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REM Sleep Behavior DisorderNCT03047408

Evolution of RBD in PD

A study testing Video polysomnography in people with REM Sleep Behavior Disorder and Parkinson's Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

About 60% of Parkinson's Disease (PD) patients have REM sleep Behavior Disorder (RBD), a parasomnia characterized by partial or complete loss of REM sleep muscle atonia and dream-enacting behaviors, usually associated to vivid dreams. Read more about this study

Who is it for?
Ages 45 to 85 years
What is being tested?
Video polysomnography
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteFrance
Study dates
Feb 2017to Jun 2019
Phase
Interventional
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 45 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with clinically confirmed idiopathic Parkinson's Disease, according to the United Kingdom Parkinson Disease Bran Bank criteria, associated with RBD, diagnosed according to the International Classification of Sleep Disorders third edition, that have been already enrolled in the study "RBHP 2013 DURIF", or that have already underwent vPSG recording,clinical and neuropsychiatric evaluation in clinical setting;
  • Male and female aged between 45 to 85 years old;
  • All patients are volunteers and have given written informed consent;
  • All patients are able to understand and to perform all tests included in this protocol;
  • User-friendly in French language, both oral and written

Who cannot join

  • Patients with neurological diseases other than PD;
  • Patients with psychiatric comorbidities (hallucinations, psychosis) according to the DSM-5.
  • Patients with Obstructive Sleep Apnea Syndrome (Apnea/hypopnea index >15/h);
  • Patients in guardianship or tutorship;
  • Patients enrolled exclusively in another study.

Trial locations and contacts

1 site in 1 country.

Patrick LACARIN contact

0473751195

placarin@chu-clermontferrand.fr

France1 site

  • Chu Clermont-Ferrand

    Clermont-Ferrand, 63003

    Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr

Other trials in France

About this study

Official title: Evolution of REM Sleep Behavior Disorder in Parkinson's Disease Patients RBD Diagnosed Three Years Earlier

About 60% of Parkinson's Disease (PD) patients have REM sleep Behavior Disorder (RBD), a parasomnia characterized by partial or complete loss of REM sleep muscle atonia and dream-enacting behaviors, usually associated to vivid dreams. The REM Sleep without atonia is the polysomnographic hallmark of RBD, and its quantification is necessary for the diagnosis.

RBD in PD is believed to be a marker of a more widespread degenerative process and a marker of malignant phenotype. Therefore, PD patients with RBD (PD-RBD) are more severely impaired in both motor and non-motor domains, compared to those without RBD, with an increased risk of dementia. However, little is know about the relationship between the evolution of RBD, clinic and video-polysomnographic, and the progression of PD. Besides, an improvement of RBD symptoms is anecdotally reported in PD patients over time. Longitudinal evaluation of RBD in PD, assessed by questionnaires, led to controversial results, but so far, no longitudinal vPSG study has been performed in PD-RBD population.

Thus, the main objective of this study is to longitudinally evaluate clinical and video-polysomnographic features of RBD, including measure of REM Sleep without atonia, in patients with PD-RBD, after three years from the diagnosis of RBD, in order to ascertain whether RBD features remain stable over time. The possible remission of RBD with the progression of PD would question indeed its reliability as prognostic bio-marker.

Read the detailed description

Type of study: longitudinal study, interventional, cross-sectional;

Number of centres: 1 (Clermont-Ferrand)

Patients: patients with Parkinson's Disease associated with REM sleep behavior disorder (PD-RBD) having already underwent video-polysomnography recording, clinical and neuropsychological evaluation in clinical setting or in the study "RBHP 2013 DURIF " at least three years ago.

Study performance:

This study will be developed in two phases:

