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Melatonin Studies of Totally Blind Children

Primary Purpose

Sleep Disorder, Blindness

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Melatonin
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disorder focused on measuring melatonin

Eligibility Criteria

5 Years - 20 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Oregon Health and Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Observational

Melatonin

Arm Description

Observe to determine free-running versus entrained status.

Subjects with free-running rhythms will take melatonin.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 19, 2008
Last Updated
November 8, 2019
Sponsor
Oregon Health and Science University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00795236
Brief Title
Melatonin Studies of Totally Blind Children
Official Title
Melatonin Studies in Young Blind Children and Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
Unique provision in the American Recovery and Reinvestment Act prevented approval of second year no-cost-extension in which completion of analyses were planned.
Study Start Date
November 2009 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Health and Science University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorder, Blindness
Keywords
melatonin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Observational
Arm Type
No Intervention
Arm Description
Observe to determine free-running versus entrained status.
Arm Title
Melatonin
Arm Type
Experimental
Arm Description
Subjects with free-running rhythms will take melatonin.
Intervention Type
Drug
Intervention Name(s)
Melatonin
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfred Lewy, MD, PhD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

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Melatonin Studies of Totally Blind Children

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