Sleep Profiles in REM Sleep Behavior Disorder

Overview

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.

Full Title of Study: “Circadian Rhythms Regulation in Pre-Manifest Synucleinopathies”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: December 2021

Arms, Groups and Cohorts

  • Participants with RBD
    • Participants with REM Sleep Behavior Disorder
  • Participants without RBD
    • Age- and gender-matched controls, without REM Sleep Behavior Disorder

Clinical Trial Outcome Measures

Primary Measures

  • Circadian Amplitude
    • Time Frame: Study Day 17-18
    • amplitude and area under the curve (AUC) of serum melatonin and clock gene expression
  • REM Sleep Phenomena
    • Time Frame: Study Day 16-17
    • REM (rapid eye movement) sleep duration, REM Index, and EMG (electromyographic) activity) assessed via overnight Polysomnography
  • Objective Daytime Sleepiness
    • Time Frame: Study Day 17
    • MSLT (Multiple Sleep Latency Test) assessed via Polysomnography

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Massachusetts General Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Aleksandar Videnovic, MD, Principal Investigator – Massachusetts General Hospital
  • Overall Contact(s)
    • Aleksandar Videnovic, M.D., (617) 724-3837, avidenovic@mgh.harvard.edu

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