Melatonin Studies of Totally Blind Children
Recruitment status was Recruiting
The purpose of this study is to learn more about abnormal body rhythms in blind boys and girls that keep them from falling asleep at bed-time or cause them difficulty staying alert during the day. The investigators hope to learn if there are any differences between the body rhythms of girls and boys. The investigators also want to investigate whether age or puberty have an effect on body rhythms.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Melatonin Studies in Young Blind Children and Adolescents|
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||November 2012|
|Estimated Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
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.
Subjects will be asked to collect saliva samples in their home hourly throughout the daytime, approximately every 2 weeks. Subjects may be monitored for up to a year, after which they will be discontinued from the study. If subjects are found to be naturally entrained to the 24-hour day, they will be monitored longitudinally for changes. Subjects will be discontinued after their monitoring period is over or after an entrained status has been confirmed. While no specific time commitment is required, we hope most subjects will participant for 4 months - 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: 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 firstname.lastname@example.org|
|Principal Investigator:||Alfred Lewy, MD, PhD||Oregon Health and Science University|