HealthyTeenLightNCT05483296
Effects of Afternoon and Evening Light on Teenagers' Melatonin Levels, Alertness, Sleepiness and Sleep
A study testing Dim light condition, Moderate light condition and Bright light condition in people with Healthy and Teenager, run by University Psychiatric Clinics Basel at 1 site in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Teenager, Healthy Lifestyle
- What is being tested?
- Dim light condition, Moderate light condition and Bright light condition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Sep 2022to 20 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Psychiatric University Clinics (UPK), Centre for Chronobiology
Basel, Canton of Basel-City, 4002
About this study
Official title: Modulating Evening Responses to Light by Afternoon Light Exposure in Adolescents
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.
Read the detailed description
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
- Healthy, Teenager, Healthy Lifestyle
- Being tested
- Dim light condition, Moderate light condition, Bright light condition
- Keywords
- melatonin, polysomnography, EEG, sleep, afternoon light, pupil size, evening light
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dim light conditionOther
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 conditionOther
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 conditionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Crossover sequence 1: Dim, Moderate, Bright | Experimental | 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. Receives: Other: Dim light condition; Other: Moderate light condition; Other: Bright light condition |
| Crossover sequence 2: Dim, Bright, Moderate | Experimental | 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. Receives: Other: Dim light condition; Other: Moderate light condition; Other: Bright light condition |
| Crossover sequence 3: Moderate, Dim, Bright | Experimental | 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. |
| Crossover sequence 4: Moderate, Bright, Dim | Experimental | 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. |
| Crossover sequence 5: Bright, Moderate, Dim | Experimental | 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. |
| Crossover sequence 6: Bright, Dim, Moderate | Experimental | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary melatonin
Salivary melatonin. Saliva samples (>1 mL) will be taken from the participants every 30 Minutes using Salivettes. The Salivettes will be centrifuged, the cotton part removed and immediately frozen at -20°C. At a later point, melatonin [in pg] will be determined in these samples by double-antibody radioimmunoassay (RIA). To quantify melatonin suppression, the analytic team will calculate the area under the curve (AUC) for each laboratory condition.
Measured: Through study completion, estimated 1.5 years (within 3 weeks for each participant)
Secondary outcomes (9)
Sleep Onset Latency (PSG-derived)
The investigators will operationalise Sleep Onset Latency according to the American Academy of Sleep Medicine (AASM) Manual for the Scoring of Sleep and Associated Events (time interval from lights out to the first PSG-derived sleep epoch in minutes).
Measured: Through study completion, estimated 1.5 years (within 3 weeks for each participant)
Slow wave activity (PSG-derived)
The investigators will examine slow-wave activity (SWA; delta power density between 0.5 and 4.5 Hz) during the first sleep cycle. EEG slow-wave activity (SWA) (i.e., delta power density between 0.5 and 4.5 Hz) will be calculated as an indicator of sleep propensity across the night within each non-rapid eye movement NREM part of a sleep cycle.
Measured: Through study completion, estimated 1.5 years (within 3 weeks for each participant)
Sleep stages (PSG-derived)
The investigators will score the PSG-derived sleep stages and arousals according to the American Academy of Sleep Medicine (AASM) Manual for the Scoring of Sleep and Associated Events.
Measured: Through study completion, estimated 1.5 years (within 3 weeks for each participant)
Subjective sleepiness
The investigators will assess subjective sleepiness using the single-item 9-point Karolinska Sleepiness Scale (KSS) - a well-validated, highly sensitive subjective Likert-type measurement scale for subjective sleepiness.
Scores range from 1 to 9 with higher values on the scale corresponding to higher sleepiness.
Measured: Through study completion, estimated 1.5 years (within 3 weeks for each participant)
Vigilant attention
Objective alertness will be measured using a modified auditory Psychomotor Vigilance Test (aPVT). After a response, the next tone will be played randomly after 2-10 s. The reaction time data will focus on mean 1/reaction time (mean 1/RT), the most sensitive measure for a slight deviation in sleep pressure. Mean 1/RT will be calculated after the removal of false starts and lapses.
