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NCT00825591 · ClinicalTrials.gov registry record · Early Phase 1
Biological Clock Dysfunction in Optic Nerve Hypoplasia
A Early Phase 1 study, sponsored by Yale University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 100
- Enrollment target
NCT00825591 is a Early Phase 1 study that has completed, run by Yale University. The registered enrollment target is 100 participants.
The verdict
NCT00825591, a Early Phase 1 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 100 participants
- Enrollment target
Study Summary
Background: Optic Nerve Hypoplasia (ONH) is a leading cause of blindness in children. For unclear reasons, the incidence of ONH is increasing, with ONH affecting about 1 in 10,000 live-born infants. In addition to visual deficits, ONH is associated with varying degrees of hypopituitarism, developmental delay, brain malformations and obesity. Although genetic mutations have been rarely observed to result in ONH, the causes of ONH are largely not known. In limited anatomical observations, the suprachiasmatic nuclei (SCN) located in the anterior hypothalamus, which generate circadian rhythms, have been observed to be abnormal in children with ONH. Thus, children with ONH may have biological clock dysfunction. In collaborative studies with Dr. Mark Borchert of Childrens Hospital Los Angeles (CHLA), we have recently discovered that one-half of children with ONH have grossly abnormal sleep-wake patterns, as assessed by actigraphy. Although not known for children with ONH, abnormal sleep-wake patterns have been observed to be associated with neurocognitive impairment and obesity. We also observe that nocturnal melatonin administration can improve abnormal sleep-wake cycles in these children, raising the possibility that it will be possible to treat abnormal rhythmicity in children with ONH.
Interventions
- DIETARY_SUPPLEMENT Melatonin
- DIETARY_SUPPLEMENT Placebo Comparator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2008-10 |
| Est. Completion | 2011-09 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00825591
The ClinicalTrials.gov registry entry for NCT00825591 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Melatonin is the first listed.
NCT00825591 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00825591 about?
NCT00825591 is a clinical study titled "Biological Clock Dysfunction in Optic Nerve Hypoplasia". Background: Optic Nerve Hypoplasia (ONH) is a leading cause of blindness in children. For unclear reasons, the incidence of ONH is increasing, with ONH affecting about 1 in 10,000 live-born infants. In addition to visual deficits, ONH is associated with varying degrees of hypopituitarism, developmen...
What is the current status of trial NCT00825591?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 100 participants. The study started on 2008-10. Estimated completion is 2011-09.
What interventions are being tested in trial NCT00825591?
The interventions under investigation include: Melatonin (DIETARY_SUPPLEMENT), Placebo Comparator (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00825591?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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