Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
NCT ID:
NCT01700959
Eligibility Criteria:
Inclusion Criteria:
* A St. Jude Life participant who was previously treated at St. Jude Children's Research Hospital
* 10 or more years from diagnosis
* 18 years of age or older
* Able to speak and understand the English language
* Participant has a full scale intelligence quotient (FSIQ) score \>79.
* Cohort 1 participant:
* Has neurocognitive impairment defined as performance on at least one measure of attention, memory, and/or executive functioning ≤10th percentile.
* Is absent of delayed sleep onset latency defined as an inability to fall asleep within 30 minutes \< once a week during the past month.
* Cohort 2 participant:
* Has neurocognitive impairment defined as performance on at least one measure of attention, memory, and/or executive functioning ≤10th percentile.
* Has delayed sleep onset latency defined as self-report of an inability to fall asleep within 30 minutes ≥ once a week during the past month.
* Cohort 3 participant:
* Is absent of neurocognitive impairment defined as performance \>10th percentile on all six measures of attention, memory, and executive functioning.
* Has delayed sleep onset latency defined as self-report of an inability to fall asleep within 30 minutes ≥ once a week during the past month.
* Female participant of childbearing age must not be pregnant or lactating
* Female research participant of childbearing age and male research participant of child fathering potential agrees to use safe contraceptive methods
Exclusion Criteria:
* Known allergy to melatonin or any ingredients of the study product or placebo
* Participant currently is taking melatonin
* Known sleep apnea or medically treated sleep disorder (e.g. restless leg syndrome)
* Known diabetes mellitus - insulin treated
* Participant has uncontrolled seizure disorder in past 12 months
* Reported current illicit drug or alcohol abuse or dependence
* Reported current major psychiatric illness (i.e. schizophrenia, bipolar disorder)
* Current treatment with: (1) benzodiazepines or other central nervous system depressants, (2) fluvoxamine, (3) anticoagulants (e.g. coumadin), (4) immunosuppressant or corticosteroids, OR (5) nifedipine (Procardia XL(R))
* Employed in a position that requires night work (i.e. 10pm to 6am)
* Females who are pregnant or lactating/nursing
* History of neurologic event (i.e. traumatic brain injury) unrelated to cancer or its treatment
* Sensory impairment (vision, hearing) that prohibits completion of neurocognitive examination
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01700959
Study Brief:
Protocol Section:
NCT01700959