Status:
ACTIVE_NOT_RECRUITING
Sleep Profiles in REM Sleep Behavior Disorder
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Rapid Eye Movement Sleep Behavior Disorder
Eligibility:
All Genders
40+ years
Brief Summary
Rapid eye movement (REM) sleep behavior disorder (RBD) is a sleep disorder in which you act out dreams during REM sleep. Sleep disturbances are very common in RBD, where they negatively impact patient...
Eligibility Criteria
Inclusion
- Diagnosis of RBD as assessed by the International Classification of Sleep Disorders (ICDS) diagnostic criteria within 3 years
- 40 yrs of age
Exclusion
- Other significant neurological disorder
- Untreated significant sleep apnea and/or current sleep apnea symptoms as assessed by the clinical investigator
- Co-existent restless legs syndrome (RLS), as assessed by the ICDS diagnostic criteria for RLS
- Cognitive impairment as determined by the Montreal Cognitive Assessment (MoCA) score of ≤ 23
- Presence of depression defined as the Beck Depression Inventory (BDI) score \>20
- Use of tricyclic antidepressants, MAO inhibitors or selective serotonin reuptake inhibitors since they may induce/worsen RBD, unless on a stable dose of medication for at least 8 weeks
- Use of medications known to affect melatonin secretion, such as lithium, α- and β-adrenergic antagonists
- Shift work, currently or within the prior 3 months
- Travel through ≥ 2 time zones within 60 days prior to the screening
Key Trial Info
Start Date :
December 7 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04886076
Start Date
December 7 2018
End Date
November 1 2026
Last Update
November 5 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114