Recruiting NCT07317349
The Effect of a Continuous 1-Hour Time Delay on Circadian Rhythms
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 →
Unsure about the terms? Read our patient guide →
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