Sleep Disorders Trial, Recruiting NCT06467461 Sponsor: University of Minnesota Condition: Sleep Disorders
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Sleep Disorders Trial, Recruiting

NCT06467461
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

For people with serotonergic REM sleep behaviour disorder (5-HT RBD):

  • People who have been diagnosed with REM sleep behaviour disorder (RBD), confirmed by a sleep study, and who have a history of acting out their dreams (or this was captured on video during the sleep study).
  • People whose dream-enacting behaviour began within 2 months of starting a serotonergic antidepressant medication (one of: Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, or Sertraline).

For control participants (comparison group):

  • People who are within 3 years of age and of the same sex as a participant in the 5-HT RBD group.
  • People who have been taking one of the listed serotonergic medications for at least 6 months and have no history of acting out their dreams.

Who may not be able to join:

For people with 5-HT RBD (and also for control participants):

  • People younger than 18 or older than 75 years of age.
  • People who have been diagnosed with Parkinson's disease, dementia with Lewy bodies, Multiple System Atrophy, Pure Autonomic Failure, Alzheimer's disease, another neurodegenerative condition, or another known cause of RBD such as narcolepsy.
  • People with untreated sleep breathing problems, such as obstructive sleep apnoea or related conditions.
  • People with a history of speech difficulties (such as problems forming words or understanding language) that could affect speech-based assessments.
  • People who do not have full capacity to give informed consent to participate.
  • People with metal clips, implants, or certain medical devices in their body that are not safe for a high-strength (7 Tesla) MRI scan — for example, pacemakers, aneurysm clips, neurostimulators, insulin pumps, or similar devices.
  • People with a known allergic reaction to local anaesthetic medications such as xylocaine.
  • People who are pregnant, due to uncertainties about the effects of MRI on a developing baby.

Additional exclusions for control participants only:

  • People with any history of acting out their dreams in a way that might suggest RBD.
  • People whose sleep study results show a pattern of muscle activity during sleep that may be suggestive of RBD (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Michael Howell, MD, University of Minnesota

Phone: (612) 624 -1456

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
8 February 2024
Est. completion
1 December 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Phosphorylated alpha synuclein deposits on skin biopsy; Neuromelanin signal intensity in the Subcoeruleus/Coeruleus Complex; Monopitch as measured by fundamental frequency variability.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov