Melatonin Adolescent Research Study

Sleep Disorders in Children Clinical Trial

— MARS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04588233
• Other study ID #: 5200334
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Loma Linda University
• Contact: Brooke Iwamoto
• Phone: 909-558-7412
• Email: biwamoto[@]llu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Sleep Disorders in Children
• Sleep Wake Disorders

Intervention

Dietary Supplement:
• Melatonin
Each subject will receive 3mg of melatonin 1 hour prior to bedtime for 12 consecutive nights

Other:
• Placebo
Each subject will receive a placebo 1 hour prior to bedtime for 12 consecutive nights

Locations

Country	Name	City	State
United States	Loma Linda U	Loma Linda	California
United States	Loma Linda University	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change between baseline and two weeks
Primary	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	Change between baseline and two weeks
Secondary	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.	Change between baseline and two weeks
Secondary	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.	Change between baseline and two weeks