Circadian Rhythm Sleep Disorder, Jet Lag TypeNCT05382923
Facilitating Adjustment to Simulated Jet Lag
A study testing Bright Light and Bright Light + Exercise + Melatonin in people with Circadian Rhythm Sleep Disorder, Jet Lag Type, run by University of Arizona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Circadian Rhythm Sleep Disorder, Jet Lag Type
- What is being tested?
- Bright Light and Bright Light + Exercise + Melatonin
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2021to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Center Sleep and Circadian Sciences
Tucson, Arizona, 85724
Sairam Parthasarethy, MD, sparthasarathy@deptofmed.arizona.edu
About this study
Official title: Circadian Acclimatization of Performance, Sleep, and 6-sulphatoxymelatonin Using Multiple Phase-Shifting Stimuli
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.
Read the 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.
- Being tested
- Bright Light, Bright Light + Exercise + Melatonin, Control
- Medical subject headings
- Jet Lag Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright LightBehavioural
Also called Bright Light Treatment
3 consecutive days of 1 hour bright light
Bright Light + Exercise + MelatoninBehavioural
Also called Bright Light Treatment + Treadmill Exercise + Melatonin
3 consecutive days of bright light, exercise, and melatonin
ControlBehavioural
Also called Placebo Control
3 consecutive days of dim red light + light stretching + placbo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
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
Measured: 5 days
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
Measured: 5 days
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.
Measured: 5 days
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
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start10 Jul 2021
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circadian Rhythm Sleep Disorder, Jet Lag TypeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Random assignment to one of three conditions
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego
- Responsible party
- Principal investigator, Shawn Youngstedt, Arizona State University
- Investigators
- Shawn Youngstedt, PhD, Principal investigator, Univ ArizonaSalma Patel, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382923
- Sponsor's protocol ID
- 2011240758
- Status last verified
- May 2022
- First submitted
- 2 Mar 2022
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: None. We will only share mean data which are de-identified
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circadian Acclimatization of Performance, Sleep, and 6-sulphatoxymelatonin Using Multiple Phase-Shifting Stimuli
- ClinicalTrials.gov ID
- NCT05382923
- Acronym / sponsor ID
- 2011240758
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- University of California, San Diego
- Study start
- 10 Jul 2021 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Random assignment to one of three conditions
| Arm | Type | Receives |
|---|---|---|
| Bright Light Alone | Experimental | Behavioral: Bright LightBright 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 + Exercise + Melatonin | Experimental | Behavioral: Bright Light + Exercise + MelatoninBright 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 Control | Placebo comparator | Behavioral: ControlDim 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bright LightAlso: Bright Light Treatment3 consecutive days of 1 hour bright light | Behavioural | Bright Light Alone |
| Bright Light + Exercise + MelatoninAlso: Bright Light Treatment + Treadmill Exercise + Melatonin3 consecutive days of bright light, exercise, and melatonin | Behavioural | Bright Light + Exercise + Melatonin |
| ControlAlso: Placebo Control3 consecutive days of dim red light + light stretching + placbo | Behavioural | Placebo Control |
Primary outcome
Change (shift) in the acrophase of urinary 6-sulphatoxymelatonin (aMT6s) excretion
Time frame: 6.5 days
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
Time frame: 6.5 days
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
Time frame: 5 days
Change in total sleep time assessed during night one in the lab and night 5 in the lab duration
4 secondary outcomes
Change (shift) in the acrophase of the Total Mood Disturbance composite scale of on the Profile of Mood States questionnaire
Time frame: 5 days
Change (shift) in the acrophase of the Stanford Sleepiness Scale
Time frame: 5 days
Change (shift) in the acrophase of the Wingate Anaerobic Performance Test
Time frame: 5 days
Change in sleep recorded with z-machine
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Individual participant dataSharing planned: No. None. We will only share mean data which are de-identified
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shawn Youngstedt, PhD principal investigator
Univ Arizona
Salma Patel, MD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright Light and Bright Light + Exercise + Melatonin in people with Circadian Rhythm Sleep Disorder, Jet Lag Type, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shawn Youngstedt, PhD (803-767-3208, youngstedt@email.arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change (shift) in the acrophase of urinary 6-sulphatoxymelatonin (aMT6s) excretion (time frame: 6.5 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.