Circadian Adjusted LED Light's Effect in People Living in Elderly Housing

NCT03263234 | Completed DMC

• 1 other identifier: Lightel
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Europe is undergoing a demographic change with a rapidly growing population of 65 years+. This challenges municipalities and hospitals as the ageing citizens need care and treatment due to an age-related decline in physical and mental capacity. Therefore municipalities are experiencing a growing need for sufficient and customized housing, which can support the elderly citizens in sustaining well-being and health along with preventing functional decline. Well-fare technologies, such as Circadian adjusted LED-based lighting (CALED), are suggested as a remedy for this. To obtain proper visual sharpness and better contrast, people of older age require heightened light levels due to age-related failing vision. Furthermore, inappropriate light at night disrupts not only sleep but also the timing of the circadian rhythm, with negative consequences on cognition and emotions. Therefore CALED is being increasingly considered for use in hospitals and elderly housing because of its wide spectrum of wavelengths, good contrast and fast switching, and possibility to support a normalised circadian rhythm. Lighting based on LED has been shown to improve the quality of sleep and to improve well-being in the elderly. However, it is not known whether CALED mimicking a normal circadian rhythm has the same benefits for elderly persons with frailty or dementia. The investigators therefore want to test the effects of CALED in elderly people with frailty and mobility disabilities and/or dementia living in elderly housing. The investigators hypothesise that CALED can improve sleep and well-being in both elderly with frailty and dementia.

Conditions

Elderly Housing Residents With Frailty or Dementia

Outcome Measures

Primary Outcomes (2)

• The average difference in Pittsburgh Sleep Quality Index (PSQI) between the end of the intervention period and the end of the control period assessed by the both participants and by staff at the nursing home.

  PSQI is a measure of sleep quality consisting of 19 self-report items. Both participants and staff at the nursing home that knows the participant well evaluate the PSQI, since the participants exhibit various degrees of dementia that may affect their ability to answer the PSQI. Participants and staff indicate the amount of sleep obtained as well as factors interfering with the sleep of the participant. The subscale scores of the PSQI are summed to a total score of 0 to 21 with higher scores indicating poorer sleep quality. PSQI is assessed at baseline, in the 4th and 8th week of the intervention period, and in the 4th and 8th week of the control period. The investigators report estimates for the 8th week assessement by participants and staff, independently. Data from both the 4th and 8th week assessment will be included in the statistical model.

  End of intervention period (8th week assessment), end of control period (8th week assessment)

• The average difference in plasma soluble urokinase plasminogen receptor (suPAR) between the end of the intervention period and the end of the control period.

  suPAR is a stable unspecific plasma biomarker. Elevated suPAR levels are associated with morbidity and mortality, and with unhealthy lifestyle, low muscle mass, lower physical performance, and depression. suPAR is measured in plasma using the commercially available suPARnostic ELISA from Virogates. Plasma samples are stored in a biobank at -80°C, and measured after study completion. suPAR is assessed at baseline, in the 4th and 8th week of the intervention period, and in the 4th and 8th week of the control period. The primary analysis will follow the intention-to-treat principle (using multiple imputations). The investigators report estimates for the 8th week. Data from both the 4th and 8th week assessment will be included in the statistical model.

  End of intervention period (8th week assessment), end of control period (8th week assessment)

Secondary Outcomes (8)

• The average difference in 24-hour mobility between the end of the intervention period and the end of the control period.

  : End of intervention period (8th week assessment), end of control period (8th week assessment)

• The average difference in Epwoth Sleepiness Scale between the end of the intervention period and the end of the control period assessed by the both participants and by staff at the nursing home.

  End of intervention period (8th week assessment), end of control period (8th week assessment)

• The average difference in inflammatory biomarkers such as interleukin (IL)-6, IL-10, soluble CD14, and C reactive protein between the end of the intervention period and the end of the control period.

  End of intervention period (8th week assessment), end of control period (8th week assessment)

• The average difference in endocrinologic biomarkers such as insulin, glucose, cortisol, leptin and melatonin between the end of the intervention period and the end of the control period

  End of intervention period (8th week assessment), end of control period (8th week assessment)

• The average difference in the Mini Mental State Examination between the end of the intervention period and the end of the control period

  End of intervention period (8th week assessment), end of control period (8th week assessment)

Other Outcomes (2)

• The average difference in mini nutritional assessment (MNA) between the end of the intervention period and the end of the control period

  End of intervention period (8th week assessment), end of control period (8th week assessment)

• The average difference in eyesight between the end of the intervention period and the end of the control period

  End of intervention period (8th week assessment), end of control period (8th week assessment)

Study Arms (3)

Group 1

ACTIVE COMPARATOR

Group 1 consists of elderly people with frailty and/or dementia living in elderly housing in Sundhedshuset, Albertslund, Denmark, and who are having CALED installed. Group 1 starts the 8 week control period and ends with the intervention consisting of 8 weeks of circadian adjusted LED-based lighting (CALED).

Other: 8 weeks of circadian adjusted LED-based lighting (CALED)

Group 2

ACTIVE COMPARATOR

Group 2 consists of elderly people with frailty and/or dementia living in elderly housing in Sundhedshuset, Albertslund, Denmark, and who are having CALED installed. Group 2 starts with the intervention consisting of 8 weeks of circadian adjusted LED-based lighting (CALED) and ends with the 8 week control period

Other: 8 weeks of circadian adjusted LED-based lighting (CALED)

Group 3. Control group

NO INTERVENTION

Group 3 consists of elderly people with frailty living in elderly housing in Sundhedshuset, Albertslund, Denmark, and who are not having CALED installed. This group serves as a control for: * Physiological or mental decline in participants during the study period * Seasonal variation

Interventions

8 weeks of circadian adjusted LED-based lighting (CALED) OTHER

The luminaires are installed before the beginning of either the control or the intervention period. During the control period (8 weeks) the luminaires have normal light. During the intervention period (8 weeks) the luminaires have CALED. Cromaviso will calibrate CALED to mimic circadian rhythm according to the latest knowledge about the light phase-response curve for elderly.

Group 1; Group 2

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Group 1 and 2: Frail elderly (+65 years) and elderly (+50 years) with dementia, who live in the flats/rooms in Sundhedshuset, Albertslund, Denmark that have been chosen for a test installation of CALED will be invited to participate.
• Group 3: Frail elderly (+65 years) who live in the flats/rooms in Sundhedshuset, Albertslund, Denmark that have not been chosen for a test installation of CALED will be invited to participate.

You may not qualify if:

• Terminal illness

Sponsors & Collaborators

• Ove Andersen: lead
• Chromaviso A/S: collaborator
• Albertslund Kommune: collaborator
• Aalborg University: collaborator
• Gate 21: collaborator

Study Sites (1)

Clinical Research Centre

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

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

Study Officials

• Ove Andersen, PhD, DMSc

  Clinical Research Centre, Copenhagen University Hospital Hvidovre, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Director, MD, PhD, DMSc

Study Record Dates

• First Submitted: August 18, 2017
• First Posted: August 28, 2017
• Study Start: September 29, 2017
• Primary Completion: April 21, 2018
• Study Completion: April 22, 2018
• Last Updated: March 12, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)