Melatonin Studies of Totally Blind Children
|ClinicalTrials.gov Identifier: NCT00795236|
Recruitment Status : Unknown
Verified July 2011 by Oregon Health and Science University.
Recruitment status was: Recruiting
First Posted : November 21, 2008
Last Update Posted : July 18, 2011
|Condition or disease||Intervention/treatment|
|Sleep Disorder Blindness||Drug: Melatonin|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 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|
|Estimated Primary Completion Date :||November 2012|
|Estimated Study Completion Date :||November 2012|
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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00795236
|United States, Oregon|
|Oregon Health and Science University||Recruiting|
|3181 SW Sam Jackson Park Road, Oregon, United States, 97239|
|Contact: Amber Laurie 866-424-6060 email@example.com|
|Principal Investigator:||Alfred Lewy, MD, PhD||Oregon Health and Science University|