Healthy Male and Female SubjectsAgeLightNCT06908395
Impact Of Everyday Light Exposure Patterns On Health
A study testing 10-day ambulatory assessment in everyday life combined with two laboratory office days in people with Healthy Male and Female Subjects and Healthy Elderly, run by RWTH Aachen University at 1 site in Germany.
Trial summary
The aim of the present study is to characterize everyday light conditions of younger and older adults and to consider them in relation to cardiovascular, metabolic and psychological health. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Healthy Male and Female Subjects, Healthy Elderly
- What is being tested?
- 10-day ambulatory assessment in everyday life combined with two laboratory office days
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteGermany
- Study dates
- 18 Nov 2024to 30 Jun 2025
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-35 or 60-80 years old
- Voluntary participation, signed consent form
- Owns an Android or iOS Smartphone compatible with the m-Path App
- Generally healthy (self-reported)
- Non-smoker for at least 12 months (self-reported)
Who cannot join
- Pregnancy (for female participants) (self-reported)
- Night-shift worker
- Eye diseases (e.g. glaucoma, age-related macular degeneration, diabetic retinopathy conditions after retinal detachment / retinal blood vessel occlusions)
- Pseudophakic eyes
- Psychological disorders: insomnia, depression, bipolar disorder and generalized anxiety disorder
- Wearing specially-filtered glasses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Everyday Light Exposure Patterns on Metabolic, Cardiovascular, and Psychological Health in Younger and Older Adults
The aim of the present study is to characterize everyday light conditions of younger and older adults and to consider them in relation to cardiovascular, metabolic and psychological health. An ambulatory assessment approach will be used over 12 days, measuring physiological parameters and daily thoughts, behaviors and experiences of different age groups using wearable technologies (e.g., light sensors, activity trackers, continuous glucose monitors) and smartphone-based self-reports (e.g., mood, vitality).
At the beginning of the study, the degeneration of the lens and retina of the participants is objectively quantified by ophthalmologists. On the last two days, participants will spend one working day in dim light and another in bright light in randomized order under the same measurement protocol as before in order to experimentally assess their sensitivity to light and its health effects.
Read the detailed description
This study is designed as an observatory field study of characterizing younger and older adults' everyday life in terms of light exposure patterns as well as cardiovascular, metabolic and psychological health parameters over 10 days continuously through wearables and smartphone-based self-reports (ambulatory assessment period). On the first day of data collection, each participant will undergo an extensive eye examination at the Institute of Ophthalmology, particularly an Optical Coherence Tomography (OCT) scan will conducted and by means of a macular pigment reflectometer the difference between the light entering and leaving the eye across the visual spectrum will be determined as a marker of lense yellowing. Thereafter, participants start wearing the wearable sensors (continuous glucose monitors, light loggers worn as a necklace) and instructions on how to complete the smartphone-based self-report forms are provided. Participants are asked to take pictures of every food or drink (except of water) and upload these pictures through the m-Path app, these photos will be later linked to the continuous glucose monitor data. Data will be collected from the first evening onwards (ca. 18:00 h). After the ambulatory assessment period under free-living conditions, participants will spend the 11th and 12th day in a controlled office room environment from 08:30 to 17:00 h. In a randomized cross-over design, the 11th and 12th day will be spent in either bright (1250 lux) or dim office lighting (10 lux). On these days, participants will continue to wear the wearables and complete the expanded smartphone-based self-reports mostly similar to the 10-day ambulatory assessment period. Between day 11 and 12, participants will leave controlled conditions from 17:00 h on day 11 to 08:30 h on day 12. On day 11 and 12, participants will receive a standardized fluid meals for breakfast and lunch, and are otherwise instructed to avoid any food, caloric or caffeinated beverages between 08:30 and 17:00 h. On these two days, skin temperature sensors will be placed on four different skin regions, and blood pressure will be manually measured at regular intervals between 08:30 h and 17:00 h. After removing all wearables on day 12, the study ends at 17:30 h. Over these 12 days of data collection, participants will be asked to keep their bedtimes at home as consistent as possible between days, and on day 11 and 12 they will be instructed to come to the office facilities fasted without any caloric intake after 22:00 h on the previous evening of day 10 and 11, respectively.
The two comparative groups formed in this study consist of 30 younger adults (18-35 years) and 30 older adults (60-80 years), both females and males will be included, and the aim is to match both groups with respect to sex (i.e. ideally 15 women and 15 men per group). The age contrast in the two groups is chosen, as substantial differences in degeneration of the lenses and retina within the eye can be expected.
