Melatonin Studies of Totally Blind Children

• Sponsor: Oregon Health and Science University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00795236
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 13
• Location: 1
• Arms: 2
• Duration (Months): 67
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Disorder; Blindness	Drug: Melatonin	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Melatonin Studies in Young Blind Children and Adolescents
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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]

2. 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]

3. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 20 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oregon Health and Science University	Portland	Oregon	United States	97239

Sponsors and Collaborators

• Oregon Health and Science University
• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Oregon Health and Science University
• ClinicalTrials.gov Identifier: NCT00795236
• Other Study ID Numbers: eIRB 4664; 2R01HD042125-06
• First Posted: Nov 21, 2008
• Last Update Posted: Nov 27, 2019
• Last Verified: Nov 1, 2019

• Keywords provided by Oregon Health and Science University: melatonin
• Additional relevant MeSH terms: Sleep Wake Disorders; Blindness; Melatonin

Study Results

Participant Flow

Pre-assignment Detail	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
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	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Melatonin	Observational	Total
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 Participants	0	0	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Age () []
Sex: Female, Male () []
Female
Male
Region of Enrollment (participants) []

Outcome Measures

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.
Time Frame	Approximately 1 year

Outcome Measure Data

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
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.
Measure Participants	0	0

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.
Time Frame	Approximately 1 year

Outcome Measure Data

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
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.
Measure Participants	0	0

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.
Time Frame	Approximately 1 year

Outcome Measure Data

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
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.
Measure Participants	0	0

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Melatonin		Observational
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Melatonin		Observational
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.