Sleep Profiles in REM Sleep Behavior Disorder

Mass General Brigham

Status: Active, not recruiting

Conditions: Rapid Eye Movement Sleep Behavior Disorder

Study type: Observational

Funder types: Other

Identifiers

NCT04886076

2018P000894

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

30 participants in 2 patient groups

Participants with RBD

Description:

Participants with REM Sleep Behavior Disorder

Participants without RBD

Description:

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