Measured: Through study completion, estimated 1.5 years (within 3 weeks for each participant)
Melanopsin sensitivity (pupillary light response)
The investigators will measure changes in the pupil area using silent substitution pupillography and examine the differences between melanopsin response amplitude before the afternoon light condition (pre-light treatment) and the melanopsin response amplitude after the afternoon light condition (post-light treatment).
Measured: Through study completion, estimated 1.5 years (within 3 weeks for each participant)
Skin temperature
Skin temperature will be continuously monitored with six surface temperature thermocouples placed on proximal and distal regions of the body surface. Skin temperatures (distal \& proximal) and the distal-proximal skin temperature gradient (DPG) will be calculated.
Measured: Through study completion, estimated 1.5 years (within 3 weeks for each participant)
Objective sleepiness 1
The volunteers will perform a Karolinska Drowsiness Test (KDT) three times during scheduled wakefulness. During the KDT, participants fixate on a point on the wall from a one-meter distance for five minutes (eyes open). These sessions will provide EEG data with relatively few artefacts. As the first indicator for objective sleepiness, EEG-derived alpha/theta ratio will be calculated.
Measured: Through study completion, estimated 1.5 years (within 3 weeks for each participant)
Objective sleepiness 2
The volunteers will perform a Karolinska Drowsiness Test (KDT) three times during scheduled wakefulness. During the KDT, participants fixate on a point on the wall from a one-meter distance for five minutes (eyes open). These sessions will provide EEG data with relatively few artefacts. As the second indicator for objective sleepiness, electro-oculogram-derived (EOG-derived) slow-eye movements will be calculated.
Measured: Through study completion, estimated 1.5 years (within 3 weeks for each participant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start22 Sep 2022
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Psychiatric Clinics Basel
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Dr Christian Cajochen, University Psychiatric Clinics Basel
- Investigators
- Christian Cajochen, PhD, Principal investigator, Centre for Chronobiology, University Psychiatric Clinics Basel, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483296
- Sponsor's protocol ID
- 2022-00432
- Acronym
- TeenLight
- Status last verified
- Mar 2025
- First submitted
- 25 Jul 2022
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified, anonymised, non-sensitive data will be made available in a publicly accessible repository hosted on https://figshare.com/ after data collection, curation, and publication. The data will be licensed under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). This allows for sharing (copying and redistributing the material in any medium or format) and adapting (remixing, transforming, and building upon the material) under the following terms: Users must give appropriate credit, provide a link to the license, and indicate if changes were made. Users may not use the material for commercial purposes. Parts of the anonymised data can become available even before due to journal publications. Therefore, apart from our research team, the dataset might benefit other research groups working on similar questions in the non-visual processing of light.
Publications
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.
PubMed 29590464Hagenauer 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.
PubMed 19546564Lo 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.
PubMed 29648616Santhi 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.
PubMed 32771123Akerstedt 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.
PubMed 2265922Gabel 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.
PubMed 31069648Spitschan 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.
PubMed 30538662Parrott AC, Hindmarch I. The Leeds Sleep Evaluation Questionnaire in psychopharmacological investigations - a review. Psychopharmacology (Berl). 1980;71(2):173-9. doi: 10.1007/BF00434408.
PubMed 6777817Chellappa 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.
