Randomized Clinical Trial: Effects of Melatonin Supplementation on Sleep Quality in Patients With Advanced Glaucoma
Abstract
A prospective, randomized, parallel, crossover, double-blind therapeutic clinical trial was conducted in accordance with the principles of the Resolution nº 466/12 of the National Health Council and was approved by the Ethics and Research Committee of the Federal University of São Paulo, project CEP/UNIFESP n:1023/2020, CAAE: 36946620.9.0000.5505. Written informed consent was obtained from all participants. The study was conducted at the Glaucoma Division and the Department of Psychobiology at the Federal University of São Paulo - UNIFESP/EPM and at the Laser Vision Eye Hospital - Santos/SP between May/2022 and July/2023.
Conditions: Glaucoma, Sleep Disturbance, Circadian Rhythm, Melatonin, Actigraphy.
Primary outcome: Effects of Melatonin Replacement on Sleep Quality of Patients with Advanced Glaucoma.
Enrollment: 64 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 64 participants or records.
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