NCT00911053

Melatonin for Circadian Sleep Disorders in the Blind

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This research project consists of a three part study with five embedded sub studies. The first study phase identifies "body rhythms" of sleepiness/wakefulness and of melatonin levels for each subject (including sub-study 1). The second study phase identifies the optimum dose and timing of melatonin for regulating each individual's 24-hour sleep/waking cycle (including sub-study 2). The third study phase introduces a new independent variable, light (including sub-studies 3 and 4). Sub-study 5 is an optional longitudinal study. Sub-study 1 looks at how keeping a regular sleep schedule affects the body's natural rhythm. Sub-study 2 looks at how individuals metabolize melatonin. Sub-study 3 tests how individuals' endogenous melatonin production responds to bright outdoor light and Sub-study 4 tests a previous finding that artificial bright light exposed daily behind the knee can regulate the body clock. Sub-study 5 is an optional longitudinal study, an extension of the first study stage, for subjects whose rhythms are not clearly free-running.

Conditions

• Insomnia
• Blindness
• Daytime Sleepiness

Interventions

Type	Name	Description
DRUG	Melatonin	Melatonin will be administered under FDA IND #26,318, doses between 0.025 mg and 20 mg.
BEHAVIORAL	Regular Sleep Schedule	Subjects will maintain a regular sleep schedule of their choosing.
BEHAVIORAL	Light	Subjects will be exposed to light.

Timeline

• Start date: 1997-06-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2009-06-01
• Last updated: 2019-11-27
• Results posted: 2019-11-27

Locations

1 site across 1 country: United States