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Clinical Trials/NCT07317349
NCT07317349
Recruiting
Not Applicable

The Effect of a Continuous 1-Hour Time Delay on Circadian Rhythms

University of Aarhus1 site in 1 country40 target enrollmentStarted: December 20, 2025Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
40
Locations
1
Primary Endpoint
Phase shift in circadian rhythm markers

Overview

Brief Summary

The purpose of this study is to investigate whether the experience of a daily time delay can affect our internal circadian rhythm.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Masking Description

Open-label, single-group basic science study; no masking used.

Eligibility Criteria

Ages
23 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Fixed daily routine

Experimental

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

Intervention: Fixed daily routine (Behavioral)

Daily time delay of 1 hour

Experimental

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

Intervention: Daily time delay (Behavioral)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Psychomotor Vigilance Task (PVT) Median Reaction Time(Performance will be measured at regular intervals on days 1 - 5 to track changes over the course of the study.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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