  • Phase 1 (Day 0):
  • Verify inclusion criteria, receive informed and written consent;
  • Demographic and clinical characteristics;
  • Neurological evaluation: RBD (RBD severity scale), motor symptoms (Unified Parkinson's Disease Rating Scale, Hoeh et Yahr scale), orthostatic hypotension (Scale for outcomes in PD autonomic questionnaire), behavioral disorders hyper-dopaminergic and hypo-dopaminergic (Ardouin Scale of Behavior in Parkinson's Disease), impulsivity (Test Kirby and Stop signal reaction time)
  • Dreams contents: all patients will receive 3-weeks dream diary;
  • vPSG recording;
  • Self-assessment questionnaires: Non-motor symptoms Questionnaire, Epworth sleepiness scale, Urgency premeditation perseverance and sensation seeking test, Aggressive questionnaire, and the Hospital Anxiety and Depression Rating Scale
  • Phase 2 (+1day): Neuropsychological assessment of:
  • Cognitive function, namely executive functions, visuo-spatial functions, visuo-perceptive functions (Mini mental state examination, California Verbal Learning Test, verbal fluency test, Modified Wisconsin Card Sorting Test, test de Stroop, Digit span, Visual Object and Space Perception Battery, Luria motor sequences, Rey-Osterrieth complex figure)
  • Limbic functions: emotion recognition (Ekman test), apathy (Lille Apathy Rating Scale);
  • Impulsivity and decision-making (Iowa Gambling test).
Being tested
Video polysomnography
Keywords
REM Sleep Behavior Disorder, Parkinson's Disease, REM sleep without Atonia
Medical subject headings
REM Sleep Behavior Disorder, Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Video polysomnographyProcedure or surgery

    the main objective of our study is to longitudinally evaluate clinical and vPSG features of RBD, including measure of RSWA, in patients with PD-RBD, after three years from the diagnosis of RBD, in order to ascertain whether RBD features remain stable over time. The possible remission of RBD with the progression of PD would question indeed its reliability as prognostic bio-marker.

Study groups in NCT03047408
Study groupRoleWhat they receive
patients with PD-RBDExperimentalpatients with PD-RBD having already underwent vPSG, clinical and neuropsychological in clinical setting or in the study "RBHP 2013 DURIF " at least three years ago.
Receives: Procedure: Video polysomnography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. presence of REM sleep Behavior Disorder confirmed during the video polysomnography

    Measured: at day 0

Secondary outcomes (24)

  1. The REM sleep Behavior Disorder severity measured by the REM sleep Behavior Disorder scale

    Measured: at day 0

  2. The Unified Parkinson disease Rating scale score

    Measured: at day 0

  3. The behavioral disorders measured by the Ardouin Scale of Behavior in Parkinson's Disease score

    Measured: at day 0

  4. - The Orthostatic hypotension measured by the Scale for outcomes in PD- autonomic questionnaire

    Measured: at day 0

  5. The impulsivity measured by the Test of Kirby score

    Measured: at day 0

  6. The impulsivity measured by the Stop signal reaction time score

    Measured: at day 0

  7. The Hoehn and Yahr scale score

    Measured: at day 0

  8. The Non-motor symptoms Questionnaire score

    Measured: at day 0

  9. The Epworth sleepiness scale score

    Measured: at day 0

  10. The Urgency premeditation perseverance and sensation seeking test

    Measured: at day 0

  11. The Aggressive questionnaire score

    Measured: at day 0

  12. The Hospital Anxiety and Depression Rating Scale

    Measured: at day 0

  13. The dream content

    Measured: at day 0

  14. The Mini mental state examination score

    Measured: at day 1

  15. The California Verbal Learning Test score

    Measured: at day 1

  16. The fluency verbal test score

    Measured: at day 1

  17. The Modified Wisconsin Card Sorting Test

    Measured: at day 1

  18. The Stroop score

    Measured: at day 1

  19. The Empan test score

    Measured: at day 1

  20. The Visual Object and Space Perception Battery test score

    Measured: at day 1

  21. The Luria motor sequences

    Measured: at day 1

  22. The Rey-Osterrieth complex figure

    Measured: at day 1

  23. The Lille Apathy Rating Scale score

    Measured: at day 1

  24. The Iowa Gambling test score

    Measured: at day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2017 (estimated)
  2. Study startFeb 2017 (estimated)
  3. Primary completionApr 2019 (estimated)
  4. Study completionJun 2019 (estimated)

Resources

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
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03047408
Sponsor's protocol ID
CHU-300
Other IDs
2016-A01736-45
Status last verified
Feb 2017
First submitted
24 Jan 2017
Last updated
9 Feb 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Video polysomnography in people with REM Sleep Behavior Disorder and Parkinson's Disease, run by University Hospital, Clermont-Ferrand 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 5 inclusion and 5 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 9 Feb 2017. 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 Patrick LACARIN (0473751195, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

presence of REM sleep Behavior Disorder confirmed during the video polysomnography (time frame: at day 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03047408.

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 9 Feb 2017.

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