Sleep Profiles in REM Sleep Behavior Disorder

Rapid Eye Movement Sleep Behavior Disorder Clinical Trial

Official title:

Circadian Rhythms Regulation in Pre-Manifest Synucleinopathies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04886076
• Other study ID #: 2018P000894
• Status: Recruiting
• Start date: December 7, 2018
• Est. completion date: December 2021

Study information

• Verified date: May 2021
• Source: Massachusetts General Hospital
• Contact: Aleksandar Videnovic, M.D.
• Phone: (617) 724-3837
• Email: avidenovic[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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, a- and ß-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

Related Conditions & MeSH terms

• Mental Disorders
• Rapid Eye Movement Sleep Behavior Disorder
• REM Sleep Behavior Disorder

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

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