NCT05423002

Brief Summary

The main aim of this study is to investigate the effects of cone-modulated light emitted from a visual display on human circadian physiology and cognitive performance in the evening.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

June 20, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

9 months

First QC Date

June 7, 2022

Last Update Submit

June 14, 2022

Conditions

Light Flashing

Keywords

Flickering lightPhotoreceptorsCones

Outcome Measures

Primary Outcomes (1)

  • Melatonin concentration

    The saliva samples will be collected from participants every 30 min. The investigators hypothesize that the cone flickering light stimuli will have a different melatonin-attenuating effect than the constant background stimuli and that both will have a different effect than baseline.

    1 year

Secondary Outcomes (5)

  • Vigilance performance

    1 year

  • Subjective sleepiness

    1 year

  • Visual comfort

    1 year

  • Skin temperature

    1 year

  • Pupil response

    1 year

Study Arms (3)

Control

PLACEBO COMPARATOR

Dim light condition as a baseline

Other: Dim light

Modulation

ACTIVE COMPARATOR

Flickering light will be added sinusoidally onto the background light.

Other: Flickering light stimuli

Background

SHAM COMPARATOR

Constant light with maximum half irradiance (50%) of all primaries.

Other: Constant light stimuli

Interventions

Flickering light stimuliOTHER

The intervention will be exposed to flickering lights (≤200 lux). More specifically, the participants will be asked to be exposed to a specified flickering light (1Hz, 30 seconds On, and 30 seconds OFF) for 2 hours starting at their habitual bedtime (HBT).

Modulation
Constant light stimuliOTHER

The intervention will be exposed to constant background lights (≤200 lux). The participants will be asked to be exposed to a specified constant light for 2 hours starting at their habitual bedtime (HBT).

Background
Dim lightOTHER

This light condition is the baseline (≤10 lux).

Control

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 18 - 35 years
  • Sex: male or female normal color vision, male dichromat (i.e. tested by CCT, HRR, Farnsworth Munsell 100 Hue Test)
  • BMI: 18.5 - 29.9 self-reported weight and height (i.e. normal and overweight according to WHO)
  • Signed consent form of participants
  • Chronotype: Morningness-Eveningness Questionnaire (31 - 69)
  • Sleep Quality: Pittsburgh Sleep Quality Index, PSQI (≤5)

You may not qualify if:

  • High myopia (\> -6 diopters)
  • High hyperopia (\< +6 diopters)
  • Transmeridian travel (\>2 time zones) \<1 month prior to the first session of the study
  • Shift work \<3 months prior to the beginning of the study
  • Ophthalmological or optometric conditions (cataract, glaucoma, retinal detachment, macular conditions, chronic inflammations, eye injuries, or operations)
  • General health concerns or disorders, including heart and cardiovascular, neurological, nephrological, endocrinological, and psychiatric conditions
  • Medication impacting on visual, neuroendocrine, sleep, and circadian physiology
  • For females only: pregnancy, use of hormonal contraceptives, lactation or breastfeeding
  • Drug (urinary drug screening) and alcohol use
  • Non-compliance with sleep-wake times: \>1 deviation from ±30 minute window sleep and wake-up time
  • Extreme chronotype (Munich Chronotype Questionnaire \<2 or \>7)
  • Current participation in other clinical trials
  • Inability to understand and/or follow study materials or procedures
  • Insufficient knowledge of project language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Chronobiology

Basel, 4002, Switzerland

Location

MeSH Terms

Conditions

photopsia

Study Officials

  • Christian Cajochen, Prof

    Centre for Chronobiology, UPK, University of Basel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatemeh Fazlali, MSc

CONTACT

+41(0) 61 325 5478fatemeh.fazlali@unibas.ch

Christian Cajochen, Prof

CONTACT

+41(0) 61 325 5318Christian.Cajochen@upk.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

June 7, 2022

First Posted

June 21, 2022

Study Start

June 20, 2022

Primary Completion

March 15, 2023

Study Completion

September 15, 2023

Last Updated

June 21, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

As the investigators have a plan to submit the study to a registered report journal. The investigators would prefer to share the data after submission.

Locations

CH(1)