Ensayos clínicos

Overview

Información sobre este estudio

The primary aim of this study is to compare effectiveness of immediate versus extended-release melatonin as a supplement affecting the sleep cycle among patients with Parkinson’s disease as assessed by modified Mayo Sleep Questionnaire (MSQ).  The secondary aim is to evaluate the superiority and effect of immediate and extended-release melatonin versus not taking any melatonin on sleep cycle among patients with Parkinson’s disease as assessed by modified Mayo Sleep Questionnaire (MSQ).

Rapid eye movement (REM) sleep behavior disorder (RBD) is very common in patients with Parkinson disease and manifests with the loss of REM sleep atony, vigorous motor jerks, nocturnal vocalizations and dream enactment. Melatonin is commonly used as symptomatic management for RBD, but its efficacy is only supported by observational studies and a few controlled trials with relatively small number of participants. Melatonin may influence sleep cycle and affect clinical manifestations of RBD by decreasing muscle tonicity during REM sleep.  

Sleep normally cycles through REM and non-rapid eye movement (NREM) stages on average 4 to 6 times during the night. As the night progresses, fewer NREM stages occur, and the duration of REM sleep episodes increases. In a US-based randomized, crossover pharmacokinetic (PK) evaluation study,  an extended-release melatonin (ERM) exceeded the targeted sleep maintenance threshold for a median of 6.7 hours, compared with 3.7 hours with the immediate- release melatonin (IRM). We hypothesize that extended-release melatonin would be more helpful in regulating sleep cycle and affecting RBD, since REM density increases as night progresses. To our knowledge, no study that compares the efficacy of extended versus immediate-release melatonin on sleep cycle and its effect on RBD in patients with Parkinson disease has been done.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Sedes participantes de Mayo Clinic

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