GlaucomaNCT06868745
Effects of Melatonin Supplementation on Sleep Quality in Patients With Advanced Glaucoma
A study testing Experimental: melatonin treatment group in people with Glaucoma and Sleep Disturbance, run by University of Sao Paulo at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Glaucoma, Sleep Disturbance, Circadian Rhythm
- What is being tested?
- Experimental: melatonin treatment group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteBrazil
- Study dates
- 4 May 2022to 26 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial: Effects of Melatonin Supplementation on Sleep Quality in Patients With Advanced Glaucoma
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.
Read the 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.
- Conditions
- Glaucoma, Sleep Disturbance, Circadian Rhythm, Melatonin, Actigraphy
- Being tested
- Experimental: melatonin treatment group, Placebo comparator: placebo treatment group
- Keywords
- glaucoma, sleep disturbance, circadian rhythm, melatonin, actigraph
- Medical subject headings
- Glaucoma, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: melatonin treatment groupDrug
Each participant received melatonin 5 mg for a period of 30 days
Placebo comparator: placebo treatment groupDrug
Each participant received placebo for a period of 30 days
| Study group | Role | What they receive |
|---|---|---|
| melatonin treatment group | Experimental | Each participant received melatonin 5 mg and placebo for a period of 30 days Receives: 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 Receives: Drug: Experimental: melatonin treatment group; Drug: Placebo comparator: placebo treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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;
Measured: From registration to the end of treatment in 2 months
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, 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.
Measured: From registration to the end of treatment in 2 months
Effects of Melatonin Replacement on Sleep Quality of Patients with Advanced Glaucoma
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;
Measured: From registration to the end of treatment in 2 months
Effects of Melatonin Replacement on Sleep Quality of Patients with Advanced Glaucoma
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.
Measured: From registration to the end of treatment in 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start4 May 2022
- Primary completion20 Jul 2023
- Study completion26 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Priscilla Fernandes Nogueira, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868745
- Sponsor's protocol ID
- 36946620.9.0000.5505
- Status last verified
- Mar 2025
- First submitted
- 25 Jan 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD used in the publication of the results
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial: Effects of Melatonin Supplementation on Sleep Quality in Patients With Advanced Glaucoma
- ClinicalTrials.gov ID
- NCT06868745
- Acronym / sponsor ID
- 36946620.9.0000.5505
- Conditions
- Glaucoma, Sleep Disturbance, Circadian Rhythm, Melatonin, Actigraphy
- Keywords
- glaucoma, sleep disturbance, circadian rhythm, melatonin, actigraph
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 4 May 2022 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| melatonin treatment group | Experimental | Drug: Experimental: melatonin treatment group, Drug: Placebo comparator: placebo treatment groupEach participant received melatonin 5 mg and placebo for a period of 30 days |
| placebo treatment group | Placebo comparator | Drug: Experimental: melatonin treatment group, Drug: Placebo comparator: placebo treatment groupEach participant received melatonin 5 mg and placebo for a period of 30 days |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: melatonin treatment groupEach participant received melatonin 5 mg for a period of 30 days | Drug | melatonin treatment group, placebo treatment group |
| Placebo comparator: placebo treatment groupEach participant received placebo for a period of 30 days | Drug | melatonin treatment group, placebo treatment group |
Primary outcome
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.
4 secondary outcomes
Effects of Melatonin Replacement on Sleep Quality of Patients with Advanced Glaucoma
Time frame: 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
Effects of Melatonin Replacement on Sleep Quality of Patients with Advanced Glaucoma
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: Yes. IPD used in the publication of the results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: melatonin treatment group in people with Glaucoma and Sleep Disturbance, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of Melatonin Replacement on Sleep Quality of Patients with Advanced Glaucoma (time frame: From enrollment to the end of treatment in 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.