Sleep Profiles in REM Sleep Behavior Disorder

Circadian Rhythms Regulation in Pre-Manifest Synucleinopathies

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Rapid Eye Movement Sleep Behavior Disorder

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

This study will involve men and women of all ethnic groups. We will recruit adults ≥ 40 years of age.

Control participants will be age- (±5 years) and gender-matched to participants with RBD, have no diagnosis of RBD, and meet all other inclusion/inclusion criteria as the RBD group.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Participants with RBD; Participants with REM Sleep Behavior Disorder
Participants without RBD; Age- and gender-matched controls, without REM Sleep Behavior Disorder

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2018
• Primary Completion (Actual): September 9, 2021
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: August 12, 2019
• First Submitted That Met QC Criteria: May 12, 2021
• First Posted (Actual): May 13, 2021

Study Record Updates

• Last Update Posted (Estimated): November 5, 2025
• Last Update Submitted That Met QC Criteria: November 4, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Parasomnias; REM Sleep Parasomnias; REM Sleep Behavior Disorder
• Other Study ID Numbers: 2018P000894

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No