Melatonin for Circadian Sleep Disorders in the Blind

NCT00911053 | Terminated Results

• 1 other identifier: R01EY018312
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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

Keywords

melatonin; sleep; blindness; blind individuals

Outcome Measures

Primary Outcomes (1)

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

  1 year

Secondary Outcomes (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

Study Arms (5)

Baseline

NO INTERVENTION

Melatonin

EXPERIMENTAL

Subjects will be administered melatonin.

Drug: Melatonin

Light

EXPERIMENTAL

Behavioral: Light

Regular Sleep Schedule

EXPERIMENTAL

Behavioral: Regular Sleep Schedule

Longitudinal Monitoring

NO INTERVENTION

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

Interventions

Melatonin DRUG

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

Melatonin

Regular Sleep Schedule BEHAVIORAL

Subjects will maintain a regular sleep schedule of their choosing.

Regular Sleep Schedule

Light BEHAVIORAL

Subjects will be exposed to light.

Light

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 07239, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Blindness; Disorders of Excessive Somnolence

Interventions

Melatonin; Light

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Optical Phenomena; Radiation; Radiation, Nonionizing

Limitations and 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.

Results Point of Contact

• Title: OHSU IRB
• Organization: Oregon Health and Science University

irb@ohsu.edu

5034948849

Study Officials

• Alfred Lewy, MD, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2009
• First Posted: June 1, 2009
• Study Start: June 1, 1997
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: November 27, 2019
• Results First Posted: November 27, 2019

Record last verified: 2019-11

Locations

US (1)