Melatonin for Circadian Sleep Disorders in the Blind
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
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. |
Outcome Measures
Primary Outcome Measures
- Treatment Effects on Circadian Phase Will be Assessed During Each Trial by Measuring the Timing of Endogenous Melatonin Secretion. [1 year]
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. [1 year]
Eligibility Criteria
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):
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abnormal heart, liver or kidney function
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a current Axis I psychiatric or substance abuse disorder according to the DSM-IV Manual
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possibly external demands that limit the ability to maintain a regular schedule (e.g., night shift work)
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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
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Oregon Health and Science University | Portland | Oregon | United States | 07239 |
Sponsors and Collaborators
- Oregon Health and Science University
Investigators
- Principal Investigator: Alfred Lewy, MD, PhD, Oregon Health and Science University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R01EY018312
- NCT00686907
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available. |
Arm/Group Title | Baseline | Melatonin | Light | Regular Sleep Schedule | Longitudinal Monitoring |
---|---|---|---|---|---|
Arm/Group Description | Subjects will be administered melatonin. Melatonin: Melatonin will be administered under FDA IND #26,318, doses between 0.025 mg and 20 mg. | Light: Subjects will be exposed to light. | Regular Sleep Schedule: Subjects will maintain a regular sleep schedule of their choosing. | Optional longitudinal study, an extension of the first study stage, for subjects whose rhythms are not clearly free-running. | |
Period Title: Overall Study | |||||
STARTED | 0 | 0 | 0 | 0 | 0 |
COMPLETED | 0 | 0 | 0 | 0 | 0 |
NOT COMPLETED | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Baseline | Melatonin | Light | Regular Sleep Schedule | Longitudinal Monitoring | Total |
---|---|---|---|---|---|---|
Arm/Group Description | Subjects will be administered melatonin. Melatonin: Melatonin will be administered under FDA IND #26,318, doses between 0.025 mg and 20 mg. | Light: Subjects will be exposed to light. | Regular Sleep Schedule: Subjects will maintain a regular sleep schedule of their choosing. | Optional longitudinal study, an extension of the first study stage, for subjects whose rhythms are not clearly free-running. | Total of all reporting groups | |
Overall Participants | 0 | 0 | 0 | 0 | 0 | 0 |
Age () [] | ||||||
<=18 years | ||||||
Between 18 and 65 years | ||||||
>=65 years | ||||||
Age () [] | ||||||
Sex: Female, Male () [] | ||||||
Female | ||||||
Male | ||||||
Race and Ethnicity Not Collected () [] |
Outcome Measures
Title | Treatment Effects on Circadian Phase Will be Assessed During Each Trial by Measuring the Timing of Endogenous Melatonin Secretion. |
---|---|
Description | |
Time Frame | 1 year |
Outcome Measure Data
Analysis Population Description |
---|
The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available. |
Arm/Group Title | Baseline | Melatonin | Light | Regular Sleep Schedule | Longitudinal Monitoring |
---|---|---|---|---|---|
Arm/Group Description | Subjects will be administered melatonin. Melatonin: Melatonin will be administered under FDA IND #26,318, doses between 0.025 mg and 20 mg. | Light: Subjects will be exposed to light. | Regular Sleep Schedule: Subjects will maintain a regular sleep schedule of their choosing. | Optional longitudinal study, an extension of the first study stage, for subjects whose rhythms are not clearly free-running. | |
Measure Participants | 0 | 0 | 0 | 0 | 0 |
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. |
---|---|
Description | |
Time Frame | 1 year |
Outcome Measure Data
Analysis Population Description |
---|
The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available. |
Arm/Group Title | Baseline | Melatonin | Light | Regular Sleep Schedule | Longitudinal Monitoring |
---|---|---|---|---|---|
Arm/Group Description | Subjects will be administered melatonin. Melatonin: Melatonin will be administered under FDA IND #26,318, doses between 0.025 mg and 20 mg. | Light: Subjects will be exposed to light. | Regular Sleep Schedule: Subjects will maintain a regular sleep schedule of their choosing. | Optional longitudinal study, an extension of the first study stage, for subjects whose rhythms are not clearly free-running. | |
Measure Participants | 0 | 0 | 0 | 0 | 0 |
Adverse Events
Time Frame | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available. | |||||||||
Arm/Group Title | Baseline | Melatonin | Light | Regular Sleep Schedule | Longitudinal Monitoring | |||||
Arm/Group Description | Subjects will be administered melatonin. Melatonin: Melatonin will be administered under FDA IND #26,318, doses between 0.025 mg and 20 mg. | Light: Subjects will be exposed to light. | Regular Sleep Schedule: Subjects will maintain a regular sleep schedule of their choosing. | Optional longitudinal study, an extension of the first study stage, for subjects whose rhythms are not clearly free-running. | ||||||
All Cause Mortality |
||||||||||
Baseline | Melatonin | Light | Regular Sleep Schedule | Longitudinal Monitoring | ||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | |||||
Serious Adverse Events |
||||||||||
Baseline | Melatonin | Light | Regular Sleep Schedule | Longitudinal Monitoring | ||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
Baseline | Melatonin | Light | Regular Sleep Schedule | Longitudinal Monitoring | ||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | OHSU IRB |
---|---|
Organization | Oregon Health and Science University |
Phone | 5034948849 |
irb@ohsu.edu |
- R01EY018312
- NCT00686907