Parkinson DiseaseSOMPARKNCT06582121
Study of Sleep Disorders in Prodromal and Definite Parkinsons Disease
A study testing Polysomnography in people with Parkinson Disease and REM Sleep Behavior Disorder (iRBD), run by Assistance Publique - Hôpitaux de Paris at 6 sites in France.
Trial summary
Multicenter controlled study of sleep disorders in isolated REM Behavior Disorder and Parkinson\'s disease (SOMPARK) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, REM Sleep Behavior Disorder (iRBD)
- What is being tested?
- Polysomnography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 457 participants
- Where
- 6 sitesFrance
- Study dates
- 18 Mar 2025to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Common to all groups:
- Age superior 18 years
- Patients who have received complete information about the study from an investigator and who fully consent to participate.
- For Parkinson Disease (PD):
- Patients followed for PD diagnosed according to international criteria for the diagnosis of PD (MDS criteria),
- A MoCA score greater than 20/30
Show all 12Show fewer
- No treatment with deep brain stimulation.
- For REM Sleep Behavior Disorder (RBD):
- Diagnosis of RBD according to ICSD-3 criteria: presence on polysomnography of an abnormal elevation of muscle tone during REM sleep (more than 18% of REM sleep without chin atonia) and/or the presence of REM sleep behaviors on video-polysomnography,
- Absence of progressive neurodegenerative pathology: absence of diagnostic criteria for PD, multiple system atrophy, or Lewy body dementia.
- For healthy controls:
- No neurological or psychiatric disease
Who cannot join
- Common to all groups:
- Pregnant or breastfeeding women
- Subjects under guardianship/conservatorship
- Persons deprived of liberty.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Maria-Livia FANTINI, MD, +33 (0)4 73 75 16 66, mfantini@chu-clermontferrand.fr
Maria-Livia FANTINI, MD
- Recruiting
CHU de Lille
Lille, 59037
Lise LANVIN, MD, +33 (0)3 20 44 63 62, Lise.LANVIN@chu-lille.fr
Lise LANVIN, MD
- Recruiting
CHU de Lyon
Lyon, 69004
Laure PETER-DEREX, MD, +33 (0)4 72 07 17 69, laure.peter-derex@chu-lyon.fr
Laure PETER-DEREX, MD
- Recruiting
CHU de Nantes
Nantes, 44093
Laurène LECLAIR-VISONNEAU, MD, +33 (0)2 40 16 55 10, Laurene.LECLAIR@chu-nantes.fr
Laurène LECLAIR-VISONNEAU, MD
- Recruiting
CHU de Nîmes
Nîmes, 30000
Beatriz ABRIL, MD, +33 (0)4 66 68 39 00, beatriz.abril@chu-nimes.fr
Beatriz ABRIL, MD
- Recruiting
CHU Pitié Salpêtrière
Paris, 75013
Pauline DODET, MD, +33(0)142167702, pauline.dodet@aphp.fr
Stéphane ATTARD, CRA, +33(0)142167712, stephane.attard@aphp.fr
About this study
Official title: Controlled, Multicenter Study of Sleep Disorders in Prodromal and Definite Parkinsons Disease
Multicenter controlled study of sleep disorders in isolated REM Behavior Disorder and Parkinson\'s disease (SOMPARK)
Read the detailed description
Sleep disturbances are common and understudied in established or prodromal Parkinson\'s disease. The purpose of this study is to systematically and comprehensively determine the clinical characteristics and electrophysiologic patterns of the major sleep disorders in PD and isolated RBD.
- Being tested
- Polysomnography
- Keywords
- Parkinson disease, isolated RBD, Sleep
- Medical subject headings
- Parkinson Disease, REM Sleep Behavior Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyOther
Also called Biology (urine, blood, faeces), Questionnaries, electromyogram, electroencephalogram
An overnight sleep study
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | Study of the sleep with polysomnography during a 2-days stay in hospital. Other exam will be done during the 2 days. Receives: Other: Polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polysomnography to compare sleep efficiency
Using polysomnography to compare sleep efficiency in the 3 study populations during the first night
Measured: 25 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start18 Mar 2025
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (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 Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participant will do polysomnographies during a 2-days stay in hospital with electroencephalogram, electromyogram and questionnaries. The urine will be also collected during 2 days.
- Masking
- None (open label)
- Enrolment
- 457 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582121
- Sponsor's protocol ID
- APHP230127
- Acronym
- SOMPARK
- Status last verified
- Mar 2026
- First submitted
- 30 Aug 2024
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled, Multicenter Study of Sleep Disorders in Prodromal and Definite Parkinsons Disease
- ClinicalTrials.gov ID
- NCT06582121
- Acronym / sponsor ID
- SOMPARK / APHP230127
- Keywords
- Parkinson disease, isolated RBD, Sleep
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 457 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 3 Sep 2024 (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.
Multicenter controlled study of sleep disorders in isolated REM Behavior Disorder and Parkinson\'s disease (SOMPARK)
Detailed description
Sleep disturbances are common and understudied in established or prodromal Parkinson\'s disease. The purpose of this study is to systematically and comprehensively determine the clinical characteristics and electrophysiologic patterns of the major sleep disorders in PD and isolated RBD.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participant will do polysomnographies during a 2-days stay in hospital with electroencephalogram, electromyogram and questionnaries. The urine will be also collected during 2 days.
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Other: PolysomnographyStudy of the sleep with polysomnography during a 2-days stay in hospital. Other exam will be done during the 2 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age superior 18 years
- Patients who have received complete information about the study from an investigator and who fully consent to participate.
- Patients followed for PD diagnosed according to international criteria for the diagnosis of PD (MDS criteria),
- A MoCA score greater than 20/30
- No treatment with deep brain stimulation.
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding women
- Subjects under guardianship/conservatorship
- Persons deprived of liberty.
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 |
|---|---|---|
| PolysomnographyAlso: Biology (urine, blood, faeces), Questionnaries, electromyogram, electroencephalogramAn overnight sleep study | Other | Participants |
Primary outcome
Polysomnography to compare sleep efficiency
Time frame: 25 months
Using polysomnography to compare sleep efficiency in the 3 study populations during the first night
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- 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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polysomnography in people with Parkinson Disease and REM Sleep Behavior Disorder (iRBD), run by Assistance Publique - Hôpitaux de Paris at 6 sites 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 12 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabelle ARNULF, Prof (+33 (0)1 42 16 77 04, isabelle.arnulf@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polysomnography to compare sleep efficiency (time frame: 25 months). 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 Mar 2026.