Sleep Profiles in REM Sleep Behavior Disorder

Circadian Rhythms Regulation in Pre-Manifest Synucleinopathies

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04886076

Enrollment

Registered

2021-05-13

Start date

2018-12-07

Completion date

2026-11-30

Last updated

2025-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rapid Eye Movement Sleep Behavior Disorder

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Outcome results