Trial Outcomes & Findings for Melatonin for Circadian Sleep Disorders in the Blind (NCT NCT00911053)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

59 participants

Primary outcome timeframe

1 year

Results posted on

2019-11-27

Participant Flow

The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.

Participant milestones

Participant milestones
Measure	Baseline	Melatonin Subjects will be administered melatonin. Melatonin: Melatonin will be administered under FDA IND #26,318, doses between 0.025 mg and 20 mg.	Light Light: Subjects will be exposed to light.	Regular Sleep Schedule Regular Sleep Schedule: Subjects will maintain a regular sleep schedule of their choosing.	Longitudinal Monitoring Optional longitudinal study, an extension of the first study stage, for subjects whose rhythms are not clearly free-running.
Overall Study STARTED	0	0	0	0	0
Overall Study COMPLETED	0	0	0	0	0
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Melatonin for Circadian Sleep Disorders in the Blind

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 1 year

Population: The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.