DementiaNCT05535790
Effect of Circadian Light on Hospitalized Persons With Dementia and Older Adults With Cognitive Impairments.
A study testing Naturalistic LED light and Standard/traditional lighting in people with Dementia and Cognitive Impairment, run by Zealand University Hospital.
Trial summary
Light stimulates the human visual system and the biological functions in the retina, also referred to as non-visual responses, e.g. hormone production. Exposure to the correct light composition can produce acute alertness and increase good sleep quality (1). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Cognitive Impairment
- What is being tested?
- Naturalistic LED light and Standard/traditional lighting
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 1 May 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients with a recognized dementia diagnosis by the time of admission
- Patients who, during admission, are found to have cognitive impairments
- Patients who, during admission, are found to have delirium
Who cannot join
- Patients with psychiatric conditions which in and of themselves might account for the patients' cognitive impairment will be excluded
- Inability to speak (aphasia)
- Patients with a linguistic or cultural background other than Danish
- Patients with ongoing abuse of alcohol, narcotics or sedative pharmaceutics
- Patients with impaired level of consciousness due to other causes than delirium.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: PAX: A Randomized Single-blind Controlled Trial of the Effect of Circadian Light on Hospitalized Persons With Dementia and Older Adults With Cognitive Impairments
Light stimulates the human visual system and the biological functions in the retina, also referred to as non-visual responses, e.g. hormone production. Exposure to the correct light composition can produce acute alertness and increase good sleep quality (1).
In this study, subjects will be exposed to 24-hour LED naturalistic lighting (intervention) or traditional lighting (control) during all days of hospitalization. Subjects will be blinded to the intervention as they will not be told if they are admitted to an intervention patient room or a control patient room.
Read more
The primary outcome measure is cortisol levels measured in saliva samples. Secondary outcome measures are delirium rates, length of admission, use of constant observation, mortality and adverse advent.
It is estimated that 80 subjects will be included in the study.
Read the detailed description
During hospitalization, patient rooms are often associated with poor lighting conditions, and patients are often not exposed to outdoor activities. Many patients have difficulties sleeping during hospital admission, which affects health outcomes and potentially leads to prolonged admission and rehabilitation and a higher risk of developing delirium. However, the circadian rhythm can be modified with LED light, as this technology can reach sufficient levels to affect the human melanopic equivalent daylight illuminance (Melanopic EDI). A high melanopic EDI during the day is supportive for alertness and a good night's sleep. A good night's sleep is essential to prevent the development of delirium. LED lighting, which can give melanopic EDI, is called naturalistic light (1,2).
In this study, subjects will be exposed to 24-hour LED naturalistic lighting (intervention) or traditional lighting of fluorescent tubes (control) during all days of hospitalization. Subjects will be blinded to the intervention as they will not be told if they are admitted to an intervention patient room or a control patient room. The study includes subjects who are diagnosed with dementia (mild-moderate) or older adults (+65 years) who have cognitive impairments. Subjects will be screened before inclusion using a mini-mental state examination (MMSE) (3) and clinical examination by trained specialists.
To test the effect of exposure to circadian light, the study is designed as a single-centre exploratory parallel-arm randomized controlled trial. The trial will be thoroughly reported according to the CONSORT (4) statement extended guidelines
The primary outcome measure is cortisol levels measured in saliva samples. The samples are collected two times each day during hospitalization. One sample is collected at <30 minutes after the subject has woken in the morning (during the morning cortisol peak) and one sample in the evening when the highest level is expected.
Secondary outcome measures are delirium rates, length of admission, need for escape prevention, mortality, use of antipsychotics and adverse advent e.g. patient related fall incidents. Delirium rates are collected by performing a confusion assessment method (CAM) (5) score two times a day. Additional measurements are collected in patient charts.
To reach sufficient power, we estimate that 80 subjects will be included in the study. 40 subjects are admitted to the intervention room (with naturalistic lighting), and 40 are admitted to the control room (traditional/standard lighting conditions).
- Conditions
- Dementia, Cognitive Impairment
- Being tested
- Naturalistic LED light, Standard/traditional lighting
- Medical subject headings
- Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naturalistic LED lightOther
Naturalistic LED light (bright light therapy) which affects Melanopic Equivalent Daylight Illuminance.
