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

NCT04441697 | Unknown DMC

• 1 other identifier: 2020PI085
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Keywords

continous dopaminergic delivery device; deep brain stimulation; sleepiness

Outcome Measures

Primary Outcomes (3)

• Mean sleep latency

  Algebric mean (in minutes) of the sleep latency for the four experimental naps

  before continuous antiparkinsonian treatment

• Mean sleep latency

  Algebric mean (in minutes) of the sleep latency for the four experimental naps

  6 months after continuous antiparkinsonian treatment

• Mean sleep latency

  Algebric mean (in minutes) of the sleep latency for the four experimental naps

  12 months after continous antiparkinsonian treatment

Study Arms (3)

continuous apomorphine delivery

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

Diagnostic Test: Multiple sleep latency tests

continous levodopa/carbidopa delivery

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

Diagnostic Test: Multiple sleep latency tests

deep brain stimulation

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

Diagnostic Test: Multiple sleep latency tests

Interventions

Multiple sleep latency tests DIAGNOSTIC_TEST

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.

Also known as: Polysomnography

continous levodopa/carbidopa delivery; continuous apomorphine delivery; deep brain stimulation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the patients refered to the expert Parkinson Center of the Nancy University Hospital, with the diagnosis of Parkinson's disease at the stage of motor fluctuations, and indicated for a continuous dopaminergic delivery device or deep brain stimulation

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Nancy University Hospital

Nancy, 54000, France

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Sleepiness

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• El Mehdi Siaghy

  Research and Innovation Department

  STUDY CHAIR

Central Study Contacts

Nicolas Carpentier

CONTACT

0033383858585; n.carpentier@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 22, 2020
• Study Start: June 1, 2020
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: August 6, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)