NCT07294781

Brief Summary

This study examines how the internal body clock (circadian rhythms) influences the way healthy adults experience time, think, and feel when they stay awake for an extended period. Participants will spend about 36 hours in a controlled sleep laboratory while remaining awake the entire time. Light, posture, food intake, and activity are kept as constant as possible (a "constant routine") so that changes over time mainly reflect the body's internal clock and increasing sleepiness, rather than changes in the environment. Every two hours, participants complete a brief test battery that includes ratings of sleepiness and mood, a reaction-time task, and short tasks that assess how fast or slow time seems to pass, how accurately they can estimate time intervals, how they respond to simple decisions, and how they judge colours. Saliva samples are collected repeatedly to measure melatonin, a hormone that indicates circadian phase. By comparing changes in behaviour, perception, and melatonin levels across the 36-hour wake period, the study aims to identify when during the circadian cycle people are most vulnerable to distortions in time perception and reduced alertness. The findings may help improve scheduling of shift work and other activities that require sustained wakefulness.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started Dec 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Dec 2025Dec 2027

Study Start

First participant enrolled

December 5, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 19, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

2.1 years

First QC Date

December 8, 2025

Last Update Submit

December 19, 2025

Conditions

Keywords

Circadian rhythmsConstant routineExtended wakefulnessSleep lossTime perceptionSubjective timePsychomotor vigilance taskDim light melatonin onsetHealthy adults

Outcome Measures

Primary Outcomes (1)

  • Time-Interval Production Error Across 36-Hour Constant Routine

    Mean absolute error (in seconds) between produced and target time intervals on a time-production task. Participants are asked to produce predefined intervals (e.g., several seconds) without external timing cues. For each 2-hour block, time-production error is averaged across trials; analyses model changes in error across circadian phase and hours awake during the 36-hour constant routine.

    From the beginning of the constant-routine wakefulness session through 36 hours of continuous wakefulness (time-production task completed every 2 hours).

Secondary Outcomes (3)

  • Subjective Passage-of-Time Ratings Across 36-Hour Constant Routine

    From the beginning of the constant-routine wakefulness session through 36 hours of continuous wakefulness (passage-of-time ratings completed every 2 hours).

  • Psychomotor Vigilance Task (PVT) Median Reaction Time

    From the beginning of the constant-routine wakefulness session through 36 hours of continuous wakefulness (PVT completed every 2 hours).

  • Dim Light Melatonin Onset (DLMO) Timing

    During the 36-hour constant-routine wakefulness session (salivary melatonin sampled approximately hourly).

Study Arms (1)

Constant Routine Wakefulness

OTHER

Single-group 36-hour constant-routine protocol with continuous wakefulness. Participants remain in a controlled laboratory environment under low, constant light, with restricted posture and activity, and receive small isocaloric snacks at fixed intervals. Every two hours they complete a standardised test battery assessing time perception, vigilance, mood, and related cognitive and perceptual outcomes.

Behavioral: Constant Routine Wakefulness

Interventions

Behavioral intervention consisting of approximately 36 hours of continuous wakefulness under constant-routine conditions. Environmental factors (light level, temperature, noise) are held as constant as feasible; posture and activity are standardised; and participants receive small, isocaloric snacks at regular intervals. A repeated cognitive and perceptual test battery is administered every two hours to assess time perception, vigilance, mood, and related functions across the circadian cycle.

Constant Routine Wakefulness

Eligibility Criteria

Age23 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 23 to 45 years.
  • Able and willing to provide written informed consent.
  • Fluent in Danish and able to understand study procedures and instructions.
  • Generally healthy, as assessed by medical history, screening questionnaires, and basic clinical measures (e.g., blood pressure, heart rate).
  • Self-reported regular sleep-wake schedule for at least 4 weeks prior to the laboratory visit (typically 6.5-9 hours of sleep per night, with usual sleep period between approximately 22:00-01:00 and 06:00-09:00).
  • Body mass index (BMI) within a non-extreme range (for example, approximately 18.5-30 kg/m²), if required by the study physician.
  • No regular night work or rotating shift work during the 3 months before participation.
  • No travel across more than 2 time zones in the 2 months before the constant-routine session.
  • Willing to abstain from caffeine, nicotine, alcohol, and recreational drugs for the specified washout periods before and during the 36-hour constant-routine session.
  • For participants who can become pregnant: negative pregnancy test at screening/arrival and agreement to use reliable contraception for the duration of participation.

You may not qualify if:

  • Any known or suspected major sleep disorder (e.g., insomnia disorder, obstructive sleep apnoea, restless legs syndrome, narcolepsy), based on self-report or prior diagnosis.
  • Current or past major psychiatric or neurological disorders (e.g., major depressive disorder, bipolar disorder, psychotic disorders, epilepsy), unless considered mild and stable and explicitly approved by the study physician.
  • Chronic medical conditions that could be worsened by prolonged wakefulness or that might confound outcome measures, such as significant cardiovascular disease, uncontrolled hypertension, diabetes mellitus, severe respiratory disease, or other serious systemic illness.
  • Regular use of medications or supplements that may affect sleep, circadian rhythms, melatonin secretion, alertness, or mood (e.g., hypnotics, sedative-hypnotics, melatonin, stimulants, certain antidepressants or beta-blockers), unless a safe washout is possible and approved by the study physician.
  • High habitual caffeine intake (for example, \>400 mg/day) or nicotine dependence if the participant is unable or unwilling to abstain for the required washout periods.
  • Current harmful alcohol use or substance use disorder, or frequent use of recreational drugs.
  • Pregnancy or breastfeeding.
  • Previous severe adverse reaction to sleep deprivation, extended wakefulness, or similar laboratory protocols.
  • Claustrophobia or inability to tolerate prolonged stays in a controlled laboratory environment.
  • Any condition or circumstance that, in the judgement of the investigators, would make participation unsafe, interfere with the 36-hour wakefulness protocol, or compromise data quality (e.g., inability to remain awake despite support, strong fear of needles or saliva sampling, or inability to comply with study restrictions).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University, Department of Psychology and Behavioural Sciences

Aarhus, 8000, Denmark

RECRUITING

Related Publications (3)

  • Kuriyama K, Uchiyama M, Suzuki H, Tagaya H, Ozaki A, Aritake S, Shibui K, Xin T, Lan L, Kamei Y, Takahashi K. Diurnal fluctuation of time perception under 30-h sustained wakefulness. Neurosci Res. 2005 Oct;53(2):123-8. doi: 10.1016/j.neures.2005.06.006.

  • Yu C, Van Zuijlen MJP, Spoiala C, Pont SC, Wijntjes MWA, Hurlbert A. Time-of-day perception in paintings. J Vis. 2024 Jan 2;24(1):1. doi: 10.1167/jov.24.1.1.

  • Hurlbert A, Yu C. Seeing the Light: Perception and Discrimination of Illumination Color. Annu Rev Vis Sci. 2025 Sep;11(1):267-301. doi: 10.1146/annurev-vision-121423-013755. Epub 2025 Aug 5.

Related Links

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Central Study Contacts

Ali Amidi, PhD

CONTACT

Cehao Yu, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Open-label, single-group basic science study; no masking used.
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: All participants complete a single 36-hour constant-routine protocol with continuous wakefulness under controlled environmental conditions.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2025

First Posted

December 19, 2025

Study Start

December 5, 2025

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

December 22, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
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.
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.

Locations