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Facilitating Adjustment to Simulated Jet Lag
N/A
Waitlist Available
Led By Shawn Youngstedt, PhD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6.5 days
Summary
This trial tests three methods to help young adults adjust to a significant time zone shift. The methods include following a new schedule, adding bright light exposure, and combining bright light, exercise, and melatonin. The goal is to see which method best improves sleep, mood, and performance.
Eligible Conditions
- Jet Lag
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6.5 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6.5 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 moreTrial 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
539 Previous Clinical Trials
161,640 Total Patients Enrolled
University of California, San DiegoOTHER
1,189 Previous Clinical Trials
1,587,705 Total Patients Enrolled
Shawn Youngstedt, PhDPrincipal InvestigatorUniv Arizona
Salma Patel, MDPrincipal InvestigatorUniversity of Arizona