Sleep Disorders Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

For people with iRBD (a sleep behaviour disorder):

• People who have been diagnosed with isolated RBD (a sleep disorder where people act out their dreams), confirmed by a sleep study called a polysomnogram.
• People who are able to walk 50 metres on their own without using a walking aid such as a cane.
• People aged between 21 and 75 years.

For people joining as a healthy comparison (control) participant:

• People aged between 21 and 75 years.
• People who are able to walk 50 metres on their own without using a walking aid such as a cane or walker.

Who may not be able to join:

For people with iRBD:

• People who have been diagnosed with dementia, or whose assessment results suggest they may not have the capacity to give informed consent.
• People with a history of bone or muscle conditions that significantly affect movement in their arms or legs.
• People with other significant neurological (brain or nervous system) conditions that could affect their ability to take part or perform study tasks.
• People whose dream-acting behaviour appeared or clearly got worse after starting an antidepressant medication.
• People who already meet the criteria for Parkinson's disease, dementia with Lewy bodies, Multiple System Atrophy, Alzheimer's disease, or another neurodegenerative condition, or whose RBD has a known cause such as narcolepsy or medication.
• People with untreated sleep-disordered breathing (such as untreated sleep apnea).
• Women who are pregnant.
• People with certain additional conditions or circumstances that would prevent participation in the brain stimulation (TMS) part of the study — though these individuals may still be able to take part in other parts of the trial:
  • A history of seizures, epilepsy, stroke, multiple sclerosis, or traumatic brain injury.
  • A recent history of frequently fainting in response to the sight of blood, emotional stress, or sensory triggers.
  • Metal or magnetic devices inside the skull, such as a cochlear implant or deep brain stimulator.
  • A pacemaker or any other implanted medical device.
  • A history of surgery on the brain, heart, or blood vessels.
  • Unexplained recurring headaches, or a concussion within the last six months.
  • Severe hearing impairment.
  • Currently taking certain medications that affect brain plasticity testing, including haloperidol, prazosin, biperiden, dopamine-affecting drugs, NMDA receptor or calcium channel medications, benzodiazepines, lithium, lovastatin, or cannabis (confirm with trial site if unsure whether a medication applies).

For healthy comparison (control) participants:

• All of the same exclusion criteria listed above for the iRBD group.
• People who have a history of acting out dreams during sleep — whether reported by themselves or witnessed by a bed partner — in a way that might suggest iRBD.
• People with untreated sleep-disordered breathing.
• People who show signs of parkinsonism (movement difficulties linked to Parkinson's-like conditions) or any level of cognitive impairment, including mild cognitive impairment or dementia.
• People with an active nervous system condition, systemic illness, psychiatric condition, or who are taking medications that affect thinking, movement, mood, or the automatic functions of the body.

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