Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04886076

Sleep Profiles in REM Sleep Behavior Disorder

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Rapid Eye Movement Sleep Behavior Disorder Mental Disorders Nervous System Diseases Parasomnias REM Sleep Behavior Disorder REM Sleep Parasomnias Sleep Wake Disorders

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Circadian Amplitude

    Time frame: Study Day 17-18

    amplitude and area under the curve (AUC) of serum melatonin and clock gene expression

  2. 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

  3. Objective Daytime Sleepiness

    Time frame: Study Day 17

    MSLT (Multiple Sleep Latency Test) assessed via Polysomnography

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Circadian Rhythms Regulation in Pre-Manifest Synucleinopathies

Important dates

Study start
2018
Primary completion
2021
Study completion
2026
First posted
May 13, 2021
Registry last updated
Nov 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.