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NCT06868745
Effects of Melatonin Supplementation on Sleep Quality in Patients With Advanced Glaucoma
NA trial testing Experimental: melatonin treatment group in Glaucoma in 64 participants. Completed in 26 June 2024.
20 July 2023
Quick facts
| Lead sponsor | University of Sao Paulo |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | supportive care |
| Enrollment | 64 |
| Start date | 4 May 2022 |
| Primary completion | 20 July 2023 |
| Estimated completion | 26 June 2024 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Experimental: melatonin treatment group — full drug profile →
- Placebo comparator: placebo treatment group — full drug profile →
Conditions studied
- Glaucoma — all drugs for Glaucoma →
- Sleep Disturbance — all drugs for Sleep Disturbance →
- Circadian Rhythm — all drugs for Circadian Rhythm →
- Melatonin — all drugs for Melatonin →
Sponsor
University of Sao Paulo
Who can join
Adults 40 to 80, any sex, with Glaucoma or Sleep Disturbance. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Tryptophan metabolism in glaucomatous optic neuropathy: from metabolic dysregulation to therapeutic opportunities.
Wang N, Yan T, Sun H, Guo W. · · 2026 · PMID 42021335 · DOI 10.1186/s12967-026-08120-2
Verify or expand the search:
- PubMed search for NCT06868745
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06868745 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Sao Paulo
- Last refreshed: 11 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06868745.
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