PubMed 19750925
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulating Evening Responses to Light by Afternoon Light Exposure in Adolescents
- ClinicalTrials.gov ID
- NCT05483296
- Acronym / sponsor ID
- TeenLight / 2022-00432
- Conditions
- Healthy, Teenager, Healthy Lifestyle
- Keywords
- melatonin, polysomnography, EEG, sleep, afternoon light, pupil size, evening light
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Psychiatric Clinics BaselResearch network
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Crossover sequence 1: Dim, Moderate, Bright | Experimental | Other: Dim light condition, Other: Moderate light condition, Other: Bright light conditionAll 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. |
| Crossover sequence 2: Dim, Bright, Moderate | Experimental | Other: Dim light condition, Other: Moderate light condition, Other: Bright light conditionAll 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. |
| Crossover sequence 3: Moderate, Dim, Bright | Experimental | –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. |
| Crossover sequence 4: Moderate, Bright, Dim | Experimental | –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. |
| Crossover sequence 5: Bright, Moderate, Dim | Experimental | –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. |
| Crossover sequence 6: Bright, Dim, Moderate | Experimental | –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. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dim light conditionDuring 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. | Other | Crossover sequence 1: Dim, Moderate, Bright, Crossover sequence 2: Dim, Bright, Moderate |
| Moderate light conditionDuring 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. | Other | Crossover sequence 1: Dim, Moderate, Bright, Crossover sequence 2: Dim, Bright, Moderate |
| Bright light conditionDuring 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. | Other | Crossover sequence 1: Dim, Moderate, Bright, Crossover sequence 2: Dim, Bright, Moderate |
Primary outcome
Salivary melatonin
Time frame: Through study completion, estimated 1.5 years (within 3 weeks for each participant)
Salivary melatonin. Saliva samples (>1 mL) will be taken from the participants every 30 Minutes using Salivettes. The Salivettes will be centrifuged, the cotton part removed and immediately frozen at -20°C. At a later point, melatonin [in pg] will be determined in these samples by double-antibody radioimmunoassay (RIA). To quantify melatonin suppression, the analytic team will calculate the area under the curve (AUC) for each laboratory condition.
9 secondary outcomes
Sleep Onset Latency (PSG-derived)
Time frame: Through study completion, estimated 1.5 years (within 3 weeks for each participant)
Slow wave activity (PSG-derived)
Time frame: Through study completion, estimated 1.5 years (within 3 weeks for each participant)
Sleep stages (PSG-derived)
Time frame: Through study completion, estimated 1.5 years (within 3 weeks for each participant)
Subjective sleepiness
Time frame: Through study completion, estimated 1.5 years (within 3 weeks for each participant)
Vigilant attention
Time frame: Through study completion, estimated 1.5 years (within 3 weeks for each participant)
Melanopsin sensitivity (pupillary light response)
Time frame: Through study completion, estimated 1.5 years (within 3 weeks for each participant)
Skin temperature
Time frame: Through study completion, estimated 1.5 years (within 3 weeks for each participant)
Objective sleepiness 1
Time frame: Through study completion, estimated 1.5 years (within 3 weeks for each participant)
Objective sleepiness 2
Time frame: Through study completion, estimated 1.5 years (within 3 weeks for each participant)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Background: PubMed 29590464Galland 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.
- Background: PubMed 19546564Hagenauer 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.
- Background: PubMed 29648616Lo 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.
- Background: PubMed 32771123Santhi 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.
- Background: PubMed 2265922Akerstedt 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.
- Background: PubMed 31069648Gabel 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.
- Background: PubMed 30538662Spitschan 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.
- Background: PubMed 6777817Parrott AC, Hindmarch I. The Leeds Sleep Evaluation Questionnaire in psychopharmacological investigations - a review. Psychopharmacology (Berl). 1980;71(2):173-9. doi: 10.1007/BF00434408.
- Background: PubMed 19750925Chellappa 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.
- Individual participant dataSharing planned: Yes. Deidentified, anonymised, non-sensitive data will be made available in a publicly accessible repository hosted on https://figshare.com/ after data collection, curation, and publication. The data will be licensed under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). This allows for sharing (copying and redistributing the material in any medium or format) and adapting (remixing, transforming, and building upon the material) under the following terms: Users must give appropriate credit, provide a link to the license, and indicate if changes were made. Users may not use the material for commercial purposes. Parts of the anonymised data can become available even before due to journal publications. Therefore, apart from our research team, the dataset might benefit other research groups working on similar questions in the non-visual processing of light.
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Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Cajochen, PhD principal investigator
Centre for Chronobiology, University Psychiatric Clinics Basel, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dim light condition, Moderate light condition and Bright light condition in people with Healthy and Teenager, run by University Psychiatric Clinics Basel at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary melatonin (time frame: Through study completion, estimated 1.5 years (within 3 weeks for each participant)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05483296, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.