Sleep Disorders in ChildrenMARSNCT04588233
Melatonin Adolescent Research Study
A study testing Melatonin in people with Sleep Disorders in Children, run by Loma Linda University at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Sleep Disorders in Children
- What is being tested?
- Melatonin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Sep 2021to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Loma Linda University
Loma Linda, California, 92350
Tori Van Dyk, PhD, 909-558-7412, tvandyk@llu.edu
- Recruiting
Loma Linda U
Loma Linda, California, 92354
georgia Hodgkin, PhD
About this study
Official title: Understanding the Impact of Melatonin Use on Adolescent Functioning: A Pilot and Feasibility Trial of the Melatonin Adolescent Research Study (MARS)
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).
- Conditions
- Sleep Disorders in Children
- Being tested
- Melatonin, Placebo
- Keywords
- Melatonin, Sleep Disturbance, Adolescents, Daytime Functioning
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDietary supplement
Each subject will receive 3mg of melatonin 1 hour prior to bedtime for 12 consecutive nights
PlaceboOther
Each subject will receive a placebo 1 hour prior to bedtime for 12 consecutive nights
| Study group | Role | What they receive |
|---|---|---|
| Administration of Melatonin | Experimental | Not described Receives: Dietary Supplement: Melatonin |
| Administration of Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Change between baseline and two weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: Change between baseline and two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start15 Sep 2021
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disorders in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tori Van Dyk, PhD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588233
- Sponsor's protocol ID
- 5200334
- Acronym
- MARS
- Status last verified
- Jul 2026
- First submitted
- 7 Oct 2020
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Impact of Melatonin Use on Adolescent Functioning: A Pilot and Feasibility Trial of the Melatonin Adolescent Research Study (MARS)
- ClinicalTrials.gov ID
- NCT04588233
- Acronym / sponsor ID
- MARS / 5200334
- Conditions
- Sleep Disorders in Children
- Keywords
- Melatonin, Sleep Disturbance, Adolescents, Daytime Functioning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Administration of Melatonin | Experimental | Dietary Supplement: Melatonin |
| Administration of Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MelatoninEach subject will receive 3mg of melatonin 1 hour prior to bedtime for 12 consecutive nights | Dietary supplement | Administration of Melatonin |
| PlaceboEach subject will receive a placebo 1 hour prior to bedtime for 12 consecutive nights | Other | Administration of Placebo |
Primary outcome
Change in Objective Sleep Duration During Melatonin Administration
Time frame: 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
Time frame: 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
2 secondary outcomes
Change in Emotion Regulation During Melatonin Administration as Evidenced by the Emotion Regulation Index for Children and Adolescents (ERICA)
Time frame: 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)
Time frame: Change between baseline and two weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tori Van Dyk, PhD principal investigator
Loma Linda University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin in people with Sleep Disorders in Children, run by Loma Linda University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brooke Iwamoto (909-558-7412, biwamoto@llu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Objective Sleep Duration During Melatonin Administration (time frame: Change between baseline and two weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.