Rapid Eye Movement Sleep Behavior DisorderNCT04886076
Sleep Profiles in REM Sleep Behavior Disorder
An observational study of Rapid Eye Movement Sleep Behavior Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rapid Eye Movement Sleep Behavior Disorder
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2018to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Diagnosis of RBD as assessed by the International Classification of Sleep Disorders (ICDS) diagnostic criteria within 3 years
- 40 yrs of age
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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.
- Medical subject headings
- REM Sleep Behavior Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with RBD | Participants with REM Sleep Behavior Disorder | |
| Participants without RBD | Age- and gender-matched controls, without REM Sleep Behavior Disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circadian Amplitude
amplitude and area under the curve (AUC) of serum melatonin and clock gene expression
Measured: Study Day 17-18
REM Sleep Phenomena
REM (rapid eye movement) sleep duration, REM Index, and EMG (electromyographic) activity) assessed via overnight Polysomnography
Measured: Study Day 16-17
Objective Daytime Sleepiness
MSLT (Multiple Sleep Latency Test) assessed via Polysomnography
Measured: Study Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start7 Dec 2018
- Primary completion9 Sep 2021
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rapid Eye Movement Sleep Behavior DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandar Videnovic, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886076
- Sponsor's protocol ID
- 2018P000894
- Status last verified
- Nov 2025
- First submitted
- 12 Aug 2019
- Last updated
- 5 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circadian Rhythms Regulation in Pre-Manifest Synucleinopathies
- ClinicalTrials.gov ID
- NCT04886076
- Acronym / sponsor ID
- 2018P000894
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 7 Dec 2018 (actual)
- Primary completion
- 9 Sep 2021 (actual)
- Study completion
- Nov 2026 (estimated)
- First posted
- 13 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with RBD | – | –Participants with REM Sleep Behavior Disorder |
| Participants without RBD | – | –Age- and gender-matched controls, without REM Sleep Behavior Disorder |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Diagnosis of RBD as assessed by the International Classification of Sleep Disorders (ICDS) diagnostic criteria within 3 years
- 40 yrs of age
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rapid Eye Movement Sleep Behavior Disorder, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circadian Amplitude (time frame: Study Day 17-18). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2025.