Melatonin for Circadian Sleep Disorders in the Blind
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|ClinicalTrials.gov Identifier: NCT00911053|
Recruitment Status : Unknown
Verified November 2014 by Alfred Lewy, Oregon Health and Science University.
Recruitment status was: Recruiting
First Posted : June 1, 2009
Last Update Posted : November 6, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Insomnia Blindness Daytime Sleepiness||Drug: Melatonin Behavioral: Regular Sleep Schedule Behavioral: Light||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||Melatonin for Circadian Sleep Disorders in the Blind|
|Study Start Date :||June 1997|
|Estimated Primary Completion Date :||March 2015|
|Estimated Study Completion Date :||March 2015|
|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.
- 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 ]
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): NCT00911053
|Contact: Andie Thompsonfirstname.lastname@example.org|
|United States, Oregon|
|Oregon Health and Science University||Recruiting|
|Portland, Oregon, United States, 07239|
|Contact: Andie Thompson, BA 866-424-6060 email@example.com|
|Principal Investigator: Alfred Lewy, MD, PhD|
|Principal Investigator:||Alfred Lewy, MD, PhD||Oregon Health and Science University|