Melatonin Adolescent Research Study

Study Overview
=================
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).

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

Conditions
-----------------
Sleep Disorders in Children

Intervention / Treatment
-----------------
* Dietary Supplement: Melatonin
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Melatonin, Sleep Disturbance, Adolescents, Daytime Functioning