Light in Frail Elderly - the Effect of a Dynamic Light for Sleep and Circadian Rhythm

NCT05107947 | Recruiting

• 1 other identifier: 2021-02765
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Aged; Circadian Rhythm; Fatigue; Melatonin; Sleep; Biocentric; Frailty; Karolinska Sleepiness Score; Inflammation; Cognition; Humans; Light

Outcome Measures

Primary Outcomes (1)

• Melatonin curve

  A change in the phase of the melatonin curve

  Change after three days of biocentric light exposure

Secondary Outcomes (1)

• Sleep

  Increased total sleep time after three days of biocentric light exposure

Study Arms (2)

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.

Other: Biocentric light

Control standard light environment

NO INTERVENTION

Standard static light environment.

Interventions

Biocentric light OTHER

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.

Intervention biocentric light environment

Eligibility Criteria

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

You may qualify if:

• Over the age of 65 years
• Admitted to one of the included study rooms

You may not qualify if:

• Overdose addictive substance
• Acute neurological disease
• Melatonin treatment
• Probable survival \<5 days
• Severe visual impairment that makes reading impossible
• Age \<65 years
• 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

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Skåne University Hospital Malmö

Malmo, 21428, Sweden

RECRUITING

MeSH Terms

Conditions

Fatigue; Frailty; Inflammation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Madeleine Selvander, MD, PhD

  Lunds Universitet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madeleine Selvander, MD, PhD

CONTACT

+4640 33 32 27; madeleine.selvander@med.lu.se

Klas Sjöberg, MD,PhD

CONTACT

+4640 33 32 27; klas.sjoberg@med.lu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Interventions constitutes of a different lighting environment therefore not possible to mask.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One intervention group and one control group

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 4, 2021
• Study Start: October 31, 2022
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)