Recruiting

Observational Study

Sponsor:

University of Arizona

Code:

NCT05382923

Conditions

Circadian Rhythm Sleep Disorder, Jet Lag Type

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Bright Light

Bright Light + Exercise + Melatonin

Control

Study Details

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

Study ID

NCT05382923

Start date

Jul 10, 2021

Status verified date

May, 2022

Completion date

May, 2023

Anticipated

Primary completion date

May, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

(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.

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Bright Light Alone

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.

experimental: Bright Light + Exercise + Melatonin

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.

placebo comparator: Placebo Control

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.

Interventions

Bright Light

3 consecutive days of 1 hour bright light

Bright Light + Exercise + Melatonin

3 consecutive days of bright light, exercise, and melatonin

Control

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

Primary outcome measure

  • Change (shift) in the acrophase of urinary 6-sulphatoxymelatonin (aMT6s) excretion [ Time Frame: 6.5 days ]
  • Change (shift) in the acrophase of the rhythm of the median reaction time [ Time Frame: 6.5 days ]
  • Change in sleep duration [ Time Frame: 5 days ]

Central Contacts and Locations

Central contacts

Shawn Youngstedt, PhD

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

Salma Patel, MD

480-768-7880salmapatel@arizona.edu

Locations

Center Sleep and Circadian Sciences

Recruiting

Tucson, Arizona, United States, 85724

Contacts

Sairam Parthasarethy, MD

sparthasarathy@deptofmed.arizona.edu

More Information

Sponsor

University of Arizona

Last update posted

May 19, 2022

Last verified

May, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2022-05-19.