Melatonin Studies of Totally Blind Children

November 8, 2019 updated by: Oregon Health and Science University

Melatonin Studies in Young Blind Children and Adolescents

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Subjects will be asked to collect saliva samples in their home hourly throughout the daytime, approximately every 2 weeks. Subjects may be monitored for up to a year, after which they will be discontinued from the study. If subjects are found to be naturally entrained to the 24-hour day, they will be monitored longitudinally for changes. Subjects will be discontinued after their monitoring period is over or after an entrained status has been confirmed. While no specific time commitment is required, we hope most subjects will participant for 4 months - 2 years.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Observational
Observe to determine free-running versus entrained status.
Experimental: Melatonin
Subjects with free-running rhythms will take melatonin.
Drug: Melatonin
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: Approximately 1 year
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.
Time Frame: Approximately 1 year
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.
Time Frame: Approximately 1 year
Approximately 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Alfred Lewy, MD, PhD, Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

November 19, 2008

First Submitted That Met QC Criteria

November 19, 2008

First Posted (Estimate)

November 21, 2008

Study Record Updates

Last Update Posted (Actual)

November 27, 2019

Last Update Submitted That Met QC Criteria

November 8, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • eIRB 4664
  • 2R01HD042125-06 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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