Menu
Recruiting NCT07317349

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

No phase Interventional Circadian Rhythms Time Perception Sleep

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fixed daily routine, Daily time delay.
Who it may be relevant to
Registry conditions: Circadian Rhythms, Time Perception, Sleep. Basic parameters: 23 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Interventions

  • Behavioral Fixed daily routine
    All activities occur at the same time every day
  • Behavioral Daily time delay
    All activities will be delayed by one hour per day over a 5 day period.

Primary outcome measures

  • Phase shift in circadian rhythm markers [Time frame: Comparing samples on days 1, 3, 5]
Secondary outcome measures (1)
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

Denmark · 1 center
  • Aarhus University, Department of Psychology and Behavioural Sciences — Aarhus

Identifiers

NCT: NCT07317349 · 1-10-72-143-25 · 10.46540/425600108B

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