drugset / Trial / NCT00688935
Young Blind Child Melatonin Treatment Study
Non-randomizedSingle-groupSingle-blindDiagnostic
Summary
The primary goal of this study is to identify the presence of desynchronized circadian rhythms in 25 children by measuring melatonin secretion in serial blood or saliva samples, and to rule out any primary sleep disorders.
Timeline
- Start
- 2005-01
- Primary completion
- 2015-05
- Completion
- 2015-05
Publications
- Background Palm L, Blennow G, Wetterberg L. Long-term melatonin treatment in blind children and young adults with circadian sleep-wake disturbances. Dev Med Child Neurol. 1997 May;39(5):319-25. doi: 10.1111/j.1469-8749.1997.tb07438.x.
- Background Sack RL, Lewy AJ, Blood ML, Keith LD, Nakagawa H. Circadian rhythm abnormalities in totally blind people: incidence and clinical significance. J Clin Endocrinol Metab. 1992 Jul;75(1):127-34. doi: 10.1210/jcem.75.1.1619000.
- Background Tzischinsky O, Skene D, Epstein R, Lavie P. Circadian rhythms in 6-sulphatoxymelatonin and nocturnal sleep in blind children. Chronobiol Int. 1991;8(3):168-75. doi: 10.3109/07420529109063923.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Melatonin | Small molecule | 0.1 mg | — |
| Subject | Melatonin | Small molecule | 3 mg | — |