Effects of Afternoon and Evening Light on Teenagers' Melatonin Levels, Alertness, Sleepiness and Sleep

NCT ID: NCT05483296

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-22

Study Completion Date

2023-06-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Many teenagers are familiar with this: on school days, they have to get up early; during the day, they hardly get any light exposure; in the evening, they go to bed late - and are then tired at school the next day! Around the world, teenagers are sleep deprived, with studies suggesting that almost half (\~45%) suffer from inadequate sleep. Previous investigations have shown that people's sleep-wake rhythm is related to the light conditions that they are exposed to during the day and at night. However, little is known about how different light levels in the afternoon can modulate teenagers' sleep and their bodily responses to light in the late evening. Therefore, the investigators aim to study which lighting conditions have a favourable effect on these aspects and how the potentially harmful effects of light at night can be prevented.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Light exposure during adolescence seems to be the critical component of a vicious circle. Due to the maturation of sleep-wake regulatory systems in combination with progressively ill-timed exposure to light and early school start times, teenagers suffer from the accumulation of sleep depth during school days. Therefore, the proposed study investigates whether the physiological and alerting effects of late evening light exposure in adolescents depend on the intensity of light exposure in the preceding afternoon (primary endpoint: evening melatonin concentration).

The investigators aim to describe dose-response relationships, where the "dose" is the preceding (real-world applicable) afternoon light intensity (\< 10 lx, \~100 lx, or \>1000 lx EDI, 4-hour duration), and the "responses" are the adolescents' physiological and alerting responses to evening light exposure (\~100 lx melanopic EDI, 4.5-hour duration). By this route, the researchers can explore whether increasing afternoon light exposure is a feasible target for ameliorating the detrimental effects of artificial light at night and promoting healthier sleep-wake regulation during adolescence.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Teenager Healthy Lifestyle

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The protocol is a full within-subject trial (cross-over). All participants will conduct three 18-hour experiment sessions and go through the same protocol except for the sequence of the experiment sessions (counter-balanced and randomised).
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Entirely blinding the differences between the experiment's light conditions is unattainable (for both participants and experimenters) because of the visibly perceivable differences in brightness between them. However, the melatonin and objective EEG measurements should not be significantly affected by any expectancy effects. Participants will not be told the expected effects of the different light exposure conditions to minimise the expectancy effects for behavioural measures (i.e., PVT) and subjective measurements. Information on the hypothesized outcomes will be withheld from the volunteers and study helpers until after completing all sessions. During the analysis, light intensity conditions and participant IDs will be coded to withhold information from the analytic team about the light intensity.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Crossover sequence 1: Dim, Moderate, Bright

All participants will go through all three light conditions in the three experiment sessions: They will receive white fluorescent overhead light (given in melanopic EDI at eye level) as the 4h afternoon light intervention. In the first experimental session, they receive an intensity of \<10 lx. In the second experimental session, they receive an intensity of \~100 lx, and in the third experimental session, they receive an intensity of \>1000 lx.

Group Type EXPERIMENTAL

Dim light condition

Intervention Type OTHER

During the "Dim" light condition, the four-hour afternoon light exposure at the participants' eye level will be dim (\<5 lx melanopic EDI). In the 4.5-hour evening light exposure, this will constitute a light intensity of \~100 lx melanopic EDI at the participants' eye level.

Moderate light condition

Intervention Type OTHER

During the "Moderate" light condition, the four-hour afternoon light exposure at the participants' eye level will be dim (\~100 lx melanopic EDI). In the 4.5-hour evening light exposure, this will constitute a light intensity of \~100 lx melanopic EDI at the participants' eye level.

Bright light condition

Intervention Type OTHER

During the "Bright" light condition, the four-hour afternoon light exposure at the participants' eye level will be dim (\>1000 lx melanopic EDI). In the 4.5-hour evening light exposure, this will constitute a light intensity of \~100 lx melanopic EDI at the participants' eye level.

Crossover sequence 2: Dim, Bright, Moderate

All participants will go through all three light conditions in the three experiment sessions: They will receive white fluorescent overhead light (given in melanopic EDI at eye level) as the 4h afternoon light intervention. In the first experimental session, they receive an intensity of \<10 lx. In the second experimental session, they receive an intensity of \>1000 lx, and in the third experimental session, they receive an intensity of \~100 lx.

