drugset / Trial / NCT03066518

Effect of Melatonin on Sleep Quality in Patients Dementia

NCT03066518

Phase 4 Completed 40 enrolled Hospital Universitario Dr. Jose E. Gonzalez
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Introduction: Patients with dementia may suffer from poor sleep quality. Disturbance in the metabolism melatonin may have a role in the pathogenesis of sleep-wake cycle alterations in dementia. Objective: To evaluate the efficacy of low dose exogenous melatonin in improving sleep quality. Design: A single-center randomized, double-blinded, placebo-controlled study carried out on outpatients with dementia and sleep alterations. Participants: The investigators calculated a 40 individuals aged 65 years or over with a diagnosis of mild-moderate dementia (Clinical Dementia Rating 1-2). Intervention: Patients were randomized to receive either 5 mg of melatonin or placebo every night for 8 weeks. Measurements: The primary outcome was sleep quality according to the Pittsburgh Sleep Quality Index (PSQI).

Timeline

Start
2016-01-15
Primary completion
2017-01-25
Completion
2017-01-25

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Melatonin Small molecule 5 mg Oral

Indications