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Study on Serotonergic-Induced REM Sleep Behavior Disorder

This study is looking for people aged 18 to 75 who have REM sleep behavior disorder (RBD) that started shortly after taking a serotonergic antidepressant medication. The goal is to understand if this type of RBD is an early sign of conditions like Dementia With Lewy Bodies or Parkinson's Disease. You would undergo a skin biopsy to check for a protein called alpha-synuclein, speech testing, and a special type of MRI scan (7T MRI) to look at your brain. Researchers will measure changes in alpha-synuclein in your skin, brain signals, and speech over 24 months. The study is currently unclear about its recruitment status and plans to enroll 60 participants.

Study design
This is an interventional study planning to enroll 60 participants. It is not specified if it is randomized or blinded.
What's involved
You would undergo a skin biopsy, speech testing, and an ultra-high field 7T MRI at the beginning of the study and again after 24 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 months after the initial assessments.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06467461

5-HT RBD REM Sleep Behavior Disorder

Active, Not Recruiting
NAAges 18–75InterventionalBasic science
University of Minnesota
~66 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:Skin biopsySpeech testingUltra high field 7T MRI

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phosphorylated alpha synuclein deposits on skin biopsy
Measured over time point 1 (baseline) and time point 2 (24 months, +/- 3 months)
+2 more outcomes measured

Conditions

Dementia With Lewy Bodies
Parkinson Disease
REM Sleep Behavior Disorder

Explore related trials

Lewy Body DementiaParkinson DiseaseREM sleep behavior disorder

NCT06467461

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Minnesota

    Minneapolis, Minnesotano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Michael Howell, MD · PRINCIPAL_INVESTIGATOR · University of Minnesota

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Diagnosis of polysomnogram-confirmed RBD with history of dream enactment or clear dream enactment visualized on video from polysomnogram.
History of dream enactment began shortly after (less than 2 months) starting a serotonergic antidepressant medication. Control Participants
Age (±3 years) and sex matched to participants with 5-HT RBD
On serotonergic medication for at least 6 months without history of dream enactment.

Exclusion

Younger than 18
Older than 75
Meet criteria for Parkinson's disease, dementia with Lewy bodies, Multiple System Atrophy, Pure Autonomic Failure, Alzheimer's disease, other diagnosed neurodegenerative disorder, or other known cause of RBD (e.g. narcolepsy)
Untreated obstructive sleep apnea, obesity hypoventilation, central sleep apnea or other sleep disordered breathing
History of dysarthria, aphasia or other condition which could interfere with speech assessment
Reduced capacity to consent
History of allergic response to xylocaine or other local anesthesia
Pregnant women will be excluded due to unknown risk of MRI on developing fetus Control Participants
History of dream enactment that may suggest RBD
Increased REM motor tone (REM atonia index \> 0.10) on PSG suggestive of RBD

What this trial measures

  • Phosphorylated alpha synuclein deposits on skin biopsytime point 1 (baseline) and time point 2 (24 months, +/- 3 months)

    Incidence (positive or negative) of phosphorylated alpha synuclein deposits. Indicating direct histopathological confirmation of underlying alpha-synuclein degeneration in 5-HT RBD in a cohort of people with 5-HT RBD and matched controls (taking SSRIs but without RBD).

  • Neuromelanin signal intensity in the Subcoeruleus/Coeruleus Complextime point 1 (baseline) and time point 2 (24 months, +/- 3 months)

    Examination of the pontine region of the coeruleus/subcoeruleus complex for evidence of neurodegeneration as well as segment and parcellate REM sleep related neuronal structures.

  • Monopitch as measured by fundamental frequency variability.time point 1 (baseline) and time point 2 (24 months, +/- 3 months)

    Participants' voice and speech quality will be examined for synucleinopathy syndrome. The focus on speech function is designed to detect subtle brainstem deficits prior to more overt manifestations of cortical dementia.