Standard/traditional lightingOther
Standard/tradtional lighting environment with fluorescent tubes
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Exposure to 24-hour LED naturalistic lighting Receives: Other: Naturalistic LED light |
| Control group | Sham comparator | Exposure to standard/traditional lighting setting with fluorescent tubes Receives: Other: Standard/traditional lighting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortisol
Cortisol levels measured in saliva samples
Measured: During intervention period
Secondary outcomes (6)
Delirium
Delirium measured in CAM score
Measured: During intervention period
Length of admission
Length of admission collected from patient charts
Measured: During intervention period
Pharmaceutics
Use of pharmaceutics during hospitalization. Collected from patient charts.
Measured: During intervention period
Mortality
Mortality rates collected from patient charts
Measured: During intervention period
Adverse advent
Adverse advent, e.g. patient related fall incidents, collected from patient charts
Measured: During intervention period
Constant observation
Need of constant observation from health professionals, collected from patient charts
Measured: During intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Denmark, University of Copenhagen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535790
- Sponsor's protocol ID
- SJ-899
- Status last verified
- Aug 2022
- First submitted
- 6 Sep 2022
- Last updated
- 10 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Figueiro MG, Nagare R, Price L. Non-visual effects of light: how to use light to promote circadian entrainment and elicit alertness. Light Res Technol. 2018;50(1):38-62. doi: 10.1177/1477153517721598. Epub 2017 Jul 25.
PubMed 30416392Figueiro MG. Light, sleep and circadian rhythms in older adults with Alzheimer's disease and related dementias. Neurodegener Dis Manag. 2017 Apr;7(2):119-145. doi: 10.2217/nmt-2016-0060. Epub 2017 May 23.
PubMed 28534696Creavin ST, Wisniewski S, Noel-Storr AH, Trevelyan CM, Hampton T, Rayment D, Thom VM, Nash KJ, Elhamoui H, Milligan R, Patel AS, Tsivos DV, Wing T, Phillips E, Kellman SM, Shackleton HL, Singleton GF, Neale BE, Watton ME, Cullum S. Mini-Mental State Examination (MMSE) for the detection of dementia in clinically unevaluated people aged 65 and over in community and primary care populations. Cochrane Database Syst Rev. 2016 Jan 13;2016(1):CD011145. doi: 10.1002/14651858.CD011145.pub2.
PubMed 26760674Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010 Mar 24;8:18. doi: 10.1186/1741-7015-8-18.
PubMed 20334633Wei LA, Fearing MA, Sternberg EJ, Inouye SK. The Confusion Assessment Method: a systematic review of current usage. J Am Geriatr Soc. 2008 May;56(5):823-30. doi: 10.1111/j.1532-5415.2008.01674.x. Epub 2008 Apr 1.
PubMed 18384586
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PAX: A Randomized Single-blind Controlled Trial of the Effect of Circadian Light on Hospitalized Persons With Dementia and Older Adults With Cognitive Impairments
- ClinicalTrials.gov ID
- NCT05535790
- Acronym / sponsor ID
- SJ-899
- Conditions
- Dementia, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- Technical University of Denmark, University of Copenhagen
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 10 Sep 2022 (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.
Light stimulates the human visual system and the biological functions in the retina, also referred to as non-visual responses, e.g. hormone production. Exposure to the correct light composition can produce acute alertness and increase good sleep quality (1).
In this study, subjects will be exposed to 24-hour LED naturalistic lighting (intervention) or traditional lighting (control) during all days of hospitalization. Subjects will be blinded to the intervention as they will not be told if they are admitted to an intervention patient room or a control patient room.
The primary outcome measure is cortisol levels measured in saliva samples. Secondary outcome measures are delirium rates, length of admission, use of constant observation, mortality and adverse advent.
It is estimated that 80 subjects will be included in the study.
Detailed description
During hospitalization, patient rooms are often associated with poor lighting conditions, and patients are often not exposed to outdoor activities. Many patients have difficulties sleeping during hospital admission, which affects health outcomes and potentially leads to prolonged admission and rehabilitation and a higher risk of developing delirium. However, the circadian rhythm can be modified with LED light, as this technology can reach sufficient levels to affect the human melanopic equivalent daylight illuminance (Melanopic EDI). A high melanopic EDI during the day is supportive for alertness and a good night's sleep. A good night's sleep is essential to prevent the development of delirium. LED lighting, which can give melanopic EDI, is called naturalistic light (1,2).
In this study, subjects will be exposed to 24-hour LED naturalistic lighting (intervention) or traditional lighting of fluorescent tubes (control) during all days of hospitalization. Subjects will be blinded to the intervention as they will not be told if they are admitted to an intervention patient room or a control patient room. The study includes subjects who are diagnosed with dementia (mild-moderate) or older adults (+65 years) who have cognitive impairments. Subjects will be screened before inclusion using a mini-mental state examination (MMSE) (3) and clinical examination by trained specialists.
