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Bright Light + Exercise + Melatonin for Jet Lag

N/A
Recruiting
Led By Salma Patel, MD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least moderate level of habitual physical activity (twice per week, 20 min of aerobic exercise at 60% of maximal effort or higher
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6.5 days
Awards & highlights

Study Summary

This trial will compare the efficacy of three different treatments for circadian adjustment to a laboratory protocol simulating westward air travel.

Eligible Conditions
  • Jet Lag

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You exercise at least twice a week for 20 minutes at a moderate to intense level.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6.5 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6.5 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change (shift) in the acrophase of the rhythm of the median reaction time
Change (shift) in the acrophase of urinary 6-sulphatoxymelatonin (aMT6s) excretion
Change in sleep duration
Secondary outcome measures
Change (shift) in the acrophase of the Stanford Sleepiness Scale
Change (shift) in the acrophase of the Total Mood Disturbance composite scale of on the Profile of Mood States questionnaire
Change (shift) in the acrophase of the Wingate Anaerobic Performance Test
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Bright Light AloneExperimental Treatment1 Intervention
Bright light administered with Re-Timer glasses for 1 hour on 3 consecutive days. Following the 8 hour delay of the light/dark and sleep/wake cycle in the laboratory, the light will be administered, on average at 5:30-6:30 pm, 7:00-8:00 pm, and 9:30-10:30 pm, respectively on these three days.
Group II: Bright Light + Exercise + MelatoninExperimental Treatment1 Intervention
Bright light will be administered with Re-Timer glasses for 1 hour on 3 consecutive days. Following the 8 hour delay of the light/dark and sleep/wake cycle in the laboratory, the light will be administered, on average at 5:30-6:30 pm, 7:00-8:00 pm, and 9:30-10:30 pm, respectively on these three days. Exercise (1 hour at 65-75% heart rate reserve) will be administered on 3 consecutive, at 1:30-2:30 pm, 4:00-5:00 pm, and 6:30-7:30 pm on these days. Melatonin (0.5 mg) will be administered at 6 am, 8:30 am, and 11:00, on the 3 days.
Group III: Placebo ControlPlacebo Group1 Intervention
Dim red light will be administered with Re-Timer glasses for 1 hour on 3 consecutive days. Following the 8 hour delay of the light/dark and sleep/wake cycle in the laboratory, the light will be administered, on average at 5:30-6:30 pm, 7:00-8:00 pm, and 9:30-10:30 pm, respectively on these three days. Placebo tablets (0.5 mg) will be administered at 6 am, 8:30 am, and 11:00, on the 3 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bright Light
2013
N/A
~120

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor
508 Previous Clinical Trials
147,812 Total Patients Enrolled
University of California, San DiegoOTHER
1,108 Previous Clinical Trials
1,854,765 Total Patients Enrolled
Salma Patel, MDPrincipal InvestigatorUniversity of Arizona

Frequently Asked Questions

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

Are there any prospective participants being registered for this experiment?

"Affirmative. As evidenced on clinicaltrials.gov, this research study is currently seeking candidates to participate in their trial which was first made available for enrollment on July 10th 2021 and last updated on May 16th 2022. A total of 36 patients are necessary at a single site."

Answered by AI

Who is qualified to become a participant in this trial?

"This clinical trial is looking to procure 36 patients who suffer from jet lag syndrome and are between 18-45 years old."

Answered by AI

What is the desired outcome of this clinical research endeavor?

"As the primary outcome, this medical trial will measure changes in sleep duration over a 6.5 day period. Secondary objectives include assessing z-machine recorded restorative slumber, analysing shifts in total mood disturbance on days 2-3 and 6-7 as per Profile of Mood States questionnaire data, plus ascertaining any alterations to peak Wingate Anaerobic Performance Test performance between days 2-3 and 6-7."

Answered by AI

How many participants has the clinical trial enrolled thus far?

"Affirmative, clinicaltrials.gov indicates that this medical trial is actively searching for participants as of the last update on May 16th 2022; with a total of 36 individuals to be recruited from one location. This study was originally posted online on July 10th 2021."

Answered by AI

Is enrollment limited to participants below thirty years of age?

"The parameters of this study necessitate that all participants be between the ages of 18 and 45. Conversely, there are 23 trials specifically for minors and 61 clinical trials targeted towards seniors over 65 years old."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Center Sleep and Circadian Sciences
~10 spots leftby Feb 2025