Melatonin for Circadian Sleep Disorders in the Blind
Primary Purpose
Insomnia, Blindness, Daytime Sleepiness
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Melatonin
Regular Sleep Schedule
Light
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring melatonin, sleep, blindness, blind individuals
Eligibility 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pregnant anytime during her study participation, any study medications (melatonin or placebo) will be immediately withdrawn and the subject will be excluded from the study
Sites / Locations
- Oregon Health and Science University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
No Intervention
Experimental
Experimental
Experimental
No Intervention
Arm Label
Baseline
Melatonin
Light
Regular Sleep Schedule
Longitudinal Monitoring
Arm Description
Subjects will be administered melatonin.
Optional longitudinal study, an extension of the first study stage, for subjects whose rhythms are not clearly free-running.
Outcomes
Primary Outcome Measures
Treatment Effects on Circadian Phase Will be Assessed During Each Trial by Measuring the Timing of Endogenous Melatonin Secretion.
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.
Full Information
NCT ID
NCT00911053
First Posted
May 7, 2009
Last Updated
November 8, 2019
Sponsor
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT00911053
Brief Title
Melatonin for Circadian Sleep Disorders in the Blind
Official Title
Melatonin for Circadian Sleep Disorders in the Blind
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
Unique provision in the American Recovery and Reinvestment Act prevented approval of second year no-cost-extension in which completion of analyses were planned.
Study Start Date
June 1997 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Health and Science University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Blindness, Daytime Sleepiness
Keywords
melatonin, sleep, blindness, blind individuals
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Baseline
Arm Type
No Intervention
Arm Title
Melatonin
Arm Type
Experimental
Arm Description
Subjects will be administered melatonin.
Arm Title
Light
Arm Type
Experimental
Arm Title
Regular Sleep Schedule
Arm Type
Experimental
Arm Title
Longitudinal Monitoring
Arm Type
No Intervention
Arm Description
Optional longitudinal study, an extension of the first study stage, for subjects whose rhythms are not clearly free-running.
Intervention Type
Drug
Intervention Name(s)
Melatonin
Intervention Description
Melatonin will be administered under FDA IND #26,318, doses between 0.025 mg and 20 mg.
Intervention Type
Behavioral
Intervention Name(s)
Regular Sleep Schedule
Intervention Description
Subjects will maintain a regular sleep schedule of their choosing.
Intervention Type
Behavioral
Intervention Name(s)
Light
Intervention Description
Subjects will be exposed to light.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfred Lewy, MD, PhD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
07239
Country
United States
12. IPD Sharing Statement
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Melatonin for Circadian Sleep Disorders in the Blind
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