To test the effect of exposure to circadian light, the study is designed as a single-centre exploratory parallel-arm randomized controlled trial. The trial will be thoroughly reported according to the CONSORT (4) statement extended guidelines
The primary outcome measure is cortisol levels measured in saliva samples. The samples are collected two times each day during hospitalization. One sample is collected at <30 minutes after the subject has woken in the morning (during the morning cortisol peak) and one sample in the evening when the highest level is expected.
Secondary outcome measures are delirium rates, length of admission, need for escape prevention, mortality, use of antipsychotics and adverse advent e.g. patient related fall incidents. Delirium rates are collected by performing a confusion assessment method (CAM) (5) score two times a day. Additional measurements are collected in patient charts.
To reach sufficient power, we estimate that 80 subjects will be included in the study. 40 subjects are admitted to the intervention room (with naturalistic lighting), and 40 are admitted to the control room (traditional/standard lighting conditions).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Naturalistic LED lightExposure to 24-hour LED naturalistic lighting |
| Control group | Sham comparator | Other: Standard/traditional lightingExposure to standard/traditional lighting setting with fluorescent tubes |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients with a recognized dementia diagnosis by the time of admission
- Patients who, during admission, are found to have cognitive impairments
- Patients who, during admission, are found to have delirium
Key exclusion criteria (5 listed)
- Patients with psychiatric conditions which in and of themselves might account for the patients' cognitive impairment will be excluded
- Inability to speak (aphasia)
- Patients with a linguistic or cultural background other than Danish
- Patients with ongoing abuse of alcohol, narcotics or sedative pharmaceutics
- Patients with impaired level of consciousness due to other causes than delirium.
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 |
|---|---|---|
| Naturalistic LED lightNaturalistic LED light (bright light therapy) which affects Melanopic Equivalent Daylight Illuminance. | Other | Intervention group |
| Standard/traditional lightingStandard/tradtional lighting environment with fluorescent tubes | Other | Control group |
Primary outcome
Cortisol
Time frame: During intervention period
Cortisol levels measured in saliva samples
6 secondary outcomes
Delirium
Time frame: During intervention period
Length of admission
Time frame: During intervention period
Pharmaceutics
Time frame: During intervention period
Mortality
Time frame: During intervention period
Adverse advent
Time frame: During intervention period
Constant observation
Time frame: During intervention period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
- Background: PubMed 30416392Figueiro MG, Nagare R, Price L. Non-visual effects of light: how to use light to promote circadian entrainment and elicit alertness. Light Res Technol. 2018;50(1):38-62. doi: 10.1177/1477153517721598. Epub 2017 Jul 25.
- Background: PubMed 28534696Figueiro MG. Light, sleep and circadian rhythms in older adults with Alzheimer's disease and related dementias. Neurodegener Dis Manag. 2017 Apr;7(2):119-145. doi: 10.2217/nmt-2016-0060. Epub 2017 May 23.
- Background: PubMed 26760674Creavin ST, Wisniewski S, Noel-Storr AH, Trevelyan CM, Hampton T, Rayment D, Thom VM, Nash KJ, Elhamoui H, Milligan R, Patel AS, Tsivos DV, Wing T, Phillips E, Kellman SM, Shackleton HL, Singleton GF, Neale BE, Watton ME, Cullum S. Mini-Mental State Examination (MMSE) for the detection of dementia in clinically unevaluated people aged 65 and over in community and primary care populations. Cochrane Database Syst Rev. 2016 Jan 13;2016(1):CD011145. doi: 10.1002/14651858.CD011145.pub2.
- Background: PubMed 20334633Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010 Mar 24;8:18. doi: 10.1186/1741-7015-8-18.
- Background: PubMed 18384586Wei LA, Fearing MA, Sternberg EJ, Inouye SK. The Confusion Assessment Method: a systematic review of current usage. J Am Geriatr Soc. 2008 May;56(5):823-30. doi: 10.1111/j.1532-5415.2008.01674.x. Epub 2008 Apr 1.
- 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Naturalistic LED light and Standard/traditional lighting in people with Dementia and Cognitive Impairment, run by Zealand University Hospital.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Ballegaard, MD, PhD ((+45) 47 32 29 09, mbag@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortisol (time frame: During intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05535790, which also lists 5 linked publications.
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 Sep 2022.