For the sample size calculation of n = 30 per group, we refer to Zauner et al. (Zauner et al., 2023), who created a procedure to calculate statistical power and required sample size for wearable light-logging data. For most light-logging metrics, their approach shows that for strong differences in light exposure patterns (i.e., winter vs. summer) even smaller samples are sufficient (n = 3-24). We do not expect that differences between age groups are that strong as seasonal differences. However, we are confident that effects of about d = 0.7 could be detected with our design (n = 30 per group). Considering some drop-out, we anticipate that we will have to enroll 70 participants in total.
With the primary hypothesis of this study being that younger and older individuals differ in their light exposure patterns in everyday life, the two main explorative goals of the AgeLight study are to:
- characterize light exposure patterns in younger and older adults and their link to cardiovascular, metabolic, and psychological health
- identify determining factors of an individual's sensitivity to light and its health effects (such as degeneration of the lens and retina)
- Conditions
- Healthy Male and Female Subjects, Healthy Elderly
- Being tested
- 10-day ambulatory assessment in everyday life combined with two laboratory office days
- Keywords
- Spectral diet, ambulatory assessment, daylight, m-path, eye degeneration, lense yellowing, continuous glucose monitoring, healthy aging, light sensitivity, melanopic EDI
- Medical subject headings
- Photophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10-day ambulatory assessment in everyday life combined with two laboratory office daysOther
Participants undergo a 10-day ambulatory assessment period wearing a continuous glucose monitor and a light logger as a necklace as well as completing short questionnaires through a smartphone app at regular intervals every day. On the first day, participants also undergo an extensive eye examination. Day 11 and 12 are spent in either dim or bright office lighting in randomized order.
| Study group | Role | What they receive |
|---|---|---|
| 10 days ambulatory assessment + 1 office day in bright light + 1 office day in dim light | Experimental | Day 11 is spent under laboratory conditions in bright (1250 lux) office lighting from 08:30 to 17:00 h. Day 12 is spent under laboratory conditions in dim (10 lux) office lighting from 08:30 to 17:00 h. Receives: Other: 10-day ambulatory assessment in everyday life combined with two laboratory office days |
| 10 days ambulatory assessment + 1 office day in dim light + 1 office day in bright light | Experimental | Day 11 is spent under laboratory conditions in dim (10 lux) office lighting from 08:30 to 17:00 h. Day 12 is spent under laboratory conditions in bright (1250 lux) office lighting from 08:30 to 17:00 h. Receives: Other: 10-day ambulatory assessment in everyday life combined with two laboratory office days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean melanopic EDI (lux) from 09:00 to 17:00 h (daytime in European winter months)
Measured via light loggers (ActLumus) worn as a necklace
Measured: Over the 10-day ambulatory assessment period
Mean melanopic EDI (lux) 2 hours before individual bedtime
Measured via light loggers (ActLumus) worn as a necklace
Measured: Over the 10-day ambulatory assessment period
Secondary outcomes (10)
Lense degeneration
The macular pigment reflectometer will record the difference between the light entering and leaving the eye across the visual spectrum. Spectral analysis of the reflected light provides an adequate estimate of the yellowing of the intra-ocular lens.
Measured: Baseline
Macular and retinal thickness
ophthalmologic evaluation of an Optical Coherence Tomography (OCT) scan
Measured: Baseline
Interstitial glucose levels
Interstitial glucose levels measured by continuous glucose monitors
Measured: Over the 10-day ambulatory assessment period, and specifically levels of day 11 and day 12 between 8:30 and 17:00 h upon controlled office lighting
Systolic and diastolic blood pressure
Manually measured via automated blood pressure cuffs
Measured: 09:00, 10:30, 12:00, 13:00, 14:30, 16:00 and 17:00 on day 11 and 12
Heart rate
Manually measured via automated blood pressure cuffs
Measured: 09:00, 10:30, 12:00, 13:00, 14:30, 16:00 and 17:00 h on day 11 and 12
Skin temperature
in °C assessed via wireless temperature sensors (iButtons) placed on the hand, neck, clavicular and shin
Measured: from 09:00 to 17:00 h on day 11 and 12
Alertness
measured via Karolinska Sleepiness Scale through the m-Path app
Measured: at least 6 times daily over all 12 study days
Pittsburgh Sleep Quality Index (PSQI)
PSQI score calculated based on a digital questionnaire
Measured: Baseline
Munich Chronotype Questionnaire (MCU)
Chronotype score calculated based on a digital questionnaire
Measured: Baseline
Subjective sleep quality
measured via Consensus Sleep Diary through the m-Path app
Measured: every morning over the 12 study days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start18 Nov 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male and Female SubjectsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is designed as an observatory field study of characterizing younger and older adults' everyday life over 10 days continuously through wearables and smartphone-based self-reports. In a randomized cross-over design, the 11th and 12th day will be spent in either bright (1250 lux) or dim office lighting (10 lux).
