NCT06868745Completed
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
Source: ClinicalTrials.gov · Last updated 11 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 64 (actual)
- First submitted
- 25 Jan 2025
- Start date
- 4 May 2022
- Primary completion date
- 20 Jul 2023
- Lead sponsor
- University of Sao Paulo
- Diseases
- Glaucoma
- NCT number
- NCT06868745
What you commit to
- Study type: Interventional
- Participants enrolled: 64
- From 4 May 2022 to the primary completion date, 20 Jul 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Travel Across Time Zones: Participants who have traveled across time zones in the last 30 days prior to enrollment.
Other illness
- 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).
- Diagnosed Obstructive Sleep Apnea: History of obstructive sleep apnea or a current diagnosis of the condition.
Other
- Pregnancy: Female participants who are pregnant or planning to become pregnant during the study period.
- Shift Work: Participants who work night shifts or irregular hours.
Who the study is looking for
- 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.
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Casa Coordinator of this site? Confirm its status | Santos | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.