NCT04886076

Active Not Recruiting

Sleep Profiles in REM Sleep Behavior Disorder

Massachusetts General Hospital Source

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Other study identifiers

Sponsor study identifier

2018P000894

Study Type

observational

Estimated enrollment

30

Locations

1 country

Sites

1

Timeline

Study Start

December 7, 2018

Actual (reported)

Primary Completion

September 9, 2021

Actual (reported)

Study Completion

November 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: active not recruiting
Estimated enrollment: 30 participants
Study completion date: November 2026
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
December 7, 2018
Actual (reported)
First Submitted
August 12, 2019
Actual (reported)
First Posted
May 13, 2021
Actual (reported)
Primary Completion
September 9, 2021
Actual (reported)
Study Completion
November 2026
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: November 5, 2025
Status Verified: November 2025
Last Update Submitted: November 4, 2025

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

Age40 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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

Sponsors & Collaborators

Massachusetts General Hospital
Otherlead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

MeSH Terms

Conditions

REM Sleep Behavior Disorder

Condition Hierarchy (Ancestors)

REM Sleep ParasomniasParasomniasSleep Wake DisordersNervous System DiseasesMental 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

Actual (reported)

Primary Completion

September 9, 2021

Actual (reported)

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PREdictive Risk Factors of Conversion Into Idiopathic RBD. Italian Study

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NCT06996652

An Exploratory Study of the Potential for Rational Immune System Manipulation to Prevent Emergence of Synucleinopathy Manifestations in Persons With REM Sleep Behavior Disorder (RBD)

Phase 2Recruiting

NCT03595475

Prodromal Markers of First-degree Relatives of Patients With Psychiatric Disorders Comorbid With RBD

Completed

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

Contact the study team to confirm eligibility.

Study Completion

November 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated

November 5, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

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Registry identifier: NCT04886076
Data provider: ClinicalTrials.gov
Source updated: 2025-11-05
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:38:34 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Study Arms (2)

Participants with RBD

Participants without RBD

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations