Melatonin Group for Circadian Rhythm Disorders

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Circadian Rhythm Disorders+3 More
Phillips Actiwatch Spectrum Plus - Device
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This study will evaluate the impact of sleep, circadian health and melatonin on flu vaccine immunogenicity.

Eligible Conditions
  • Circadian Rhythm Disorders
  • Vaccine Response
  • Sleep

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: 14-21 days post vaccination

14-21 days post vaccination
Actigraph data
Anti-influenza antibody titers
Cell-mediated immunity
Chronotype survey - Munich ChronoType Questionaire (MCTQ)
Sleep survey - Pittsburgh Sleep Quality Index (PSQI)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Control Group
1 of 2
Melatonin Group
1 of 2
Active Control
Experimental Treatment

200 Total Participants · 2 Treatment Groups

Primary Treatment: Melatonin Group · No Placebo Group · N/A

Melatonin GroupExperimental Group · 2 Interventions: Phillips Actiwatch Spectrum Plus, Melatonin · Intervention Types: Device, DietarySupplement
Control Group
Device
ActiveComparator Group · 1 Intervention: Phillips Actiwatch Spectrum Plus · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melatonin
2014
Completed Phase 4
~1150

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 14-21 days post vaccination

Who is running the clinical trial?

Naval Medical Research CenterLead Sponsor
30 Previous Clinical Trials
2,540 Total Patients Enrolled
Walter Reed National Military Medical CenterFED
125 Previous Clinical Trials
35,919 Total Patients Enrolled
Janine Danko, MDPrincipal InvestigatorNaval Medical Research Center

Eligibility Criteria

Age 18 - 65 · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are eligible to receive flu vaccination.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 4th, 2021

Last Reviewed: October 18th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.