AgedLIFENCT05107947
Light in Frail Elderly - the Effect of a Dynamic Light for Sleep and Circadian Rhythm
A study testing Biocentric light in people with Aged and Circadian Rhythm, run by Region Skane at 1 site in Sweden.
Trial summary
The aim of this project is to evaluate the effect of a dynamic light in order to improve the circadian rhythm, provide a better sleep and well-being, and in the long run an improved recovery. The primary question is whether dynamic artificial light with circadian stimulus can affect the circadian rhythm. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aged, Circadian Rhythm, Cognition
- What is being tested?
- Biocentric light
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSweden
- Study dates
- 31 Oct 2022to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Over the age of 65 years
- Admitted to one of the included study rooms
Who cannot join
- Overdose addictive substance
- Acute neurological disease
- Melatonin treatment
- Probable survival <5 days
- Severe visual impairment that makes reading impossible
- Age <65 years
Show all 12Show fewer
- Inability to understand Swedish in speech and writing
- Inability to consent to participate in the study
- The patient is on any of the following medicines:
- Medications for Parkinson's disease
- Neuroleptics (including lithium)
- Dementia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Skåne University Hospital Malmö
Malmö, 21428
Klas Sjöberg, Prof, MD, +46 040 33 61 61, klas.sjoberg@med.lu.se
Rose-Marie K Andersson, Nurse, +46 0765 642015, rose-marie.andersson@med.lu.se
About this study
The aim of this project is to evaluate the effect of a dynamic light in order to improve the circadian rhythm, provide a better sleep and well-being, and in the long run an improved recovery. The primary question is whether dynamic artificial light with circadian stimulus can affect the circadian rhythm. The secondary question is whether this also provides better sleep and well-being.
The group that is particularly interesting to study is a geriatric population that is more sensitive to circadian rhythm disorders, sleep disorders and confusion in connection with hospitalization and that can be of particular benefit from this intervention.
Read the detailed description
This is a randomized, prospective study where the diurnal variation of melatonin as well as sleep-related parameters (sleep duration and sleep quality) will be investigated with regards to light exposure during the hospital stay. Furthermore, it is investigated how psychological and cognitive functions are affected by light intervention and whether this is related to improved sleep or not. The study includes a total of 300 patients over the age of 65 who are cared for in an internal medicine or orthopedic surgery department at Skåne University Hospital in Malmö. The measurement period in the project is intended to be carried out during the period of October 2021-February 2022. Hospital rooms in the orthopedic department and in the medical department constitute the study environment. In all rooms, a biocentric lighting environment will be able to be created by activating a special lighting system. In these rooms, light will change dynamically both in spectral distribution and intensity during the day. During the day, color temperature and intensity are high (1000 lux and up to 6500 K) to decrease both intensity and color temperature during the evening. By weighing together spectral distribution and brightness, the circadian stimulus of the light environment can be calculated. The biocentric light provides a light with a high circadian stimulus during the morning and early afternoon. The biocentric light can be turned on (intervention) or off (control). When control setting, the standard normal light constitutes the light environment.
In all rooms included in the study, an accurate measurement of light conditions is carried out both with regard to spectral distribution and light intensity. Furthermore, patients will carry light meters to measure the actual amount of light to which patients are exposed. The study includes two arms, an intervention group and a control group. Patients who are assigned to one of the study rooms, and meet the inclusion criteria, will be asked to participate in the study. Patients are randomized to activate the biocentric light environment or standard light environment. The patients who are cared for in a biocentric light environment are included in the intervention group and those who are cared for in rooms with a standard light environment are included in the control group.
300 patients are to be included in the study. Surveys concerning alertness, sleep will be carried out. The frailty and a rapid test for delirium will be assessed. The patients will wear an actiwatch that records their sleep. For a small group of patients, also saliva melatonin will be collected every 4th hour from 7 pm to 11 am for two different nights 3 days apart. The results will be compared between the patients in the intervention group and the control group.
- Being tested
- Biocentric light
- Medical subject headings
- Fatigue, Frailty, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biocentric lightOther
Light that changes in intensity and spectral distribution during the day to mimick daylight. High in intensity and high circadian stimulus during daytime and low intensity and low circadian stimulus during late afternoon and night.
