Effects of Melatonin Supplementation on Sleep Quality in Patients with Advanced Glaucoma
Randomized Clinical Trial: Effects of Melatonin Supplementation on Sleep Quality in Patients with Advanced Glaucoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study included 64 patients with a diagnosis of advanced primary open-angle glaucoma in both eyes.
Patients were classified as glaucoma cases if they had at least 3 repeatable, consecutive, abnormal visual field test results, defined as a pattern standard deviation (PSD) outside the 95% normal confidence limits or a Glaucoma Hemifield Test (GHT) result outside normal limits matching the appearance of the optic disc, presenting a Mean deviation of <-12.00 dB in the better eye(7,14,17), according to the Hoddap-Parish-Anderson classification for glaucoma severity, using the SITA-Standard strategy, with no involvement of the fixation region (absence of statistically significant points in the central 5º for both total and pattern deviation).
Patients were considered as glaucomatous if they had signs of glaucomatous optic neuropathy based on optic disc stereophotographs. Evidence of glaucomatous damage to the optic disc nerve was considered if they had RNFL defects or localized or diffuse neuroretinal rim loss. There were 32 participants in the melatonin group and 32 in the placebo group. The age range of the volunteers was over 40 years and under 80 years.
Subjects were excluded if they were younger than 40 or older than 80 years; best-corrected visual acuity of less than 0.4 logMAR; Patients who work at night or recently traveled across time zones, use topical or systemic medications that could disrupt circadian rhythms, for example Benzodiazepines, Non-benzodiazepines (hypnotics), Sedative antidepressants, Melatonin and melatonin agonists, patients with previously defined obstructive sleep apnea or other disorders such as depression and insomnia were excluded. Only patients with an open angle on gonioscopy were included in our study.
Each participant received melatonin 5 mg and placebo for a period of 30 days at different time points. The packages were identical, each labeled with the letters F and I. Only the supervisor Dr. Augusto Paranhos Junior, had knowledge of which package contained the original drug. Additionally, the pills within the packages were identical and supplied by the same researcher, who was not informed about the significance of the letters on the packaging.
On day 0 (D0 - before starting the medication), subjects completed the Pittsburgh Sleep Quality Index (PSQI) and the Epworth Sleepiness Scale (ESS) to assess subjective sleep quality and daytime sleepiness, respectively. At D0, they also completed the 25-Item National Eye Institute Visual Function Questionnaire (NEI VFQ-25). The 24-hour daily profile of sleep parameters was assessed on a single night by actigraphy.
Questionnaires and actigraphy assessments were carried out, 30 days after each medication and in the wash out interval 7 days discontinuing the use of the medication.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Sao Paulo
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Santos, Sao Paulo, Brazil, 11.075-340
- Casa
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: melatonin treatment group
Each participant received melatonin 5 mg and placebo for a period of 30 days
|
Each participant received melatonin 5 mg for a period of 30 days
Each participant received placebo for a period of 30 days
|
|
Placebo Comparator: placebo treatment group
Each participant received melatonin 5 mg and placebo for a period of 30 days
|
Each participant received melatonin 5 mg for a period of 30 days
Each participant received placebo for a period of 30 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effects of Melatonin Replacement on Sleep Quality of Patients with Advanced Glaucoma
Time Frame: From enrollment to the end of treatment in 2 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effects of Melatonin Replacement on Sleep Quality of Patients with Advanced Glaucoma
Time Frame: From registration to the end of treatment in 2 months
|
To compare the effects on sleep quality after using melatonin 5 mg and placebo.
The effects on sleep quality will be measured by the following assessments: questionnaire (Pittsburgh Sleep Quality Index).
Sleep quality is measured on a 7-level scale, with the last level being the worst rating;
|
From registration to the end of treatment in 2 months
|
|
Effects of Melatonin Replacement on Sleep Quality of Patients with Advanced Glaucoma
Time Frame: From registration to the end of treatment in 2 months
|
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, using the actigraph, which will analyze the total sleep time through minutes slept, between the groups, the longer the time slept, the better quality of sleep, and also analyzes the number of awakenings, how many times during sleep the patient wakes up, the greater the number of awakenings, the worse the quality of sleep.
|
From registration to the end of treatment in 2 months
|
|
Effects of Melatonin Replacement on Sleep Quality of Patients with Advanced Glaucoma
Time Frame: From registration to the end of treatment in 2 months
|
To compare the effects on sleep quality after using melatonin 5 mg and placebo.
The effects on sleep quality will be measured by the following assessments: questionnaire, Epworth Sleepiness Scale, level of excessive sleepiness is measured on 8 levels, with the last level being the worst rating;
|
From registration to the end of treatment in 2 months
|
|
Effects of Melatonin Replacement on Sleep Quality of Patients with Advanced Glaucoma
Time Frame: From registration to the end of treatment in 2 months
|
To compare the effects on sleep quality after using melatonin 5 mg and placebo.
The effects on sleep quality will be measured by the following assessments: questionnaire, 25-Item National Eye Institute Visual Function Questionnaire, quality of life is measured on 25 levels, with the last level being the best rating.
|
From registration to the end of treatment in 2 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 36946620.9.0000.5505
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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