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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cognitive Impairment; Dementia
• Intervention / Treatment: Other: Naturalistic LED light; Other: Standard/traditional lighting

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martin Ballegaard, MD, PhD; Phone Number: (+45) 47 32 29 09; Email: mbag@regionsjaelland.dk
• Study Contact Backup: Name: Lotte Olsen, MSc; Phone Number: (+45) 42 60 10 21; Email: losol@regionsjaelland.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Exposure to 24-hour LED naturalistic lighting	Other: Naturalistic LED light; Naturalistic LED light (bright light therapy) which affects Melanopic Equivalent Daylight Illuminance.
Sham Comparator: Control group; Exposure to standard/traditional lighting setting with fluorescent tubes	Other: Standard/traditional lighting; Standard/tradtional lighting environment with fluorescent tubes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cortisol	Cortisol levels measured in saliva samples	During intervention period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delirium	Delirium measured in CAM score	During intervention period
Length of admission	Length of admission collected from patient charts	During intervention period
Pharmaceutics	Use of pharmaceutics during hospitalization. Collected from patient charts.	During intervention period
Mortality	Mortality rates collected from patient charts	During intervention period
Adverse advent	Adverse advent, e.g. patient related fall incidents, collected from patient charts	During intervention period
Constant observation	Need of constant observation from health professionals, collected from patient charts	During intervention period

Collaborators and Investigators

• Sponsor: Zealand University Hospital
• Collaborators: University of Copenhagen; Technical University of Denmark

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 10, 2022

Study Record Updates

• Last Update Posted (Actual): September 10, 2022
• Last Update Submitted That Met QC Criteria: September 6, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Cognition Disorders; Dementia; Cognitive Dysfunction
• Other Study ID Numbers: SJ-899

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No