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Biological Clock Dysfunction in Optic Nerve Hypoplasia

Phase < 1
Waitlist Available
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

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.

Eligible Conditions
  • Insomnia
  • Optic Nerve Hypoplasia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: 1Active Control1 Intervention
Individuals with abnormal rhythmicity will be treated with melatonin to assess if sleep patterns are improved.
Group II: 2Placebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Children's Hospital Los AngelesOTHER
249 Previous Clinical Trials
5,074,574 Total Patients Enrolled
1 Trials studying Optic Nerve Hypoplasia
20 Patients Enrolled for Optic Nerve Hypoplasia
Yale UniversityLead Sponsor
1,930 Previous Clinical Trials
3,033,374 Total Patients Enrolled
Casandra FinkStudy DirectorChildren's Hospital Los Angeles
~6 spots leftby Dec 2025