutes) of the sleep latency for the four experimental naps	before continuous antiparkinsonian treatment
Primary	Mean sleep latency	Algebric mean (in minutes) of the sleep latency for the four experimental naps	6 months after continuous antiparkinsonian treatment
Primary	Mean sleep latency	Algebric mean (in minutes) of the sleep latency for the four experimental naps	12 months after continous antiparkinsonian treatment