Melatonin for Circadian Sleep Disorders in the Blind
Recruitment status was: Recruiting
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.
|Insomnia Blindness Daytime Sleepiness||Drug: Melatonin Behavioral: Regular Sleep Schedule Behavioral: Light|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
|Official Title:||Melatonin for Circadian Sleep Disorders in the Blind|
- Treatment effects on circadian phase will be assessed during each trial by measuring the timing of endogenous melatonin secretion. [ Time Frame: 1 year ]
- Treatment effects on sleep and alertness will be assessed by daily diaries and daily wrist actigraphic monitoring. Subjective benefits will be assessed with daily ratings of alertness and vigor. [ Time Frame: 1 year ]
|Study Start Date:||June 1997|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
|No Intervention: Baseline|
Subjects will be administered melatonin.
Melatonin will be administered under FDA IND #26,318, doses between 0.025 mg and 20 mg.
Subjects will be exposed to light.
|Experimental: Regular Sleep Schedule||
Behavioral: Regular Sleep Schedule
Subjects will maintain a regular sleep schedule of their choosing.
No Intervention: Longitudinal Monitoring
Optional longitudinal study, an extension of the first study stage, for subjects whose rhythms are not clearly free-running.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00911053
|Contact: Andie Thompsonemail@example.com|
|United States, Oregon|
|Oregon Health and Science University||Recruiting|
|Portland, Oregon, United States, 07239|
|Contact: Andie Thompson, BA 866-424-6060 firstname.lastname@example.org|
|Principal Investigator: Alfred Lewy, MD, PhD|
|Principal Investigator:||Alfred Lewy, MD, PhD||Oregon Health and Science University|