Melatonin for Circadian Sleep Disorders in the Blind

Insomnia Clinical Trial

Official title:

Melatonin for Circadian Sleep Disorders in the Blind

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00911053
• Other study ID #: R01EY018312
• Status: Terminated
• Phase: N/A
• Start date: June 1997
• Est. completion date: June 2012

Study information

• Verified date: November 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 59
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Blindness
• Daytime Sleepiness
• Insomnia
• Parasomnias
• Sleep Wake Disorders
• Sleepiness

Intervention

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

Behavioral:
• Regular Sleep Schedule
Subjects will maintain a regular sleep schedule of their choosing.
• Light
Subjects will be exposed to light.

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Effects on Circadian Phase Will be Assessed During Each Trial by Measuring the Timing of Endogenous Melatonin Secretion.		1 year
Secondary	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