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

July 30, 2021 updated by: Central Hospital, Nancy, France

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
continuous apomorphine delivery
apomorphine, subcutaneous administration, continuous delivery during 8 to 24 hours/day
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.
Other Names:
  • Polysomnography
continous levodopa/carbidopa delivery
levodopa/carbidopa monohydrate, jejunal administration, continuous delivery during 8 to 24 hours/day
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.
Other Names:
  • Polysomnography
deep brain stimulation
bilateral subthalamic electrical stimulation, intracranial neurosurgical electrodes, individual electrical parameters settings
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.
Other Names:
  • Polysomnography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean sleep latency
Time Frame: before continuous antiparkinsonian treatment
Algebric mean (in minutes) of the sleep latency for the four experimental naps
before continuous antiparkinsonian treatment
Mean sleep latency
Time Frame: 6 months after continuous antiparkinsonian treatment
Algebric mean (in minutes) of the sleep latency for the four experimental naps
6 months after continuous antiparkinsonian treatment
Mean sleep latency
Time Frame: 12 months after continous antiparkinsonian treatment
Algebric mean (in minutes) of the sleep latency for the four experimental naps
12 months after continous antiparkinsonian treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Study Chair: El Mehdi Siaghy, Research and Innovation Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

June 18, 2020

First Submitted That Met QC Criteria

June 18, 2020

First Posted (Actual)

June 22, 2020

Study Record Updates

Last Update Posted (Actual)

August 6, 2021

Last Update Submitted That Met QC Criteria

July 30, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020PI085

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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