Melatonin for Circadian Sleep Disorders in the Blind

NCT ID: NCT00911053

Last Updated: 2019-11-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-06-30
• Study Completion Date: 2012-06-30

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.

Conditions

Insomnia; Blindness; Daytime Sleepiness

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Baseline

Group Type: NO_INTERVENTION

No interventions assigned to this group

Melatonin

Subjects will be administered melatonin.

Group Type: EXPERIMENTAL

Melatonin

Intervention Type: DRUG

Melatonin will be administered under FDA IND #26,318, doses between 0.025 mg and 20 mg.

Light

Group Type: EXPERIMENTAL

Light

Intervention Type: BEHAVIORAL

Subjects will be exposed to light.

Regular Sleep Schedule

Group Type: EXPERIMENTAL

Regular Sleep Schedule

Intervention Type: BEHAVIORAL

Subjects will maintain a regular sleep schedule of their choosing.

Longitudinal Monitoring

Optional longitudinal study, an extension of the first study stage, for subjects whose rhythms are not clearly free-running.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Melatonin

Melatonin will be administered under FDA IND #26,318, doses between 0.025 mg and 20 mg.

Intervention Type: DRUG

Regular Sleep Schedule

Subjects will maintain a regular sleep schedule of their choosing.

Intervention Type: BEHAVIORAL

Light

Subjects will be exposed to light.

Intervention Type: BEHAVIORAL

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alfred Lewy, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health and Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

R01EY018312

Identifier Type: NIH

Identifier Source: org_study_id

View Link

NCT00686907

Identifier Type: -

Identifier Source: nct_alias