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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

About this trial

This is an interventional treatment trial for Insomnia focused on measuring melatonin, sleep, blindness, blind individuals

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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pregnant anytime during her study participation, any study medications (melatonin or placebo) will be immediately withdrawn and the subject will be excluded from the study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

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

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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