Group Type EXPERIMENTAL

Dim light condition

Intervention Type OTHER

During the "Dim" light condition, the four-hour afternoon light exposure at the participants' eye level will be dim (\<5 lx melanopic EDI). In the 4.5-hour evening light exposure, this will constitute a light intensity of \~100 lx melanopic EDI at the participants' eye level.

Moderate light condition

Intervention Type OTHER

During the "Moderate" light condition, the four-hour afternoon light exposure at the participants' eye level will be dim (\~100 lx melanopic EDI). In the 4.5-hour evening light exposure, this will constitute a light intensity of \~100 lx melanopic EDI at the participants' eye level.

Bright light condition

Intervention Type OTHER

During the "Bright" light condition, the four-hour afternoon light exposure at the participants' eye level will be dim (\>1000 lx melanopic EDI). In the 4.5-hour evening light exposure, this will constitute a light intensity of \~100 lx melanopic EDI at the participants' eye level.

Crossover sequence 3: Moderate, Dim, Bright

All participants will go through all three light conditions in the three experiment sessions: They will receive white fluorescent overhead light (given in melanopic EDI at eye level) as the 4h afternoon light intervention. In the first experimental session, they receive an intensity of \~100 lx. In the second experimental session, they receive an intensity of \<10 lx, and in the third experimental session, they receive an intensity of \>1000 lx.

Group Type EXPERIMENTAL

No interventions assigned to this group

Crossover sequence 4: Moderate, Bright, Dim

All participants will go through all three light conditions in the three experiment sessions: They will receive white fluorescent overhead light (given in melanopic EDI at eye level) as the 4h afternoon light intervention. In the first experimental session, they receive an intensity of \~100 lx. In the second experimental session, they receive an intensity of \>1000 lx, and in the third experimental session, they receive an intensity of \<10 lx.

Group Type EXPERIMENTAL

No interventions assigned to this group

Crossover sequence 5: Bright, Moderate, Dim

All participants will go through all three light conditions in the three experiment sessions: They will receive white fluorescent overhead light (given in melanopic EDI at eye level) as the 4h afternoon light intervention. In the first experimental session, they receive an intensity of \>1000 lx. In the second experimental session, they receive an intensity of \~100 lx, and in the third experimental session, they receive an intensity of \<10 lx.

Group Type EXPERIMENTAL

No interventions assigned to this group

Crossover sequence 6: Bright, Dim, Moderate

All participants will go through all three light conditions in the three experiment sessions: They will receive white fluorescent overhead light (given in melanopic EDI at eye level) as the 4h afternoon light intervention. In the first experimental session, they receive an intensity of \>1000 lx. In the second experimental session, they receive an intensity of \<10 lx, and in the third experimental session, they receive an intensity of \~100 lx.

Group Type EXPERIMENTAL

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dim light condition

During the "Dim" light condition, the four-hour afternoon light exposure at the participants' eye level will be dim (\<5 lx melanopic EDI). In the 4.5-hour evening light exposure, this will constitute a light intensity of \~100 lx melanopic EDI at the participants' eye level.

Intervention Type OTHER

Moderate light condition

During the "Moderate" light condition, the four-hour afternoon light exposure at the participants' eye level will be dim (\~100 lx melanopic EDI). In the 4.5-hour evening light exposure, this will constitute a light intensity of \~100 lx melanopic EDI at the participants' eye level.

Intervention Type OTHER

Bright light condition

During the "Bright" light condition, the four-hour afternoon light exposure at the participants' eye level will be dim (\>1000 lx melanopic EDI). In the 4.5-hour evening light exposure, this will constitute a light intensity of \~100 lx melanopic EDI at the participants' eye level.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy
* Capable of judgment
* Normal BMI (Age-related Body-Mass-Index Percentile \> P3 \& \< P97; approx. corresponding to 28.5 ≥ BMI ≤ 16)
* Signed consent form of participants
* Signed consent form of a legal representative

