Other

Melatonin 3 mg for Sleep Disorder

Institute of Health System Science, New York, NY
Melatonin 3 mg +2 morePhase 1Waitlist AvailableLed by Karina Davidson, PhD, MAScResearch Sponsored by Northwell Health

Study Summary

This trial is testing whether N-of-1 methods can be used to study the effects of melatonin on sleep quality. Participants will be given a Fitbit and 3 bottles of pills, one with melatonin, one with a lower dose of melatonin, and one with a placebo. They will take the pills for 2 weeks, then not take them for 2 weeks, and repeat this 6 times. At the end, they will answer some surveys about the experience.

Eligible Conditions
  • Sleep Disorder

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You are able to take a harmless substitute medication called a placebo, as well as melatonin.
Select...
You have trouble sleeping and have reported it using the Insomnia Symptom Questionnaire (ISQ).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~ema pain will be assessed 3 times daily via text message during the baseline assessment period (2 weeks) and during each of the 6 intervention periods (2 weeks each, 12 weeks total).
This trial's timeline: 3 weeks for screening, Varies for treatment, and ema pain will be assessed 3 times daily via text message during the baseline assessment period (2 weeks) and during each of the 6 intervention periods (2 weeks each, 12 weeks total). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean System Usability Score (SUS)
Participant Satisfaction with Personalized Trial Components
Secondary outcome measures
Mean Fitbit device adherence rate.
Mean Within-Subject Difference in Self-Reported Sleep Quality.
Mean participant adherence to nightly Melatonin 0.5 mg supplement.
+5 more
Other outcome measures
Mean Within-Subject Difference in Self-Reported Sleep Disturbance.
Mean participant ecological momentary assessment (EMA) adherence rate.
Mean participant survey adherence rate.
+6 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Melatonin 3 mgExperimental Treatment1 Intervention
Individuals will receive a kit with medication adherence devices containing melatonin 3 mg in one of three smart electronic pill bottles labeled "A," "B," and "C." Participants will not be aware which of the pill bottles contains the 3mg of melatonin. Participants will be randomized to take pills in 6 alternating intervention periods 2 weeks in length. During periods where participants were randomized to receive melatonin 3 mg, they will receive a nightly text notification 1 hour before bed instructing them to take a pill from the corresponding smart pill bottle. The melatonin 3 mg intervention will be administered in 2 intervention periods each 2 weeks in length (4 weeks total).
Group II: Melatonin 0.5 mgActive Control1 Intervention
Individuals will receive a kit with medication adherence devices containing melatonin 0.5 mg in one of three smart electronic pill bottles labeled "A," "B," and "C." Participants will not be aware which of the pill bottles contains the 0.5 mg of melatonin. Participants will be randomized to take pills in 6 alternating intervention periods 2 weeks in length. During periods where participants were randomized to receive melatonin 0.5 mg, they will receive a nightly text notification 1 hour before bed instructing them to take a pill from the corresponding smart pill bottle. The melatonin 0.5 mg intervention will be administered in 2 intervention periods each 2 weeks in length (4 weeks total).
Group III: Placebo PillPlacebo Group1 Intervention
Individuals will receive a kit with medication adherence devices containing the placebo pills in one of three smart electronic pill bottles labeled "A," "B," and "C." Participants will not be aware which of the pill bottles contains the placebo. Participants will be randomized to take pills in 6 alternating intervention periods 2 weeks in length. During periods where participants were randomized to receive the placebo, they will receive a nightly text notification 1 hour before bed instructing them to take a pill from the corresponding smart pill bottle. The placebo will be administered in 2 intervention periods each 2 weeks in length (4 weeks total).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melatonin 3 mg
2018
Completed Phase 4
~390

Find a site

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Northwell HealthLead Sponsor
438 Previous Clinical Trials
466,856 Total Patients Enrolled
National Library of Medicine (NLM)NIH
38 Previous Clinical Trials
107,406 Total Patients Enrolled
Columbia UniversityOTHER
1,372 Previous Clinical Trials
1,782,376 Total Patients Enrolled
Karina Davidson, PhD, MAScPrincipal Investigator
Northwell Health
6 Previous Clinical Trials
576 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being recruited for this research?

"Affirmative. Based on the data presented by clinicaltrials.gov, this medical research project was initially launched on May 11th 2022 and is actively seeking 60 volunteers from 1 clinic site."

Answered by AI

What potential negative impacts could Melatonin 3 mg have on human health?

"Our team at Power determined that Melatonin 3 mg is relatively low risk, and so assigned it a score of 1. This assessment was based on the fact that this medication has only undertaken Phase 1 clinical trials; limited data exists concerning its safety and efficacy."

Answered by AI

Are there any opportunities for involvement in this medical trial at present?

"Clinicaltrials.gov details that participants are being sought for this medical study; its first posting was on May 11th 2022 and it's been updated as recently as July 7th 2022."

Answered by AI

What are the fundamental aims of this clinical exploration?

"The primary outcome being assessed in this clinical trial is the Mean System Usability Score (SUS). Secondary measurements include changes to sleep quality, participant adherence to placebo supplement intake and Fitbit-recorded sleep duration. The latter two values will be calculated as proportions of days adherent across all participants with respective means and standard deviations provided. Changes to sleep quality over time are evaluated via Generalized Linear Mixed Model analyses while within-participant differences in Fitbit device recorded sleep duration are evaluated similarly. Assessments take place 14 weeks after baseline results have been reported back to the patient."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
New York
How old are they?
18 - 65
What site did they apply to?
Institute of Health System Science
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Feasibility Study of Personalized Trials to Improve Sleep Quality
2022. "Feasibility Study of Personalized Trials to Improve Sleep Quality". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05349188.
~26 spots leftby Sep 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top