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Melatonin for Circadian Sleep Disorders in the Blind

NCT00911053 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2019-11-27

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Alfred Lewy, MD, PhD · Oregon Health and Science University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-06-30
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00911053 on ClinicalTrials.gov