Melatonin Adolescent Research Study
ConditionSleep Disorders in Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-17
SponsorLoma Linda University
About this trial
The present study will use a within-person, randomized cross-over experimental design to test the effects of exogenous melatonin supplementation on the sleep and daytime functioning of typically developing adolescents with short or disrupted sleep of behavioral origins (i.e., difficulty falling asleep, staying asleep, or premature waking resulting in short or disrupted sleep not attributed to an organic sleep condition).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Self-identified sleep difficulties (e.g., difficulty falling asleep, staying asleep, or premature waking resulting in short or disrupted sleep).
Ages 13 to 17 years old
Able to understand, read, and write in English
Melatonin naive
Disqualifiers
Obesity
Use of psychiatric medication
Drug(s), or supplements known to affect sleep
History of head injury or concussion with loss of consciousness >1 minute
Trial design
Design model
Crossover
Treatments tested in this trial
Melatonin
Dietary supplementEach subject will receive 3mg of melatonin 1 hour prior to bedtime for 12 consecutive nights
Placebo
Other interventionEach subject will receive a placebo 1 hour prior to bedtime for 12 consecutive nights
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Administration of MelatoninExperimental treatment 1 intervention
Group B: Administration of PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Objective Sleep Duration During Melatonin Administration
Objective sleep will be measured via wrist-worn actigraphy worn nightly for 2 "run-in" nights followed by 12 consecutive nights after receiving melatonin (14 nights/2 weeks total). Changes in objective sleep duration would be demonstrated by either an increase or decrease in number of hours asleep compared to baseline
Time frame
Change between baseline and two weeks2
Change in Objective Sleep Duration During Placebo Administration
Objective sleep will be measured via wrist-worn actigraphy worn nightly for 2 "run-in" nights followed by 12 consecutive nights after receiving placebo (14 nights/2 weeks total). No change in objective sleep duration would be demonstrated compared to baseline
Time frame
Change between baseline and two weeksSecondary outcomes
1
Change in Emotion Regulation During Melatonin Administration as Evidenced by the Emotion Regulation Index for Children and Adolescents (ERICA)
The Emotion Regulation Index for Children and Adolescents (ERICA) is a 16-item adolescent-report measure with scores ranging from 16 to 80 (higher scores indicative of better emotion regulation). This measure will be administered during baseline and after 14 days (2 weeks) including a 2 day "run-in" followed by 12 days of melatonin administration. It is expected that emotion regulation will improve after melatonin administration compared to baseline. Normal emotion regulation varies by individual.
Time frame
Change between baseline and two weeks2
Change in Emotion Regulation During Placebo Administration as Evidenced by the Emotion Regulation Index for Children and Adolescents (ERICA)
The Emotion Regulation Index for Children and Adolescents (ERICA) is a 16-item adolescent-report measure with scores ranging from 16 to 80 (higher scores indicative of better emotion regulation). This measure will be administered during baseline and after 14 days (2 weeks) including a 2 day "run-in" followed by 12 days of placebo administration. It is expected that emotion regulation will remain the same after placebo administration compared to baseline. Normal emotion regulation varies by individual.
Time frame
Change between baseline and two weeksSponsors and contacts
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Source ClinicalTrials.gov