MARS: Melatonin Adolescent Research Study

Sponsor

Loma Linda University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04588233

Collaborator

(none)

Enrollment

Locations

Arms

18.5

Anticipated Duration (Months)

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Sleep Disorders in Children	Dietary Supplement: Melatonin Other: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Understanding the Impact of Melatonin Use on Adolescent Functioning: A Pilot and Feasibility Trial of the Melatonin Adolescent Research Study (MARS)

Actual Study Start Date :

Sep 15, 2021

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Administration of Melatonin	Dietary Supplement: Melatonin Each subject will receive 3mg of melatonin 1 hour prior to bedtime for 12 consecutive nights
Placebo Comparator: Administration of Placebo	Other: Placebo Each subject will receive a placebo 1 hour prior to bedtime for 12 consecutive nights

Arm

Intervention/Treatment

Experimental: Administration of Melatonin

Dietary Supplement: Melatonin

Each subject will receive 3mg of melatonin 1 hour prior to bedtime for 12 consecutive nights

Placebo Comparator: Administration of Placebo

Other: Placebo

Each subject will receive a placebo 1 hour prior to bedtime for 12 consecutive nights

Outcome Measures

Primary Outcome Measures

Change in Objective Sleep Duration During Melatonin Administration [Change between baseline and two weeks]
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
Change in Objective Sleep Duration During Placebo Administration [Change between baseline and two weeks]
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

Secondary Outcome Measures

Change in Emotion Regulation During Melatonin Administration as Evidenced by the Emotion Regulation Index for Children and Adolescents (ERICA) [Change between baseline and two weeks]
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.
Change in Emotion Regulation During Placebo Administration as Evidenced by the Emotion Regulation Index for Children and Adolescents (ERICA) [Change between baseline and two weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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
Daily consumption of >1 caffeinated beverage
Risk for any organic sleep disorder (e.g., obstructive sleep apnea, restless leg syndrome)