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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
Sponsor:
Information provided by (Responsible Party):
Alfred Lewy, Oregon Health and Science University

Brief 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.


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
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Disorders
Drug Information available for: Melatonin
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Baseline
Experimental: Melatonin
Subjects will be administered melatonin.
Drug: Melatonin
Melatonin will be administered under FDA IND #26,318, doses between 0.025 mg and 20 mg.
Experimental: Light Behavioral: Light
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.



Primary Outcome Measures :
  1. Treatment effects on circadian phase will be assessed during each trial by measuring the timing of endogenous melatonin secretion. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • blindness for at least one year, verified by an ophthalmologic exam
  • ability to comply with the requirements of the experimental protocol
  • competency to sign informed consent

Exclusion criteria (as determined by medical history and/or physical examination):

  • abnormal heart, liver or kidney function
  • a current Axis I psychiatric or substance abuse disorder according to the DSM-IV Manual
  • possibly external demands that limit the ability to maintain a regular schedule (e.g., night shift work)
  • sexually active female subjects of child-bearing potential will be asked to avoid pregnancy using accepted methods and will be notified that the effects of melatonin on a fetus are not known (we will ask subjects monthly if they are pregnant or trying to become pregnant)
  • if a subject reports she is pregnant or is trying to become pregnant anytime during her study participation, any study medications (melatonin or placebo) will be immediately withdrawn and the subject will be excluded from the study

Information from the National Library of Medicine

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


Contacts
Contact: Andie Thompson 1-866-424-6060 sleeplab@ohsu.edu

Locations
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 07239
Contact: Andie Thompson, BA    866-424-6060    sleeplab@ohsu.edu   
Principal Investigator: Alfred Lewy, MD, PhD         
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Alfred Lewy, MD, PhD Oregon Health and Science University

Responsible Party: Alfred Lewy, Senior Vice Chair and Professor, Psychiatry, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00911053     History of Changes
Other Study ID Numbers: R01EY018312 ( U.S. NIH Grant/Contract )
First Posted: June 1, 2009    Key Record Dates
Last Update Posted: November 6, 2014
Last Verified: November 2014

Keywords provided by Alfred Lewy, Oregon Health and Science University:
melatonin
sleep
blindness
blind individuals

Additional relevant MeSH terms:
Sleep Wake Disorders
Parasomnias
Blindness
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Vision Disorders
Sensation Disorders
Eye Diseases
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants