Blind Adult Melatonin Treatment Study
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|ClinicalTrials.gov Identifier: NCT00686907|
Recruitment Status : Unknown
Verified October 2012 by Alfred Lewy, National Eye Institute (NEI).
Recruitment status was: Active, not recruiting
First Posted : May 30, 2008
Last Update Posted : October 24, 2012
|Condition or disease||Intervention/treatment||Phase|
|Blindness||Drug: Melatonin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Melatonin for Circadian Sleep Disorders in the Blind|
|Study Start Date :||March 2007|
|Estimated Primary Completion Date :||July 2013|
|Estimated Study Completion Date :||July 2013|
Melatonin dosing regimen to determine the optimal dose and administration time to synchronize the circadian rhythms of blind individuals to the 24-hour day.
Dose range: 0.01 mg - 20 mg, daily, up to 5 years (based on each subject's circadian rhythms and response to the dose).
- Circadian phase marker, as measured by the levels of melatonin in serial salivary and/or plasma samples [ Time Frame: Longitudinal study, up to 5 years ]
- Actigraph watch data as a means to see how melatonin treatment affects the subjects sleep/activity patterns. [ Time Frame: Longitudinal study, up to 5 years ]
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): NCT00686907
|United States, Oregon|
|Sleep and Mood Disorders Lab, Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Alfred J Lewy, MD, PhD||Oregon Health and Science University|