Active — Not RecruitingNot Applicable

Sleep Profiles in REM Sleep Behavior Disorder

United States30 participantsStarted 2018-12-07

Plain-language 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.

Who can participate

Age range40 Years

SexALL

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Inclusion criteria

✓. Diagnosis of RBD as assessed by the International Classification of Sleep Disorders (ICDS) diagnostic criteria within 3 years
✓. 40 yrs of age

Exclusion criteria

✕. 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

What they're measuring

Circadian Amplitude

Timeframe: Study Day 17-18

REM Sleep Phenomena

Timeframe: Study Day 16-17

Objective Daytime Sleepiness

Timeframe: Study Day 17

Trial details

NCT IDNCT04886076

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-09-09

View on ClinicalTrials.gov More Rapid Eye Movement Sleep Behavior Disorder trials