Melatonin Adolescent Research Study (MARS)
Primary Purpose
Sleep Disorders in Children
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Melatonin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Disorders in Children focused on measuring Melatonin, Sleep Disturbance, Adolescents, Daytime Functioning
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)
Sites / Locations
- Loma Linda University
- Loma Linda URecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Administration of Melatonin
Administration of Placebo
Arm Description
Outcomes
Primary Outcome Measures
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 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
Secondary Outcome Measures
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 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.
Full Information
NCT ID
NCT04588233
First Posted
October 7, 2020
Last Updated
September 25, 2023
Sponsor
Loma Linda University
1. Study Identification
Unique Protocol Identification Number
NCT04588233
Brief Title
Melatonin Adolescent Research Study
Acronym
MARS
Official Title
Understanding the Impact of Melatonin Use on Adolescent Functioning: A Pilot and Feasibility Trial of the Melatonin Adolescent Research Study (MARS)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorders in Children
Keywords
Melatonin, Sleep Disturbance, Adolescents, Daytime Functioning
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Administration of Melatonin
Arm Type
Experimental
Arm Title
Administration of Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Melatonin
Intervention Description
Each subject will receive 3mg of melatonin 1 hour prior to bedtime for 12 consecutive nights
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Each subject will receive a placebo 1 hour prior to bedtime for 12 consecutive nights
Primary Outcome Measure Information:
Title
Change in Objective Sleep Duration During Melatonin Administration
Description
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 weeks
Title
Change in Objective Sleep Duration During Placebo Administration
Description
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 weeks
Secondary Outcome Measure Information:
Title
Change in Emotion Regulation During Melatonin Administration as Evidenced by the Emotion Regulation Index for Children and Adolescents (ERICA)
Description
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 weeks
Title
Change in Emotion Regulation During Placebo Administration as Evidenced by the Emotion Regulation Index for Children and Adolescents (ERICA)
Description
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 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brooke Iwamoto
Phone
909-558-7412
Email
biwamoto@llu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tori Van Dyk, PhD
Organizational Affiliation
Loma Linda University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tori Van Dyk, PhD
Phone
909-558-7412
Email
tvandyk@llu.edu
Facility Name
Loma Linda U
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
georgia Hodgkin, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Melatonin Adolescent Research Study
We'll reach out to this number within 24 hrs