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan-Frieder Harmsen, RWTH Aachen University
- Investigators
- Jan-Frieder Harmsen, PhD, Principal investigator, RWTH Aachen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908395
- Sponsor's protocol ID
- EK 24-324
- Acronym
- AgeLight
- Status last verified
- Jul 2025
- First submitted
- 20 Mar 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol can be requested via email to study officials.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Everyday Light Exposure Patterns on Metabolic, Cardiovascular, and Psychological Health in Younger and Older Adults
- ClinicalTrials.gov ID
- NCT06908395
- Acronym / sponsor ID
- AgeLight / EK 24-324
- Conditions
- Healthy Male and Female Subjects, Healthy Elderly
- Keywords
- Spectral diet, ambulatory assessment, daylight, m-path, eye degeneration, lense yellowing, continuous glucose monitoring, healthy aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 3 Apr 2025 (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.
The aim of the present study is to characterize everyday light conditions of younger and older adults and to consider them in relation to cardiovascular, metabolic and psychological health. An ambulatory assessment approach will be used over 12 days, measuring physiological parameters and daily thoughts, behaviors and experiences of different age groups using wearable technologies (e.g., light sensors, activity trackers, continuous glucose monitors) and smartphone-based self-reports (e.g., mood, vitality).
At the beginning of the study, the degeneration of the lens and retina of the participants is objectively quantified by ophthalmologists. On the last two days, participants will spend one working day in dim light and another in bright light in randomized order under the same measurement protocol as before in order to experimentally assess their sensitivity to light and its health effects.
Detailed description
This study is designed as an observatory field study of characterizing younger and older adults' everyday life in terms of light exposure patterns as well as cardiovascular, metabolic and psychological health parameters over 10 days continuously through wearables and smartphone-based self-reports (ambulatory assessment period). On the first day of data collection, each participant will undergo an extensive eye examination at the Institute of Ophthalmology, particularly an Optical Coherence Tomography (OCT) scan will conducted and by means of a macular pigment reflectometer the difference between the light entering and leaving the eye across the visual spectrum will be determined as a marker of lense yellowing. Thereafter, participants start wearing the wearable sensors (continuous glucose monitors, light loggers worn as a necklace) and instructions on how to complete the smartphone-based self-report forms are provided. Participants are asked to take pictures of every food or drink (except of water) and upload these pictures through the m-Path app, these photos will be later linked to the continuous glucose monitor data. Data will be collected from the first evening onwards (ca. 18:00 h). After the ambulatory assessment period under free-living conditions, participants will spend the 11th and 12th day in a controlled office room environment from 08:30 to 17:00 h. In a randomized cross-over design, the 11th and 12th day will be spent in either bright (1250 lux) or dim office lighting (10 lux). On these days, participants will continue to wear the wearables and complete the expanded smartphone-based self-reports mostly similar to the 10-day ambulatory assessment period. Between day 11 and 12, participants will leave controlled conditions from 17:00 h on day 11 to 08:30 h on day 12. On day 11 and 12, participants will receive a standardized fluid meals for breakfast and lunch, and are otherwise instructed to avoid any food, caloric or caffeinated beverages between 08:30 and 17:00 h. On these two days, skin temperature sensors will be placed on four different skin regions, and blood pressure will be manually measured at regular intervals between 08:30 h and 17:00 h. After removing all wearables on day 12, the study ends at 17:30 h. Over these 12 days of data collection, participants will be asked to keep their bedtimes at home as consistent as possible between days, and on day 11 and 12 they will be instructed to come to the office facilities fasted without any caloric intake after 22:00 h on the previous evening of day 10 and 11, respectively.
The two comparative groups formed in this study consist of 30 younger adults (18-35 years) and 30 older adults (60-80 years), both females and males will be included, and the aim is to match both groups with respect to sex (i.e. ideally 15 women and 15 men per group). The age contrast in the two groups is chosen, as substantial differences in degeneration of the lenses and retina within the eye can be expected.
For the sample size calculation of n = 30 per group, we refer to Zauner et al. (Zauner et al., 2023), who created a procedure to calculate statistical power and required sample size for wearable light-logging data. For most light-logging metrics, their approach shows that for strong differences in light exposure patterns (i.e., winter vs. summer) even smaller samples are sufficient (n = 3-24). We do not expect that differences between age groups are that strong as seasonal differences. However, we are confident that effects of about d = 0.7 could be detected with our design (n = 30 per group). Considering some drop-out, we anticipate that we will have to enroll 70 participants in total.
