Healthy Clinical Trial
— TeenLightOfficial title:
Modulating Evening Responses to Light by Afternoon Light Exposure in Adolescents
Verified date | December 2023 |
Source | University Psychiatric Clinics Basel |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 27 |
Est. completion date | June 20, 2023 |
Est. primary completion date | June 20, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 14 Years to 17 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Psychiatric University Clinics (UPK), Centre for Chronobiology | Basel | Canton Of Basel City |
Lead Sponsor | Collaborator |
---|---|
University Psychiatric Clinics Basel |
Switzerland,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Ambulant light history. | To account for participants' light exposure before they arrive at the experimental site, ambulatory light exposure will be assessed throughout the three weeks of the experiment with actimetry devices (Condor ActTrust). Additionally, participants will be asked to estimate their duration of outdoor light exposure daily. During the experiment, participants will further be instructed to wear a lightweight light sensor. | Through study completion, estimated 1.5 years (within 3 weeks for each participant) | |
Other | Actigraphy | Compliance to regular sleep-wake cycles over three weeks will be monitored with the actimetry device starting five days before the first experimental session (baseline + adaptation night) and ending with the final session. | Through study completion, estimated 1.5 years (within 3 weeks for each participant) | |
Other | Visual comfort & well-being | An adapted German version of the first six items of the Visual Comfort Scale (VCS) will be used to assess the participant's visual comfort under the different lighting conditions. Additionally, participants will rate their momentary affect and well-being in relation to mood, hunger, relaxation, and motivation. Items are rated on a 7-point Likert-type scale (1-7) with higher values corresponding to a higher manifestation of the characteristic (for instance well-being, the brightness of the light etc.) | Through study completion, estimated 1.5 years (within 3 weeks for each participant) | |
Other | Sleep diary | Volunteers will report their sleep and wake episodes using a sleep-wake diary (like a questionnaire). | Through study completion, estimated 1.5 years (within 3 weeks for each participant) | |
Other | Sleep quality | In the mornings after the laboratory sleep, participants will additionally fill in a sleep quality questionnaire (Leeds Sleep Evaluation Questionnaire; LSEQ). The LSEQ is a 10-item, subjective, self-report measure that includes a visual analogue scale, where every item is scored from 0 to 10 where 10 corresponds to a higher manifestation of the characteristic (for instance tiredness). | Through study completion, estimated 1.5 years (within 3 weeks for each participant) | |
Other | Dream recall | In the mornings after the laboratory sleep, participants will additionally fill in a dream recall questionnaire (Sleep Mentation Questionnaire) which addresses numerous characteristics of dream recall, such as the number of dreams, emotionality, vividness, pleasantness, hostility, and colourfulness, on a Likert-point scale (1: greatly, 2: fairly, 3: little, and 4: not at all). Higher values on the scale correspond to a lower frequency of dreams. | Through study completion, estimated 1.5 years (within 3 weeks for each participant) | |
Primary | 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. | Through study completion, estimated 1.5 years (within 3 weeks for each participant) | |
Secondary | 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). | Through study completion, estimated 1.5 years (within 3 weeks for each participant) | |
Secondary | 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. | Through study completion, estimated 1.5 years (within 3 weeks for each participant) | |
Secondary | 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. | Through study completion, estimated 1.5 years (within 3 weeks for each participant) | |
Secondary | 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. |
Through study completion, estimated 1.5 years (within 3 weeks for each participant) | |
Secondary | 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. | Through study completion, estimated 1.5 years (within 3 weeks for each participant) | |
Secondary | 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). | Through study completion, estimated 1.5 years (within 3 weeks for each participant) | |
Secondary | 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. | Through study completion, estimated 1.5 years (within 3 weeks for each participant) | |
Secondary | 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. | Through study completion, estimated 1.5 years (within 3 weeks for each participant) | |
Secondary | 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. | Through study completion, estimated 1.5 years (within 3 weeks for each participant) |
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