Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:51 PM
Ignite Modification Date:
2025-12-24 @ 12:51 PM
NCT ID:
NCT06467461
Eligibility Criteria:
Inclusion Criteria:
Serotonergic REM sleep behavior (5-HT RBD) participants
Inclusion Criteria:
* 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
Inclusion Criteria:
* 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.
The following serotonergic medications will be included:
Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, and Sertraline
Exclusion Criteria:
Serotonergic REM sleep behavior (5-HT RBD) participants
Exclusion Criteria:
* 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
* MRI exclusion criteria for 7T scans: presence of any metallic clip(s) or implantable medical devices (e.g., heart valve, aneurysm clip, coils or surgery, renal or aortic clips, shunts, stents or stent grafts, metal mesh/coil implants, neurostimulator, insulin pump, IVC filter, etc.).
* 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
Exclusion Criteria: same exclusion criteria as 5-HT RBD group, plus the following:
* History of dream enactment that may suggest RBD
* Increased REM motor tone (REM atonia index \> 0.10) on PSG suggestive of RBD
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06467461
Study Brief:
Protocol Section:
NCT06467461