This trial is active, not recruiting.

Condition blindness
Treatment melatonin
Sponsor National Eye Institute (NEI)
Start date March 2007
End date July 2013
Trial size 200 participants
Trial identifier NCT00686907, 9R01 EY018312-09A1, eIRB 1029


The primary two foci of this five-year study will be to assess inter-individual variability in the timing of the body clock of blind individuals, and to optimize the melatonin dosing regimen for synchronizing body clocks of blind individuals to the 24-hour day.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking single blind (subject)
Primary purpose treatment
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).

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria: - blindness for at least one year, verified by an ophthalmologic exam - ability to comply with the requirements of the experimental protocol - competency to sign informed consent Exclusion Criteria: - abnormal heart, liver or kidney function - a current Axis I psychiatric or substance abuse disorder according to the DSM-IV Manual - external demands that limit the ability to maintain a regular schedule (e.g. night shift work) - pregnancy

Additional Information

Official title Melatonin for Circadian Sleep Disorders in the Blind
Principal investigator Alfred J Lewy, MD, PhD
Description The first part of the study is observational, in which the body clock rhythms of blind individuals are assessed for variability in patterns across subjects. The second part of the study involves a melatonin treatment (0.025-20 mg). The dose for each subject will be determined by the previous, observational data collected on the specifics of their individual body clock. The purpose of the intervention is to find an optimized dosing regimen and administration time to synchronize the body clocks of blind individuals, that seem to operate independent of the 24-hour environmental light/dark cycle, to the 24-hour day.
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by National Eye Institute (NEI).