Sleep Profiles in REM Sleep Behavior Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-07

Study Completion Date

2026-11-30

Brief Summary

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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 patients' quality of life and safety. One of the known causes of sleep disturbance is the impairment of the "circadian rhythm", or the human sleep/wake cycle. The purpose of this study is to examine the role of disruption of the circadian rhythm in the development of RBD.

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Detailed Description

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Conditions

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Rapid Eye Movement Sleep Behavior Disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Participants with RBD

Participants with REM Sleep Behavior Disorder

No interventions assigned to this group

Participants without RBD

Age- and gender-matched controls, without REM Sleep Behavior Disorder

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of RBD as assessed by the International Classification of Sleep Disorders (ICDS) diagnostic criteria within 3 years
2. 40 yrs of age

Exclusion Criteria

1. Other significant neurological disorder
2. Untreated significant sleep apnea and/or current sleep apnea symptoms as assessed by the clinical investigator
3. Co-existent restless legs syndrome (RLS), as assessed by the ICDS diagnostic criteria for RLS
4. Cognitive impairment as determined by the Montreal Cognitive Assessment (MoCA) score of ≤ 23
5. Presence of depression defined as the Beck Depression Inventory (BDI) score \>20
6. 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
7. Use of medications known to affect melatonin secretion, such as lithium, α- and β-adrenergic antagonists
8. Shift work, currently or within the prior 3 months
9. Travel through ≥ 2 time zones within 60 days prior to the screening

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes