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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Germany1 site
  • University hospital at RWTH Aachen

    Aachen, 52074

Other trials in Germany

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)
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 groups in NCT06908395
Study groupRoleWhat they receive
10 days ambulatory assessment + 1 office day in bright light + 1 office day in dim lightExperimentalDay 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 lightExperimentalDay 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.

  1. 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

  2. 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)
  1. 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

  2. Macular and retinal thickness

    ophthalmologic evaluation of an Optical Coherence Tomography (OCT) scan

    Measured: Baseline

  3. 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

  4. 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

  5. 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

  6. 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

  7. Alertness

    measured via Karolinska Sleepiness Scale through the m-Path app

    Measured: at least 6 times daily over all 12 study days

  8. Pittsburgh Sleep Quality Index (PSQI)

    PSQI score calculated based on a digital questionnaire

    Measured: Baseline

  9. Munich Chronotype Questionnaire (MCU)

    Chronotype score calculated based on a digital questionnaire

    Measured: Baseline

  10. 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.

  1. First posted3 Apr 2025
  2. Study start18 Nov 2024
  3. Primary completion30 Jun 2025
  4. Study completion30 Jun 2025

Resources

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)
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.

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.

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