| Study group | Role | What they receive |
|---|---|---|
| Intervention biocentric light environment | Experimental | In all study rooms, a biocentric lighting environment will be able to be created by activating a special lighting system. In these rooms, light will change dynamically both in spectral distribution and intensity during the day. During the day, color temperature and intensity are high (1000 lux and up to 6500 K) to decrease both intensity and color temperature during the evening. Receives: Other: Biocentric light |
| Control standard light environment | No intervention | Standard static light environment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melatonin curve
A change in the phase of the melatonin curve
Measured: Change after three days of biocentric light exposure
Secondary outcomes (1)
Sleep
Change in sleep time
Measured: Increased total sleep time after three days of biocentric light exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start31 Oct 2022
- Primary completionMar 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgedStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One intervention group and one control group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Madeleine Selvander, MD, PhD, Principal investigator, Lunds Universitet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107947
- Sponsor's protocol ID
- 2021-02765
- Acronym
- LIFE
- Status last verified
- Jan 2026
- First submitted
- 26 Oct 2021
- Last updated
- 12 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Light in Frail Elderly - the Effect of a Dynamic Light for Sleep and Circadian Rhythm
- ClinicalTrials.gov ID
- NCT05107947
- Acronym / sponsor ID
- LIFE / 2021-02765
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 4 Nov 2021 (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 this project is to evaluate the effect of a dynamic light in order to improve the circadian rhythm, provide a better sleep and well-being, and in the long run an improved recovery. The primary question is whether dynamic artificial light with circadian stimulus can affect the circadian rhythm. The secondary question is whether this also provides better sleep and well-being.
The group that is particularly interesting to study is a geriatric population that is more sensitive to circadian rhythm disorders, sleep disorders and confusion in connection with hospitalization and that can be of particular benefit from this intervention.
Detailed description
This is a randomized, prospective study where the diurnal variation of melatonin as well as sleep-related parameters (sleep duration and sleep quality) will be investigated with regards to light exposure during the hospital stay. Furthermore, it is investigated how psychological and cognitive functions are affected by light intervention and whether this is related to improved sleep or not. The study includes a total of 300 patients over the age of 65 who are cared for in an internal medicine or orthopedic surgery department at Skåne University Hospital in Malmö. The measurement period in the project is intended to be carried out during the period of October 2021-February 2022. Hospital rooms in the orthopedic department and in the medical department constitute the study environment. In all rooms, a biocentric lighting environment will be able to be created by activating a special lighting system. In these rooms, light will change dynamically both in spectral distribution and intensity during the day. During the day, color temperature and intensity are high (1000 lux and up to 6500 K) to decrease both intensity and color temperature during the evening. By weighing together spectral distribution and brightness, the circadian stimulus of the light environment can be calculated. The biocentric light provides a light with a high circadian stimulus during the morning and early afternoon. The biocentric light can be turned on (intervention) or off (control). When control setting, the standard normal light constitutes the light environment.
In all rooms included in the study, an accurate measurement of light conditions is carried out both with regard to spectral distribution and light intensity. Furthermore, patients will carry light meters to measure the actual amount of light to which patients are exposed. The study includes two arms, an intervention group and a control group. Patients who are assigned to one of the study rooms, and meet the inclusion criteria, will be asked to participate in the study. Patients are randomized to activate the biocentric light environment or standard light environment. The patients who are cared for in a biocentric light environment are included in the intervention group and those who are cared for in rooms with a standard light environment are included in the control group.
300 patients are to be included in the study. Surveys concerning alertness, sleep will be carried out. The frailty and a rapid test for delirium will be assessed. The patients will wear an actiwatch that records their sleep. For a small group of patients, also saliva melatonin will be collected every 4th hour from 7 pm to 11 am for two different nights 3 days apart. The results will be compared between the patients in the intervention group and the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One intervention group and one control group
| Arm | Type | Receives |
|---|---|---|
| Intervention biocentric light environment | Experimental | Other: Biocentric lightIn all study rooms, a biocentric lighting environment will be able to be created by activating a special lighting system. In these rooms, light will change dynamically both in spectral distribution and intensity during the day. During the day, color temperature and intensity are high (1000 lux and up to 6500 K) to decrease both intensity and color temperature during the evening. |
| Control standard light environment | No intervention | –Standard static light environment. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Over the age of 65 years
- Admitted to one of the included study rooms
Key exclusion criteria (12 listed)
- Overdose addictive substance
- Acute neurological disease
- Melatonin treatment
- Probable survival <5 days
- Severe visual impairment that makes reading impossible
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 |
|---|---|---|
| Biocentric lightLight that changes in intensity and spectral distribution during the day to mimick daylight. High in intensity and high circadian stimulus during daytime and low intensity and low circadian stimulus during late afternoon and night. | Other | Intervention biocentric light environment |
Primary outcome
Melatonin curve
Time frame: Change after three days of biocentric light exposure
A change in the phase of the melatonin curve
1 secondary outcome
Sleep
Time frame: Increased total sleep time after three days of biocentric light exposure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Madeleine Selvander, MD, PhD principal investigator
Lunds Universitet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biocentric light in people with Aged and Circadian Rhythm, run by Region Skane at 1 site in Sweden.
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 2 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 12 Jan 2026. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madeleine Selvander, MD, PhD (+4640 33 32 27, madeleine.selvander@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Melatonin curve (time frame: Change after three days of biocentric light exposure). 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 12 Jan 2026.