Parkinson DiseaseNCT04441697
Sleepiness in Parkinson's Patients With Continuous Dopaminergic Delivery Device or Deep Brain Stimulation
An observational study of Parkinson Disease, run by Central Hospital, Nancy, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Multiple sleep latency tests
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2020to Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- patient with Parkinson's disease and motor fluctuations
- and indicated for a continuous dopaminergic delivery device or deep brain stimulation
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Nancy University Hospital
Nancy, 54000
Nicolas Carpentier, n.carpentier@chru-nancy.fr
About this study
Official title: 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.
- Conditions
- Parkinson Disease
- Being tested
- Multiple sleep latency tests
- Keywords
- continous dopaminergic delivery device, deep brain stimulation, sleepiness
- Medical subject headings
- Parkinson Disease, Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple sleep latency testsDiagnostic test
Also called Polysomnography
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.
| Study group | Role | What they receive |
|---|---|---|
| continuous apomorphine delivery | apomorphine, subcutaneous administration, continuous delivery during 8 to 24 hours/day Receives: Diagnostic Test: Multiple sleep latency tests | |
| continous levodopa/carbidopa delivery | levodopa/carbidopa monohydrate, jejunal administration, continuous delivery during 8 to 24 hours/day Receives: Diagnostic Test: Multiple sleep latency tests | |
| deep brain stimulation | bilateral subthalamic electrical stimulation, intracranial neurosurgical electrodes, individual electrical parameters settings Receives: Diagnostic Test: Multiple sleep latency tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean sleep latency
Algebric mean (in minutes) of the sleep latency for the four experimental naps
Measured: before continuous antiparkinsonian treatment
Mean sleep latency
Algebric mean (in minutes) of the sleep latency for the four experimental naps
Measured: 6 months after continuous antiparkinsonian treatment
Mean sleep latency
Algebric mean (in minutes) of the sleep latency for the four experimental naps
Measured: 12 months after continous antiparkinsonian treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Jun 2020
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- El Mehdi Siaghy, Study chair, Research and Innovation Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441697
- Sponsor's protocol ID
- 2020PI085
- Status last verified
- Jul 2021
- First submitted
- 18 Jun 2020
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Sleepiness in Patients With Parkinson's Disease Before and During Treatment With Continuous Dopaminergic Delivery Device or Deep Brain Stimulation
- ClinicalTrials.gov ID
- NCT04441697
- Acronym / sponsor ID
- 2020PI085
- Conditions
- Parkinson Disease
- Keywords
- continous dopaminergic delivery device, deep brain stimulation, sleepiness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 22 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| continuous apomorphine delivery | – | Diagnostic Test: Multiple sleep latency testsapomorphine, subcutaneous administration, continuous delivery during 8 to 24 hours/day |
| continous levodopa/carbidopa delivery | – | Diagnostic Test: Multiple sleep latency testslevodopa/carbidopa monohydrate, jejunal administration, continuous delivery during 8 to 24 hours/day |
| deep brain stimulation | – | Diagnostic Test: Multiple sleep latency testsbilateral subthalamic electrical stimulation, intracranial neurosurgical electrodes, individual electrical parameters settings |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- patient with Parkinson's disease and motor fluctuations
- and indicated for a continuous dopaminergic delivery device or deep brain stimulation
Key exclusion criteria (6 listed)
- age < 18 years
- refusal for the continuous dopaminergic delivery device or deep brain stimulation
- wake-promoting drugs intake
- refusal to participate
- legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiple sleep latency testsAlso: PolysomnographyThe 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. | Diagnostic test | continous levodopa/carbidopa delivery, continuous apomorphine delivery, deep brain stimulation |
Primary outcome
Mean sleep latency
Time frame: before continuous antiparkinsonian treatment
Algebric mean (in minutes) of the sleep latency for the four experimental naps
Mean sleep latency
Time frame: 6 months after continuous antiparkinsonian treatment
Algebric mean (in minutes) of the sleep latency for the four experimental naps
Mean sleep latency
Time frame: 12 months after continous antiparkinsonian treatment
Algebric mean (in minutes) of the sleep latency for the four experimental naps
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
El Mehdi Siaghy study chair
Research and Innovation Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Carpentier (0033383858585, n.carpentier@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean sleep latency (time frame: before continuous antiparkinsonian treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.