Facilitating Adjustment to Simulated Jet Lag

NCT05382923 | Unknown

• 1 other identifier: 2011240758
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this study are to compare 3 different treatments for circadian adjustment to a laboratory protocol which will mimic westward air travel across 8 time zones. One treatment will involve simply following the new schedule for 3 days. Another treatment will also involve exposure to bright light for 1 hour per day. A third treatment will involve exposure to bright light + exercise for 1 hour per day + consuming a melatonin tablet. Adjustment to the shifted schedule will be assessed by comparing measures of sleep, mood, mental performance, physical performance, and timing of melatonin across the 3 treatment conditions.

Conditions

Circadian Rhythm Sleep Disorder, Jet Lag Type

Outcome Measures

Primary Outcomes (3)

• Change (shift) in the acrophase of urinary 6-sulphatoxymelatonin (aMT6s) excretion

  Change (shift) in the cosine fitted peak for the assessments (every 90 min) during lab days 2-3 compared with the assessments taken during days 6-7

  6.5 days

• Change (shift) in the acrophase of the rhythm of the median reaction time

  Change (shift) in the cosine fitted peak for the assessments (psychomotor vigilance, every 3 h) taken during days 2-3 compared with the assessments taken during days 6-7

  6.5 days

• Change in sleep duration

  Change in total sleep time assessed during night one in the lab and night 5 in the lab duration

  5 days

Secondary Outcomes (4)

• Change (shift) in the acrophase of the Total Mood Disturbance composite scale of on the Profile of Mood States questionnaire

  5 days

• Change (shift) in the acrophase of the Stanford Sleepiness Scale

  5 days

• Change (shift) in the acrophase of the Wingate Anaerobic Performance Test

  5 days

• Change in sleep recorded with z-machine

  5 days

Study Arms (3)

Bright Light Alone

EXPERIMENTAL

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.

Behavioral: Bright Light

Bright Light + Exercise + Melatonin

EXPERIMENTAL

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.

Behavioral: Bright Light + Exercise + Melatonin

Placebo Control

PLACEBO COMPARATOR

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.

Behavioral: Control

Interventions

Bright Light BEHAVIORAL

3 consecutive days of 1 hour bright light

Also known as: Bright Light Treatment

Bright Light Alone

Bright Light + Exercise + Melatonin BEHAVIORAL

3 consecutive days of bright light, exercise, and melatonin

Also known as: Bright Light Treatment + Treadmill Exercise + Melatonin

Bright Light + Exercise + Melatonin

Control BEHAVIORAL

3 consecutive days of dim red light + light stretching + placbo

Also known as: Placebo Control

Placebo Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age 18-45 years
• At least moderate level of habitual physical activity (twice per week, 20 min of aerobic exercise at 60% of maximal effort or higher

You may not qualify if:

• (1)Having more than one risk factor for coronary artery disease: (2) having any symptom or sign of cardiopulmonary disease; (3) recent shift-work experience (previous 2 months) or travel across multiple time zones (previous 4 weeks); (4) having an abnormal sleep-wake schedule (i.e., reported bedtime before 9:00 pm or after 2:00 am; wake time before 5:00 am or after 10:00 am); (5) being an extreme night owl or morning lark, as assessed by the Horne-Ostberg Mornngness-Eveningness Scale;70 (6) having a high risk sleep apnea or another sleep disorder; (7) depressed mood \[Center for Epidemiologic Studies-Depression Scale (CES-D) \> 16\];71 (7) use of medications likely to distort melatonin excretion or cardiovascular responses to exercise; (8) use of sleeping pills more than 1 night per week; (9) having high sensitivity to light; (10) abuse of alcohol or drugs (amount per week; related problems such as missing work); (11) any physical or mental health condition that would contraindicate participation in exercise or other rigors of the experiment.

Sponsors & Collaborators

• University of Arizona: lead
• University of California, San Diego: collaborator

Study Sites (1)

Center Sleep and Circadian Sciences

Tucson, Arizona, 85724, United States

RECRUITING

MeSH Terms

Conditions

Jet Lag Syndrome

Interventions

Exercise; Melatonin

Condition Hierarchy (Ancestors)

Chronobiology Disorders; Nervous System Diseases; Sleep Disorders, Circadian Rhythm; Dyssomnias; Sleep Wake Disorders; Travel-Related Illness; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Shawn Youngstedt, PhD

  Univ Arizona

  PRINCIPAL INVESTIGATOR

• Salma Patel, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shawn Youngstedt, PhD

CONTACT

803-767-3208; youngstedt@email.arizona.edu

Salma Patel, MD

CONTACT

480-768-7880; salmapatel@arizona.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are informed that we are exploring different types of stimuli (including exercise, melatonin, and light) to help adjust to simulated jet lag.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Random assignment to one of three conditions

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: May 19, 2022
• Study Start: July 10, 2021
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)