NCT00688935

Brief Summary

The primary goal of this study is to identify the presence of desynchronized circadian rhythms in 25 children by measuring melatonin secretion in serial blood or saliva samples, and to rule out any primary sleep disorders.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 3, 2008

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

November 27, 2019

Completed
Last Updated

November 27, 2019

Status Verified

November 1, 2019

Enrollment Period

10.3 years

First QC Date

May 30, 2008

Results QC Date

November 8, 2019

Last Update Submit

November 8, 2019

Conditions

Blindness

Keywords

melatonincircadian rhythmssleepsleep disorders

Outcome Measures

Primary Outcomes (1)

  • Circadian Phase Marker, as Measured by the Melatonin Levels in Salivary, Plasma and/or Urine Serial Sampling.

    every 2-4 weeks throughout the entire study

Secondary Outcomes (1)

  • Polysomnography (Sleep Assessment)

    1 12-hour assessment any time during the study

Study Arms (1)

Melatonin

EXPERIMENTAL

Subjects may opt to enroll in this treatment sub-study involving melatonin treatment (0.1 - 3 mg, daily) for up to 1 year, with a minimum of 6 weeks. Throughout treatment, subjects will continue their saliva, plasma, and/or urine sampling to test for treatment efficacy.

Biological: Melatonin

Interventions

MelatoninBIOLOGICAL

0.1-3 mg, daily, up to 1 year (minimum duration of 6 weeks)

Melatonin

Eligibility Criteria

Age1 Year - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 1-20 years
  • Blindness for the past year (verified by an ophthalmologic exam), but otherwise in general good health.

You may not qualify if:

  • Abnormal heart, lung, kidney, liver disease or a primary sleep disorder,
  • Significant clinical abnormalities (other than blindness),
  • Use of medications with known effects on melatonin metabolism (e.g. beta-adrenergic blocking drugs or tricyclic antidepressants).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sleep and Mood Disorders Lab, Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (3)

  • Palm L, Blennow G, Wetterberg L. Long-term melatonin treatment in blind children and young adults with circadian sleep-wake disturbances. Dev Med Child Neurol. 1997 May;39(5):319-25. doi: 10.1111/j.1469-8749.1997.tb07438.x.

    PMID: 9236698BACKGROUND

  • Sack RL, Lewy AJ, Blood ML, Keith LD, Nakagawa H. Circadian rhythm abnormalities in totally blind people: incidence and clinical significance. J Clin Endocrinol Metab. 1992 Jul;75(1):127-34. doi: 10.1210/jcem.75.1.1619000.

    PMID: 1619000BACKGROUND

  • Tzischinsky O, Skene D, Epstein R, Lavie P. Circadian rhythms in 6-sulphatoxymelatonin and nocturnal sleep in blind children. Chronobiol Int. 1991;8(3):168-75. doi: 10.3109/07420529109063923.

    PMID: 1794154BACKGROUND

MeSH Terms

Conditions

BlindnessSleep Wake Disorders

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Limitations and Caveats

Analyses were not completed because, a unique provision in the American Recovery and Reinvestment Act (ARRA) of 2009 funding source unexpectedly prevented approval of a second year no-cost-extension in which completion of analyses were planned.

Results Point of Contact

Title
OHSU Integrity Department
Organization
Oregon Health and Science University
irb@ohsu.edu
1-877-733-8313

Study Officials

  • Alfred J Lewy, MD, PhD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2008

First Posted

June 3, 2008

Study Start

January 1, 2005

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

November 27, 2019

Results First Posted

November 27, 2019

Record last verified: 2019-11

Locations

US(1)