Sleep Profiles in REM Sleep Behavior Disorder

NCT04886076 | Active Not Recruiting

• 1 other identifier: 2018P000894
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Rapid Eye Movement Sleep Behavior Disorder

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Participants with RBD

Participants with REM Sleep Behavior Disorder

Participants without RBD

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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

REM Sleep Behavior Disorder

Condition Hierarchy (Ancestors)

REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: May 13, 2021
• Study Start: December 7, 2018
• Primary Completion: September 9, 2021
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)