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

Central Hospital, Nancy, France

Status: Unknown

Conditions: Parkinson Disease

Treatments: Diagnostic Test: Multiple sleep latency tests

Study type: Observational

Funder types: Other

Identifiers

NCT04441697

2020PI085

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 3 patient groups

continuous apomorphine delivery

Description:

apomorphine, subcutaneous administration, continuous delivery during 8 to 24 hours/day

Treatment:

Diagnostic Test: Multiple sleep latency tests

continous levodopa/carbidopa delivery

Description:

levodopa/carbidopa monohydrate, jejunal administration, continuous delivery during 8 to 24 hours/day

Treatment:

Diagnostic Test: Multiple sleep latency tests

deep brain stimulation

Description:

bilateral subthalamic electrical stimulation, intracranial neurosurgical electrodes, individual electrical parameters settings

Treatment:

Diagnostic Test: Multiple sleep latency tests