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Facilitating Adjustment to Simulated Jet Lag

Primary Purpose

Circadian Rhythm Sleep Disorder, Jet Lag Type

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bright Light
Bright Light + Exercise + Melatonin
Control
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Circadian Rhythm Sleep Disorder, Jet Lag Type

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Center Sleep and Circadian SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Bright Light Alone

Bright Light + Exercise + Melatonin

Placebo Control

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change (shift) in the acrophase of the Total Mood Disturbance composite scale of on the Profile of Mood States questionnaire
Change (shift) in the cosine-fitted peak of the rhythm of total mood disturbance assessed during days 2-3 compared with total mood disturbance assessed during days 6-7
Change (shift) in the acrophase of the Stanford Sleepiness Scale
Change (shift) in the cosine-fitted peak of the rhythm of the Stanford Sleepiness Scale assessed during days 2-3 compared with the Stanford Sleepiness Scale mood disturbance assessed during days 6-7
Change (shift) in the acrophase of the Wingate Anaerobic Performance Test
Change (shift) in the cosine-fitted peak of the rhythm of the Wingate Anaerobic Performance Test assessed on days 2-3 and day 6-7.
Change in sleep recorded with z-machine
Z machine recorded sleep with electrodes on the mastoid bones. Change in sleep assessed in eight 1-h sleep intervals on days 2-3 and days 6-7

Full Information

First Posted
March 2, 2022
Last Updated
May 16, 2022
Sponsor
University of Arizona
Collaborators
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT05382923
Brief Title
Facilitating Adjustment to Simulated Jet Lag
Official Title
Circadian Acclimatization of Performance, Sleep, and 6-sulphatoxymelatonin Using Multiple Phase-Shifting Stimuli
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2021 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona
Collaborators
University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Design Overview. Following a 1 week home baseline, N=36 young adults will spend 6 days in the laboratory (Figure 3 and Table 1). Following am 8 h baseline polysomnographic recording (PSG) on Night 1, participants will undergo a 26 h baseline circadian assessment via an ultrashort sleep-wake protocol involving 2 h wake intervals and 1 h sleep intervals, repeated throughout the protocol. Following baseline circadian assessment, participants will be placed on a 16 h wake-8 h sleep schedule in which the wake-sleep and light-dark schedule is delayed 8 h for 3 days (analogous to traveling 8 time zones west). Participants will be randomized to one of 3 treatments (n=12 per treatment) administered each of the 3 days of the shifted schedule: (1) placebo control, (2) bright light, and (3) bright light + exercise + melatonin. PSG recording will occur on the last night of the shifted schedule, followed by an end-of-study 26 h ultrashort sleep wake schedule. On baseline Day 1 and Days 2-3 of the shifted schedule, sleepiness, mood, and mental performance will be assessed every 3 h during wake. During all four 8 h sleep periods, sleep will also be recorded with the Z-machine, which assesses sleep stages from 3 EEG electrodes. During the ultrashort sleep-wake schedules, mental performance, physiological performance, urinary aMT6s, mood, and sleepiness will be measured around-the-clock.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Circadian Rhythm Sleep Disorder, Jet Lag Type

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Random assignment to one of three conditions
Masking
Participant
Masking Description
Participants are informed that we are exploring different types of stimuli (including exercise, melatonin, and light) to help adjust to simulated jet lag.
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bright Light Alone
Arm Type
Experimental
Arm Description
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.
Arm Title
Bright Light + Exercise + Melatonin
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Bright Light
Other Intervention Name(s)
Bright Light Treatment
Intervention Description
3 consecutive days of 1 hour bright light
Intervention Type
Behavioral
Intervention Name(s)
Bright Light + Exercise + Melatonin
Other Intervention Name(s)
Bright Light Treatment + Treadmill Exercise + Melatonin
Intervention Description
3 consecutive days of bright light, exercise, and melatonin
Intervention Type
Behavioral
Intervention Name(s)
Control
Other Intervention Name(s)
Placebo Control
Intervention Description
3 consecutive days of dim red light + light stretching + placbo
Primary Outcome Measure Information:
Title
Change (shift) in the acrophase of urinary 6-sulphatoxymelatonin (aMT6s) excretion
Description
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
Time Frame
6.5 days
Title
Change (shift) in the acrophase of the rhythm of the median reaction time
Description
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
Time Frame
6.5 days
Title
Change in sleep duration
Description
Change in total sleep time assessed during night one in the lab and night 5 in the lab duration
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Change (shift) in the acrophase of the Total Mood Disturbance composite scale of on the Profile of Mood States questionnaire
Description
Change (shift) in the cosine-fitted peak of the rhythm of total mood disturbance assessed during days 2-3 compared with total mood disturbance assessed during days 6-7
Time Frame
5 days
Title
Change (shift) in the acrophase of the Stanford Sleepiness Scale
Description
Change (shift) in the cosine-fitted peak of the rhythm of the Stanford Sleepiness Scale assessed during days 2-3 compared with the Stanford Sleepiness Scale mood disturbance assessed during days 6-7
Time Frame
5 days
Title
Change (shift) in the acrophase of the Wingate Anaerobic Performance Test
Description
Change (shift) in the cosine-fitted peak of the rhythm of the Wingate Anaerobic Performance Test assessed on days 2-3 and day 6-7.
Time Frame
5 days
Title
Change in sleep recorded with z-machine
Description
Z machine recorded sleep with electrodes on the mastoid bones. Change in sleep assessed in eight 1-h sleep intervals on days 2-3 and days 6-7
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shawn Youngstedt, PhD
Phone
803-767-3208
Email
youngstedt@email.arizona.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Salma Patel, MD
Phone
480-768-7880
Email
salmapatel@arizona.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shawn Youngstedt, PhD
Organizational Affiliation
Univ Arizona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Salma Patel, MD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center Sleep and Circadian Sciences
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sairam Parthasarethy, MD
Email
sparthasarathy@deptofmed.arizona.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
None. We will only share mean data which are de-identified

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Facilitating Adjustment to Simulated Jet Lag

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