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Completed

NCT Number: NCT06908395

Impact Of Everyday Light Exposure Patterns On Health

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital at RWTH Aachen

Aachen, 52074, Germany

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

10-day ambulatory assessment in everyday life combined with two laboratory office days

Other

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Lense degeneration

    Time frame: Baseline

    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.

  2. Macular and retinal thickness

    Time frame: Baseline

    ophthalmologic evaluation of an Optical Coherence Tomography (OCT) scan

  3. 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

    Interstitial glucose levels measured by continuous glucose monitors

  4. 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

    Manually measured via automated blood pressure cuffs

  5. 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

    Manually measured via automated blood pressure cuffs

  6. Skin temperature

    Time frame: from 09:00 to 17:00 h on day 11 and 12

    in °C assessed via wireless temperature sensors (iButtons) placed on the hand, neck, clavicular and shin

  7. Alertness

    Time frame: at least 6 times daily over all 12 study days

    measured via Karolinska Sleepiness Scale through the m-Path app

  8. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline

    PSQI score calculated based on a digital questionnaire

  9. Munich Chronotype Questionnaire (MCU)

    Time frame: Baseline

    Chronotype score calculated based on a digital questionnaire

  10. Subjective sleep quality

    Time frame: every morning over the 12 study days

    measured via Consensus Sleep Diary through the m-Path app

Other outcomes

  1. Digital food photo diary

    Time frame: continuously throughout the 12-day study period

    Participants take photos of every caffeine- or calorie-containing food item that they consume and upload them in the m-Path app

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Official study title

Impact of Everyday Light Exposure Patterns on Metabolic, Cardiovascular, and Psychological Health in Younger and Older Adults

Acronym: AgeLight

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 3, 2025
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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