- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07317349
The Effect of a Continuous 1-Hour Time Delay on Circadian Rhythms
January 14, 2026 updated by: University of Aarhus
The purpose of this study is to investigate whether the experience of a daily time delay can affect our internal circadian rhythm.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ali Amidi, PhD
- Phone Number: +4587165305
- Email: ali@psy.au.dk
Study Contact Backup
- Name: Alisha Guyett, PhD
- Email: alisha.guyett@psy.au.dk
Study Locations
-
-
-
Aarhus, Denmark, 8000
- Recruiting
- Aarhus University, Department of Psychology and Behavioural Sciences
-
Contact:
- Alisha Guyett Guyett, PhD
- Phone Number: +4587152078
- Email: alisha.guyett@psy.au.dk
-
Sub-Investigator:
- Ali Amidi, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria
- Healthy adults aged 23-45 years
- Part of a heterosexual, cohabiting couple willing to participate together in a five-day in-laboratory study
- Both partners meet all inclusion criteria
- Completion of at least upper-secondary education
- Maintain a regular sleep-wake schedule
- Habitual sleep timing within a normative range (non-extreme chronotype), assessed using the Morningness-Eveningness Questionnaire (MEQ) or the Munich Chronotype Questionnaire (MCTQ)
- Both partners fall within the acceptable chronotype range to ensure aligned sleep-wake patterns
- Low seasonality scores on the Seasonal Pattern Assessment Questionnaire (SPAQ)
- Free from underlying sleep or mood disorders
Exclusion Criteria
- Engages in night-shift work or maintains an irregular work or sleep schedule
- International travel involving a time-zone change of more than two hours within the past two months, or anticipated travel before study completion
- Diagnosed neurological, psychiatric, or sleep disorder (e.g., insomnia, sleep apnea, bipolar disorder)
- High risk of sleep apnea, defined as a Berlin Questionnaire score >2 (Lauritzen et al., 2018)
- Use of medications known to affect sleep, alertness, melatonin secretion, or circadian timing
- Unable or unwilling to comply with behavioral restrictions, including refraining from electronic devices displaying time cues unless clocks are removed and devices are disconnected from Wi-Fi
- Unable or unwilling to comply with consumption restrictions, including abstaining from caffeine, alcohol, and melatonin-rich foods during the study
- Extreme chronotype, defined as a habitual midsleep time outside 03:00-05:00 on the MCTQ or classification as an extreme morning or extreme evening type on the MEQ
- Daily caffeine consumption exceeding 400 mg (approximately 4-5 cups of coffee)
- Current smoker or smoking within the past six months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Fixed daily routine
All activities occur at the same time every day.
During the five days, participants will have to complete various daily tests and also be asked to provide 8 saliva samples during days 1, 3, and 5
|
All activities occur at the same time every day
|
|
Experimental: Daily time delay of 1 hour
All activities will be delayed by one hour.
During the five days, participants will have to complete various daily tests and also be asked to provide 8 saliva samples during days 1, 3, and 5
|
All activities will be delayed by one hour per day over a 5 day period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Phase shift in circadian rhythm markers
Time Frame: Comparing samples on days 1, 3, 5
|
The primary outcome is the timing of dim light melatonin onset, a marker of circadian phase.
Saliva samples will be collected at regular intervals under dim light, and the time when melatonin exceeds 3 pg/mL will be recorded for each participant.
This allows measurement of circadian phase shifts across conditions.
|
Comparing samples on days 1, 3, 5
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychomotor Vigilance Task (PVT) Median Reaction Time
Time Frame: Performance will be measured at regular intervals on days 1 - 5 to track changes over the course of the study.
|
Median reaction time (milliseconds) on a brief psychomotor vigilance task (PVT) six times each day.
Participants respond as quickly as possible to visual stimuli presented at random inter-stimulus intervals.
For each block, the median reaction time is computed; additional indices such as lapses (responses > 500 ms) may be derived.
Changes in PVT performance across the the 5 days are analysed in relation to circadian phase.
|
Performance will be measured at regular intervals on days 1 - 5 to track changes over the course of the study.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
December 20, 2025
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
August 30, 2027
Study Registration Dates
First Submitted
December 19, 2025
First Submitted That Met QC Criteria
December 19, 2025
First Posted (Estimated)
January 5, 2026
Study Record Updates
Last Update Posted (Estimated)
January 16, 2026
Last Update Submitted That Met QC Criteria
January 14, 2026
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1-10-72-143-25
- 10.46540/425600108B (Other Grant/Funding Number: Independent Research Fund Denmark)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified individual participant data (IPD) underlying the published results will be shared with other researchers upon reasonable request, in accordance with Danish data protection regulations, institutional policies, and ethics approval.
Data will be pseudonymised before sharing and no direct identifiers (e.g., name, contact details, personal ID numbers) will be included.
Any data elements that could reasonably lead to re-identification in combination with other information will be removed or aggregated where necessary.
IPD Sharing Time Frame
De-identified individual participant data and supporting documents will be made available beginning within 12 months after publication of the main results article and will remain available for at least 5 years thereafter.
IPD Sharing Access Criteria
De-identified individual participant data (IPD), together with the study protocol, statistical analysis plan, and analytic code, will be available to qualified researchers affiliated with recognised research institutions who submit a methodologically sound proposal and obtain any required ethical or institutional approvals.
Requests should describe the planned analyses and data needed.
Approved requesters will sign a data use agreement prohibiting re-identification of participants and requiring appropriate data security.
Data will be shared via secure transfer or a controlled-access repository approved by Aarhus University.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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