Melatonin Studies of Totally Blind Children
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|ClinicalTrials.gov Identifier: NCT00795236|
Recruitment Status : Terminated (Unique provision in the American Recovery and Reinvestment Act prevented approval of second year no-cost-extension in which completion of analyses were planned.)
First Posted : November 21, 2008
Results First Posted : November 27, 2019
Last Update Posted : November 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sleep Disorder Blindness||Drug: Melatonin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Melatonin Studies in Young Blind Children and Adolescents|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
No Intervention: Observational
Observe to determine free-running versus entrained status.
Subjects with free-running rhythms will take melatonin.
One 0.5 mg tablet of melatonin will be taken by subjects who are free-running and willing to enter the intervention phase of the study. These subjects will take melatonin until entrainment status is confirmed or throughout the duration of the study.
- To Test for a Proportional Gender Difference in Circadian Status (Free-running Versus Entrained) in Blind Children and in Adolescents, a Chi-square Test of Significance Will be Used for Each Age Group. [ Time Frame: Approximately 1 year ]
- To Test for a Proportional Difference in Circadian Status (Free-running Versus Entrained) Between Pre and Post- Pubertal Males in Blind Boys and Young Men, a Chi-square Test of Significance Will be Used for Each Age Group. [ Time Frame: Approximately 1 year ]
- To Determine the Efficacy of Melatonin Treatment in Entraining Blind Free-running Children and Young Adults, a Binomial Test Will be Used. [ Time Frame: Approximately 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00795236
|United States, Oregon|
|Oregon Health and Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Alfred Lewy, MD, PhD||Oregon Health and Science University|