Effect of Circadian Light on Hospitalized Persons With Dementia and Older Adults With Cognitive Impairments.

NCT05535790 | Unknown

• 1 other identifier: SJ-899
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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). 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.

Conditions

Dementia; Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Cortisol

  Cortisol levels measured in saliva samples

  During intervention period

Secondary Outcomes (6)

• Delirium

  During intervention period

• Length of admission

  During intervention period

• Pharmaceutics

  During intervention period

• Mortality

  During intervention period

• Adverse advent

  During intervention period

Study Arms (2)

Intervention group

EXPERIMENTAL

Exposure to 24-hour LED naturalistic lighting

Other: Naturalistic LED light

Control group

SHAM COMPARATOR

Exposure to standard/traditional lighting setting with fluorescent tubes

Other: Standard/traditional lighting

Interventions

Naturalistic LED light OTHER

Naturalistic LED light (bright light therapy) which affects Melanopic Equivalent Daylight Illuminance.

Intervention group

Standard/traditional lighting OTHER

Standard/tradtional lighting environment with fluorescent tubes

Control group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zealand University Hospital: lead
• Technical University of Denmark: collaborator
• University of Copenhagen: collaborator

Related Publications (5)

• 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.

  PMID: 30416392 BACKGROUND

• Figueiro 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.

  PMID: 28534696 BACKGROUND

• Creavin 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.

  PMID: 26760674 BACKGROUND

• Schulz 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.

  PMID: 20334633 BACKGROUND

• Wei 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.

  PMID: 18384586 BACKGROUND

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Central Study Contacts

Martin Ballegaard, MD, PhD

CONTACT

(+45) 47 32 29 09; mbag@regionsjaelland.dk

Lotte Olsen, MSc

CONTACT

(+45) 42 60 10 21; losol@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 10, 2022
• Study Start: September 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: May 1, 2024
• Last Updated: September 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share