Melatonin for Circadian Sleep Disorders in the Blind

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.

Study Overview

• Status: Terminated
• Conditions: Insomnia; Blindness; Daytime Sleepiness
• Intervention / Treatment: Drug: Melatonin; Behavioral: Light; Behavioral: Regular Sleep Schedule

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 07239
      • Oregon Health and Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Treatment Effects on Circadian Phase Will be Assessed During Each Trial by Measuring the Timing of Endogenous Melatonin Secretion.	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	1 year

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Alfred Lewy, MD, PhD, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start: June 1, 1997
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: May 7, 2009
• First Submitted That Met QC Criteria: May 28, 2009
• First Posted (Estimate): June 1, 2009

Study Record Updates

• Last Update Posted (Actual): November 27, 2019
• Last Update Submitted That Met QC Criteria: November 8, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: sleep; melatonin; blindness; blind individuals
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders; Sleep Wake Disorders; Parasomnias; Blindness; Disorders of Excessive Somnolence; Sleepiness; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: R01EY018312 (U.S. NIH Grant/Contract)