With the primary hypothesis of this study being that younger and older individuals differ in their light exposure patterns in everyday life, the two main explorative goals of the AgeLight study are to:
- characterize light exposure patterns in younger and older adults and their link to cardiovascular, metabolic, and psychological health
- identify determining factors of an individual's sensitivity to light and its health effects (such as degeneration of the lens and retina)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is designed as an observatory field study of characterizing younger and older adults' everyday life over 10 days continuously through wearables and smartphone-based self-reports. In a randomized cross-over design, the 11th and 12th day will be spent in either bright (1250 lux) or dim office lighting (10 lux).
| Arm | Type | Receives |
|---|---|---|
| 10 days ambulatory assessment + 1 office day in bright light + 1 office day in dim light | Experimental | Other: 10-day ambulatory assessment in everyday life combined with two laboratory office daysDay 11 is spent under laboratory conditions in bright (1250 lux) office lighting from 08:30 to 17:00 h. Day 12 is spent under laboratory conditions in dim (10 lux) office lighting from 08:30 to 17:00 h. |
| 10 days ambulatory assessment + 1 office day in dim light + 1 office day in bright light | Experimental | Other: 10-day ambulatory assessment in everyday life combined with two laboratory office daysDay 11 is spent under laboratory conditions in dim (10 lux) office lighting from 08:30 to 17:00 h. Day 12 is spent under laboratory conditions in bright (1250 lux) office lighting from 08:30 to 17:00 h. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18-35 or 60-80 years old
- Voluntary participation, signed consent form
- Owns an Android or iOS Smartphone compatible with the m-Path App
- Generally healthy (self-reported)
- Non-smoker for at least 12 months (self-reported)
Key exclusion criteria (6 listed)
- Pregnancy (for female participants) (self-reported)
- Night-shift worker
- Eye diseases (e.g. glaucoma, age-related macular degeneration, diabetic retinopathy conditions after retinal detachment / retinal blood vessel occlusions)
- Pseudophakic eyes
- Psychological disorders: insomnia, depression, bipolar disorder and generalized anxiety disorder
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 |
|---|---|---|
| 10-day ambulatory assessment in everyday life combined with two laboratory office daysParticipants undergo a 10-day ambulatory assessment period wearing a continuous glucose monitor and a light logger as a necklace as well as completing short questionnaires through a smartphone app at regular intervals every day. On the first day, participants also undergo an extensive eye examination. Day 11 and 12 are spent in either dim or bright office lighting in randomized order. | Other | 10 days ambulatory assessment + 1 office day in bright light + 1 office day in dim light, 10 days ambulatory assessment + 1 office day in dim light + 1 office day in bright light |
Primary outcome
Mean melanopic EDI (lux) from 09:00 to 17:00 h (daytime in European winter months)
Time frame: Over the 10-day ambulatory assessment period
Measured via light loggers (ActLumus) worn as a necklace
Mean melanopic EDI (lux) 2 hours before individual bedtime
Time frame: Over the 10-day ambulatory assessment period
Measured via light loggers (ActLumus) worn as a necklace
10 secondary outcomes
Lense degeneration
Time frame: Baseline
Macular and retinal thickness
Time frame: Baseline
Interstitial glucose levels
Time frame: Over the 10-day ambulatory assessment period, and specifically levels of day 11 and day 12 between 8:30 and 17:00 h upon controlled office lighting
Systolic and diastolic blood pressure
Time frame: 09:00, 10:30, 12:00, 13:00, 14:30, 16:00 and 17:00 on day 11 and 12
Heart rate
Time frame: 09:00, 10:30, 12:00, 13:00, 14:30, 16:00 and 17:00 h on day 11 and 12
Skin temperature
Time frame: from 09:00 to 17:00 h on day 11 and 12
Alertness
Time frame: at least 6 times daily over all 12 study days
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline
Munich Chronotype Questionnaire (MCU)
Time frame: Baseline
Subjective sleep quality
Time frame: every morning over the 12 study days
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 10 Jul 2025.
- Individual participant dataSharing planned: Yes. The study protocol can be requested via email to study officials.
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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.
Jan-Frieder Harmsen, PhD principal investigator
RWTH Aachen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10-day ambulatory assessment in everyday life combined with two laboratory office days in people with Healthy Male and Female Subjects and Healthy Elderly, run by RWTH Aachen University at 1 site in Germany.
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 6 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 10 Jul 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 Germany. 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?
Mean melanopic EDI (lux) from 09:00 to 17:00 h (daytime in European winter months) (time frame: Over the 10-day ambulatory assessment period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2025.