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Melatonin Studies of Totally Blind Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00795236
Recruitment Status : Terminated (Unique provision in the American Recovery and Reinvestment Act prevented approval of second year no-cost-extension in which completion of analyses were planned.)
First Posted : November 21, 2008
Results First Posted : November 27, 2019
Last Update Posted : November 27, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Oregon Health and Science University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Sleep Disorder
Blindness
Intervention Drug: Melatonin
Enrollment 13
Recruitment Details  
Pre-assignment Details The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
Arm/Group Title Melatonin Observational
Hide Arm/Group Description

Subjects with free-running rhythms will take melatonin.

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.

Observe to determine free-running versus entrained status.
Period Title: Overall Study
Started 0 0
Completed 0 [1] 0
Not Completed 0 0
[1]
Unable to consistently obtain saliva DLMO in subjects and thus couldn't measure circadian period
Arm/Group Title Melatonin Observational Total
Hide Arm/Group Description

Subjects with free-running rhythms will take melatonin.

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.

Observe to determine free-running versus entrained status. Total of all reporting groups
Overall Number of Baseline Participants 0 0 0
Hide Baseline Analysis Population Description
The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
Age, Categorical  
Number Analyzed 0 participants 0 participants 0 participants
<=18 years
Between 18 and 65 years
>=65 years
Age, Continuous  
Number Analyzed 0 participants 0 participants 0 participants
Sex: Female, Male  
Number Analyzed 0 participants 0 participants 0 participants
Female
Male
Region of Enrollment  
Unit of measure:  Participants
United States Number Analyzed 0 participants 0 participants 0 participants
1.Primary Outcome
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.
Hide Description [Not Specified]
Time Frame Approximately 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
Arm/Group Title Observational Melatonin
Hide Arm/Group Description:
Observe to determine free-running versus entrained status.

Subjects with free-running rhythms will take melatonin.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
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.
Hide Description [Not Specified]
Time Frame Approximately 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
Arm/Group Title Melatonin Observational
Hide Arm/Group Description:

Subjects with free-running rhythms will take melatonin.

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.

Observe to determine free-running versus entrained status.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title To Determine the Efficacy of Melatonin Treatment in Entraining Blind Free-running Children and Young Adults, a Binomial Test Will be Used.
Hide Description [Not Specified]
Time Frame Approximately 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
Arm/Group Title Melatonin Observational
Hide Arm/Group Description:

Subjects with free-running rhythms will take melatonin.

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.

Observe to determine free-running versus entrained status.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
 
Arm/Group Title Melatonin Observational
Hide Arm/Group Description

Subjects with free-running rhythms will take melatonin.

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.

Observe to determine free-running versus entrained status.
All-Cause Mortality
Melatonin Observational
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Serious Adverse Events
Melatonin Observational
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Melatonin Observational
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Alfred Lewy
Organization: Oregon Health & Science University
Phone: (503) 494-7746
EMail: lewy@ohsu.edu
Layout table for additonal information
Responsible Party: Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00795236    
Other Study ID Numbers: eIRB 4664
2R01HD042125-06 ( U.S. NIH Grant/Contract )
First Submitted: November 19, 2008
First Posted: November 21, 2008
Results First Submitted: April 7, 2014
Results First Posted: November 27, 2019
Last Update Posted: November 27, 2019