REM Sleep Behavior DisorderALICENCT03072940
Brain Imaging in the Idiopathic REM Sleep Behavior Disorder (ALICE)
An observational study of REM Sleep Behavior Disorder and Healthy, run by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil at 1 site in France.
Trial summary
Idiopathic rapid eye movement sleep behavior disorder (iRBD) is characterized by nocturnal violence, increased muscle tone during REM sleep and the lack of any other neurological disease. However, iRBD can precede parkinsonism and dementia by several years. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- REM Sleep Behavior Disorder, Healthy
- What is being tested?
- Clinical investigations
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Dec 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- idiopathic RBD (criteria of the international classification of sleep disorders-3)
- For healthy controls : no neurologic or psychiatric disorder
Who cannot join
- Contraindication to MRI
- Do not speak French
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 3 T Multimodal MRI in Idiopathic RBD
Idiopathic rapid eye movement sleep behavior disorder (iRBD) is characterized by nocturnal violence, increased muscle tone during REM sleep and the lack of any other neurological disease. However, iRBD can precede parkinsonism and dementia by several years. The causes of the loss of muscle atonia during REM sleep in these patients are unclear. Using 3 T MRI and neuromelanin- sensitive sequences, the signal intensity was previously found to be reduce in the locus coeruleus/subcoeruleus area of patients with Parkinson's disease and RBD. Here, the investigators aimed at studying the integrity of the locus coeruleus/ subcoeruleus complex with neuromelanin-sensitive imaging in 21 patients with iRBD and compared the results with those from 21 age- and gender-matched healthy volunteers. All subjects will undergo a clinical examination, motor, cognitive, autonomous, psychological, olfactory and color vision tests, and rapid eye movement sleep characterization using video-polysomnography and 3 T magnetic resonance imaging.
- Conditions
- REM Sleep Behavior Disorder, Healthy
- Being tested
- Clinical investigations
- Medical subject headings
- REM Sleep Behavior Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical investigationsOther
Clinical examination, motor, cognitive, autonomous, psychological, olfactory and color vision tests, and rapid eye movement sleep characterization using video-polysomnography and 3 T magnetic resonance imaging
| Study group | Role | What they receive |
|---|---|---|
| Patients with idiopathic RBD | Not described Receives: Other: Clinical investigations | |
| Healthy volunteers | Not described Receives: Other: Clinical investigations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signal in the subcoeruleus/coeruleus complex
Brain imaging signal in the subcoeruleus/coeruleus complex in 3T multimodal MRI, using neuromelanin-sensitive sequence
Measured: 24h
Secondary outcomes (5)
Substantia nigra quantity
size of the substantia nigra
Measured: 24h
Quality of Sleep
Measures in videopolysomnography of efficiency of sleep
Measured: 24h
Cognition
Cognition status (MoCA test)
Measured: 24h
Olfactory function
Olfactory function (sniff test)
Measured: 24h
Color vision
Color vision function
Measured: 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study startFeb 2014
- Primary completionDec 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for REM Sleep Behavior DisorderStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
- Sponsor type
- University, hospital or other
- Collaborators
- NRJ Foundation - Institute of France, National Research Agency, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072940
- Sponsor's protocol ID
- ADOREPS_7
- Acronym
- ALICE
- Status last verified
- Mar 2017
- First submitted
- 28 Feb 2017
- Last updated
- 9 Mar 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ehrminger M, Latimier A, Pyatigorskaya N, Garcia-Lorenzo D, Leu-Semenescu S, Vidailhet M, Lehericy S, Arnulf I. The coeruleus/subcoeruleus complex in idiopathic rapid eye movement sleep behaviour disorder. Brain. 2016 Apr;139(Pt 4):1180-8. doi: 10.1093/brain/aww006. Epub 2016 Feb 26.
PubMed 26920675
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3 T Multimodal MRI in Idiopathic RBD
- ClinicalTrials.gov ID
- NCT03072940
- Acronym / sponsor ID
- ALICE / ADOREPS_7
- Conditions
- REM Sleep Behavior Disorder, Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le SommeilUniversity, hospital or other
- Collaborators
- NRJ Foundation - Institute of France, National Research Agency, France
- Study start
- Feb 2014 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Mar 2017 (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.
Idiopathic rapid eye movement sleep behavior disorder (iRBD) is characterized by nocturnal violence, increased muscle tone during REM sleep and the lack of any other neurological disease. However, iRBD can precede parkinsonism and dementia by several years. The causes of the loss of muscle atonia during REM sleep in these patients are unclear. Using 3 T MRI and neuromelanin- sensitive sequences, the signal intensity was previously found to be reduce in the locus coeruleus/subcoeruleus area of patients with Parkinson's disease and RBD. Here, the investigators aimed at studying the integrity of the locus coeruleus/ subcoeruleus complex with neuromelanin-sensitive imaging in 21 patients with iRBD and compared the results with those from 21 age- and gender-matched healthy volunteers. All subjects will undergo a clinical examination, motor, cognitive, autonomous, psychological, olfactory and color vision tests, and rapid eye movement sleep characterization using video-polysomnography and 3 T magnetic resonance imaging.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with idiopathic RBD | – | Other: Clinical investigations |
| Healthy volunteers | – | Other: Clinical investigations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- idiopathic RBD (criteria of the international classification of sleep disorders-3)
- For healthy controls : no neurologic or psychiatric disorder
Key exclusion criteria (2 listed)
- Contraindication to MRI
- Do not speak French
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 |
|---|---|---|
| Clinical investigationsClinical examination, motor, cognitive, autonomous, psychological, olfactory and color vision tests, and rapid eye movement sleep characterization using video-polysomnography and 3 T magnetic resonance imaging | Other | Healthy volunteers, Patients with idiopathic RBD |
Primary outcome
Signal in the subcoeruleus/coeruleus complex
Time frame: 24h
Brain imaging signal in the subcoeruleus/coeruleus complex in 3T multimodal MRI, using neuromelanin-sensitive sequence
5 secondary outcomes
Substantia nigra quantity
Time frame: 24h
Quality of Sleep
Time frame: 24h
Cognition
Time frame: 24h
Olfactory function
Time frame: 24h
Color vision
Time frame: 24h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Results publication: PubMed 26920675Ehrminger M, Latimier A, Pyatigorskaya N, Garcia-Lorenzo D, Leu-Semenescu S, Vidailhet M, Lehericy S, Arnulf I. The coeruleus/subcoeruleus complex in idiopathic rapid eye movement sleep behaviour disorder. Brain. 2016 Apr;139(Pt 4):1180-8. doi: 10.1093/brain/aww006. Epub 2016 Feb 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 REM Sleep Behavior Disorder and Healthy, run by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil 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 2 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: finished, as of the sponsor's last update on 9 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Signal in the subcoeruleus/coeruleus complex (time frame: 24h). 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 NCT03072940, which also lists 1 linked publication.
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 Mar 2017.