Actively Recruiting
Identification of Prodromal Neurodegeneration in Serotonergic-Induced REM Sleep Behavior Disorder
Led by University of Minnesota · Updated on 2025-07-08
60
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the early signs of neurodegeneration in people who experience REM sleep behavior disorder (RBD) linked to the use of serotonergic antidepressants. This study aims to detect abnormal alpha-synuclein protein deposits, brainstem neurodegeneration, and speech changes in individuals with 5-HT RBD compared to matched controls without RBD but using similar medications. The research seeks to understand how these factors relate to each other and to prodromal signs of dementia with Lewy bodies. Participants will undergo skin biopsies to check for alpha-synuclein pathology, ultra-high field 7T MRI scans to examine brainstem regions controlling REM sleep, and speech tests to measure changes in voice pitch and articulation. The study includes a baseline assessment and a follow-up visit approximately 24 months later to track changes over time. Both groups, 5-HT RBD patients and controls on serotonergic medications without RBD, will be included. During the study, participants will have biopsies, MRI scans, and speech testing at both the start and after 24 months. Researchers will measure protein deposits in skin samples, brain neuromelanin signal intensity, and speech characteristics such as pitch variability and speed of articulatory changes. The study lasts about two years with two major evaluation points to observe disease progression and correlations among biological and neurological markers.
CONDITIONS
Brief Title
Identification of Prodromal Neurodegeneration in Serotonergic-Induced REM Sleep Behavior Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Diagnosis of polysomnogram-confirmed REM sleep behavior disorder with dream enactment
- Dream enactment began within 2 months of starting a serotonergic antidepressant medication
- Control participants matched by age and sex, on serotonergic medication for at least 6 months without dream enactment
- Use of one of the following serotonergic medications: Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, or Sertraline
You will not qualify if you...
- Younger than 18 or older than 75 years
- Diagnosed with Parkinson's disease, dementia with Lewy bodies, multiple system atrophy, pure autonomic failure, Alzheimer's disease, or other neurodegenerative disorder
- Other known causes of REM sleep behavior disorder such as narcolepsy
- Untreated obstructive sleep apnea, obesity hypoventilation, central sleep apnea, or other sleep disordered breathing
- History of speech disorders like dysarthria or aphasia interfering with speech assessment
- Reduced capacity to consent
- MRI exclusion criteria including metallic clips or implantable devices
- History of allergic reaction to local anesthesia like xylocaine
- Pregnant women
- For control participants only: history of dream enactment or increased REM motor tone suggestive of RBD on polysomnogram
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline and 24 months (+/- 3 months)
Participants undergo diagnostic tests including skin biopsy, speech testing, and 7T MRI to assess signs of neurodegeneration related to serotonergic-induced REM sleep behavior disorder.
2 visits (in-person)
Duration - 24 months (+/- 3 months)
Participants are monitored over 24 months to observe changes in biomarkers and clinical features associated with neurodegeneration.
2 visits (in-person)
Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
J
Joy Schmidt
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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