Exclusion Criteria

* Pregnancy or breastfeeding (only female)
* Current participation in other clinical trials
* Extreme chronotype (Extreme early or late chronotype/mid sleep time: mid-sleep time \< 1:00 / \> 7:00)
* Extremely short or long sleep durations during school- or work days (\< 6 hours \> 11 hours)
* Sleep disorders
* High myopia (\< -6 diopters)
* High hyperopia (\> +6 diopters)
* Non-normal best-corrected visual acuity (BCVA \< 0.5 \[20/40\])
* General health concerns or disorders, including heart and cardiovascular, neurological, nephrological, endocrinological, and psychiatric conditions
* Ophthalmological or optometric conditions
* Medication impacting visual, neuroendocrine, sleep, and circadian physiology
* Drug and alcohol use (urinary drug screening \& breathalyzer test)
* Non-compliance with sleep-wake times: \>1 deviation from ±60 minute window sleep and wake-up time
* Non-compliance with caffeine intake (\> 1 times caffeine intake)
* 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
Minimum Eligible Age

14 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Psychiatric Clinics Basel

NETWORK

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr Christian Cajochen

Principal Investigator/ Sponsor-Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christian Cajochen, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre for Chronobiology, University Psychiatric Clinics Basel, Basel, Switzerland

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Psychiatric University Clinics (UPK), Centre for Chronobiology

Basel, Canton of Basel-City, Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

References

Explore related publications, articles, or registry entries linked to this study.

Galland BC, Short MA, Terrill P, Rigney G, Haszard JJ, Coussens S, Foster-Owens M, Biggs SN. Establishing normal values for pediatric nighttime sleep measured by actigraphy: a systematic review and meta-analysis. Sleep. 2018 Apr 1;41(4). doi: 10.1093/sleep/zsy017.

Reference Type BACKGROUND
PMID: 29590464 (View on PubMed)

Hagenauer MH, Perryman JI, Lee TM, Carskadon MA. Adolescent changes in the homeostatic and circadian regulation of sleep. Dev Neurosci. 2009;31(4):276-84. doi: 10.1159/000216538. Epub 2009 Jun 17.

Reference Type BACKGROUND
PMID: 19546564 (View on PubMed)

Lo JC, Lee SM, Lee XK, Sasmita K, Chee NIYN, Tandi J, Cher WS, Gooley JJ, Chee MWL. Sustained benefits of delaying school start time on adolescent sleep and well-being. Sleep. 2018 Jun 1;41(6):zsy052. doi: 10.1093/sleep/zsy052.

Reference Type BACKGROUND
PMID: 29648616 (View on PubMed)

Santhi N, Ball DM. Applications in sleep: How light affects sleep. Prog Brain Res. 2020;253:17-24. doi: 10.1016/bs.pbr.2020.05.029. Epub 2020 Jul 25.

Reference Type BACKGROUND
PMID: 32771123 (View on PubMed)

Akerstedt T, Gillberg M. Subjective and objective sleepiness in the active individual. Int J Neurosci. 1990 May;52(1-2):29-37. doi: 10.3109/00207459008994241.

Reference Type BACKGROUND
PMID: 2265922 (View on PubMed)

Gabel V, Kass M, Joyce DS, Spitschan M, Zeitzer JM. Auditory psychomotor vigilance testing in older and young adults: a revised threshold setting procedure. Sleep Breath. 2019 Sep;23(3):1021-1025. doi: 10.1007/s11325-019-01859-7. Epub 2019 May 8.

Reference Type BACKGROUND
PMID: 31069648 (View on PubMed)

Spitschan M, Woelders T. The Method of Silent Substitution for Examining Melanopsin Contributions to Pupil Control. Front Neurol. 2018 Nov 27;9:941. doi: 10.3389/fneur.2018.00941. eCollection 2018.

Reference Type BACKGROUND
PMID: 30538662 (View on PubMed)

Parrott AC, Hindmarch I. The Leeds Sleep Evaluation Questionnaire in psychopharmacological investigations - a review. Psychopharmacology (Berl). 1980;71(2):173-9. doi: 10.1007/BF00434408.

Reference Type BACKGROUND
PMID: 6777817 (View on PubMed)

Chellappa SL, Munch M, Blatter K, Knoblauch V, Cajochen C. Does the circadian modulation of dream recall modify with age? Sleep. 2009 Sep;32(9):1201-9. doi: 10.1093/sleep/32.9.1201.

Reference Type BACKGROUND
PMID: 19750925 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022-00432

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Teen Sleep Health Study
NCT04087603 COMPLETED NA