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Melatonin for Circadian Sleep Disorders in the Blind

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Oregon Health and Science University
Sponsor:
Information provided by (Responsible Party):
Alfred Lewy, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00911053
First received: May 7, 2009
Last updated: November 9, 2013
Last verified: November 2013
  Purpose

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 Intervention
Insomnia
Blindness
Daytime Sleepiness
Drug: Melatonin
Behavioral: Regular Sleep Schedule
Behavioral: Light

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Melatonin for Circadian Sleep Disorders in the Blind

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Treatment effects on circadian phase will be assessed during each trial by measuring the timing of endogenous melatonin secretion. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: June 1997
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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: R01 EY018312
Study First Received: May 7, 2009
Last Updated: November 9, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 23, 2014