Melatonin Studies of Totally Blind Children

NCT00795236 | Terminated Results

• 2 other identifiers: eIRB 46642R01HD042125-06
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn more about abnormal body rhythms in blind boys and girls that keep them from falling asleep at bed-time or cause them difficulty staying alert during the day. The investigators hope to learn if there are any differences between the body rhythms of girls and boys. The investigators also want to investigate whether age or puberty have an effect on body rhythms.

Conditions

Sleep Disorder; Blindness

Keywords

melatonin

Outcome Measures

Primary Outcomes (3)

• To Test for a Proportional Gender Difference in Circadian Status (Free-running Versus Entrained) in Blind Children and in Adolescents, a Chi-square Test of Significance Will be Used for Each Age Group.

  Approximately 1 year

• To Test for a Proportional Difference in Circadian Status (Free-running Versus Entrained) Between Pre and Post- Pubertal Males in Blind Boys and Young Men, a Chi-square Test of Significance Will be Used for Each Age Group.

  Approximately 1 year

• To Determine the Efficacy of Melatonin Treatment in Entraining Blind Free-running Children and Young Adults, a Binomial Test Will be Used.

  Approximately 1 year

Study Arms (2)

Observational

NO INTERVENTION

Observe to determine free-running versus entrained status.

Melatonin

EXPERIMENTAL

Subjects with free-running rhythms will take melatonin.

Drug: Melatonin

Interventions

Melatonin DRUG

One 0.5 mg tablet of melatonin will be taken by subjects who are free-running and willing to enter the intervention phase of the study. These subjects will take melatonin until entrainment status is confirmed or throughout the duration of the study.

Melatonin

Eligibility Criteria

• Age: 5 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Totally blind
• Between 5-8 yrs or 17-20 yrs of age

You may not qualify if:

• Pregnancy
• Light perception
• Low melatonin production
• Taking melatonin
• Co-morbid medical disorders (such as seizure disorders)

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Sleep Wake Disorders; Blindness

Interventions

Melatonin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Limitations and Caveats

Technical problems with measurement leading to unreliable or uninterpretable data; Consistently could not obtain a complete melatonin profile from participants' saliva samplings and thus could not determine melatonin onset.

Results Point of Contact

• Title: Alfred Lewy
• Organization: Oregon Health & Science University

lewy@ohsu.edu

(503) 494-7746

Study Officials

• Alfred Lewy, MD, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2008
• First Posted: November 21, 2008
• Study Start: November 1, 2009
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: November 27, 2019
• Results First Posted: November 27, 2019

Record last verified: 2019-11

Locations

US (1)