Effects of Melatonin Supplementation on Sleep Quality in Patients With Advanced Glaucoma

NCT06868745 | Completed

• 1 other identifier: 36946620.9.0000.5505
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

glaucoma; sleep disturbance; circadian rhythm; melatonin; actigraph

Outcome Measures

Primary Outcomes (1)

• Effects of Melatonin Replacement on Sleep Quality of Patients with Advanced Glaucoma

  To compare the quality of sleep in patients with advanced glaucoma after 30 days of melatonin 5 mg and 30 days of placebo. The comparison of efficacy between groups will be assessed based on the improvement in sleep quality between medications.

  From enrollment to the end of treatment in 2 months

Secondary Outcomes (4)

• Effects of Melatonin Replacement on Sleep Quality of Patients with Advanced Glaucoma

  From registration to the end of treatment in 2 months

• Effects of Melatonin Replacement on Sleep Quality of Patients with Advanced Glaucoma

  From registration to the end of treatment in 2 months

• Effects of Melatonin Replacement on Sleep Quality of Patients with Advanced Glaucoma

  From registration to the end of treatment in 2 months

• Effects of Melatonin Replacement on Sleep Quality of Patients with Advanced Glaucoma

  From registration to the end of treatment in 2 months

Study Arms (2)

melatonin treatment group

EXPERIMENTAL

Each participant received melatonin 5 mg and placebo for a period of 30 days

Drug: Experimental: melatonin treatment group; Drug: Placebo comparator: placebo treatment group

placebo treatment group

PLACEBO COMPARATOR

Each participant received melatonin 5 mg and placebo for a period of 30 days

Drug: Experimental: melatonin treatment group; Drug: Placebo comparator: placebo treatment group

Interventions

Experimental: melatonin treatment group DRUG

Each participant received melatonin 5 mg for a period of 30 days

melatonin treatment group; placebo treatment group

Placebo comparator: placebo treatment group DRUG

Each participant received placebo for a period of 30 days

melatonin treatment group; placebo treatment group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Primary Open-Angle Glaucoma: Must have a confirmed diagnosis of primary open-angle glaucoma.
• Cup-to-Disc Ratio \> 0.6: The ratio of cup to disc on optic disc imaging must be greater than 0.6.
• Visual Acuity ≥ 0.4 logMAR: Participants must have a visual acuity of 0.4 logMAR or better in the better eye.
• Age: Participants must be aged 40 to 80 years, inclusive.

You may not qualify if:

• Pregnancy: Female participants who are pregnant or planning to become pregnant during the study period.
• Current or Past Diagnosis of Depression: Participants with a current or past history of depression.
• Corneal or Retinal Diseases: History or active disease of the cornea or retina (e.g., diabetic retinopathy, macular degeneration).
• Shift Work: Participants who work night shifts or irregular hours.
• Travel Across Time Zones: Participants who have traveled across time zones in the last 30 days prior to enrollment.
• Diagnosed Obstructive Sleep Apnea: History of obstructive sleep apnea or a current diagnosis of the condition.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Casa

Santos, São Paulo, 11.075-340, Brazil

Location

MeSH Terms

Conditions

Glaucoma; Parasomnias

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: there is no
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A prospective, randomized, parallel, cross-over, and double-blind therapeutic-type clinical study was conducted at the Glaucoma Division and the Department of Psychobiology at the Federal University of São Paulo - UNIFESP/EPM and the Eye Hospital Visao Laser in Santos/SP. The study involved 64 patients, with an age range of over 40 and under 80 years old. All participants underwent a complete ophthalmological evaluation and completed questionnaires on sleep quality (PSQI-BR), the Epworth Sleepiness Scale, and the Vision Function Questionnaire (NEI VFQ-25). Each participant received either 5mg of melatonin or a placebo for 30 days at different times. During this period, they were assessed using actigraphy, questionnaires, and examinations on day 0 (before starting the medication) and on day 30. Afterward, the use of the medication was discontinued.

Study Record Dates

• First Submitted: January 25, 2025
• First Posted: March 11, 2025
• Study Start: May 4, 2022
• Primary Completion: July 20, 2023
• Study Completion: June 26, 2024
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: concluded
• Access Criteria: Word file by email

Locations

BR (1)