Melatonin for Circadian Sleep Disorders in the Blind

Sponsor
Oregon Health and Science University (Other)
Overall Status
Terminated
CT.gov ID
NCT00911053
Collaborator
(none)
59
1
5
180
0.3

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

Study Type:
Interventional
Actual Enrollment :
59 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 :
Jun 1, 1997
Actual Primary Completion Date :
Jun 1, 2012
Actual Study Completion Date :
Jun 1, 2012

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

  1. Treatment Effects on Circadian Phase Will be Assessed During Each Trial by Measuring the Timing of Endogenous Melatonin Secretion. [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. [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

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.
Responsible Party:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00911053
Other Study ID Numbers:
  • R01EY018312
  • NCT00686907
First Posted:
Jun 1, 2009
Last Update Posted:
Nov 27, 2019
Last Verified:
Nov 1, 2019
Keywords provided by Oregon Health and Science University
Additional relevant MeSH terms:

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

1. Primary Outcome
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
2. Secondary Outcome
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

Analyses were not completed because a unique provision in the American Recovery and Reinvestment Act (ARRA) of 2009 funding source unexpectedly prevented approval of a second year no-cost-extension in which completion of analyses were planned.

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
Email irb@ohsu.edu
Responsible Party:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00911053
Other Study ID Numbers:
  • R01EY018312
  • NCT00686907
First Posted:
Jun 1, 2009
Last Update Posted:
Nov 27, 2019
Last Verified:
Nov 1, 2019