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

Primary Purpose

Aged, Circadian Rhythm, Cognition

Status
Suspended
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Biocentric light
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Aged

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Skåne University Hospital Malmö

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention biocentric light environment

Control standard light environment

Arm Description

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.

Standard static light environment.

Outcomes

Primary Outcome Measures

Melatonin curve
A change in the phase of the melatonin curve

Secondary Outcome Measures

Sleep
Change in sleep time

Full Information

First Posted
October 26, 2021
Last Updated
May 22, 2023
Sponsor
Region Skane
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1. Study Identification

Unique Protocol Identification Number
NCT05107947
Brief Title
Light in Frail Elderly - the Effect of a Dynamic Light for Sleep and Circadian Rhythm
Acronym
LIFE
Official Title
Light in Frail Elderly - the Effect of a Dynamic Light for Sleep and Circadian Rhythm
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Suspended
Why Stopped
Lack of resources
Study Start Date
October 31, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
This is a randomized, prospective study where the diurnal variation of melatonin as well as sleep-related parameters (sleep duration and sleep quality) will be investigated with regards to light exposure during the hospital stay. Furthermore, it is investigated how psychological and cognitive functions are affected by light intervention and whether this is related to improved sleep or not. The study includes a total of 300 patients over the age of 65 who are cared for in an internal medicine or orthopedic surgery department at Skåne University Hospital in Malmö. The measurement period in the project is intended to be carried out during the period of October 2021-February 2022. Hospital rooms in the orthopedic department and in the medical department constitute the study environment. In all 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. By weighing together spectral distribution and brightness, the circadian stimulus of the light environment can be calculated. The biocentric light provides a light with a high circadian stimulus during the morning and early afternoon. The biocentric light can be turned on (intervention) or off (control). When control setting, the standard normal light constitutes the light environment. In all rooms included in the study, an accurate measurement of light conditions is carried out both with regard to spectral distribution and light intensity. Furthermore, patients will carry light meters to measure the actual amount of light to which patients are exposed. The study includes two arms, an intervention group and a control group. Patients who are assigned to one of the study rooms, and meet the inclusion criteria, will be asked to participate in the study. Patients are randomized to activate the biocentric light environment or standard light environment. The patients who are cared for in a biocentric light environment are included in the intervention group and those who are cared for in rooms with a standard light environment are included in the control group. 300 patients are to be included in the study. Surveys concerning alertness, sleep will be carried out. The frailty and a rapid test for delirium will be assessed. The patients will wear an actiwatch that records their sleep. For a small group of patients, also saliva melatonin will be collected every 4th hour from 7 pm to 11 am for two different nights 3 days apart. The results will be compared between the patients in the intervention group and the control group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aged, Circadian Rhythm, Cognition, Fatigue, Humans, Light, Melatonin, Sleep, Biocentric, Frailty, Karolinska Sleepiness Score, Inflammation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One intervention group and one control group
Masking
None (Open Label)
Masking Description
Interventions constitutes of a different lighting environment therefore not possible to mask.
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention biocentric light environment
Arm Type
Experimental
Arm Description
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.
Arm Title
Control standard light environment
Arm Type
No Intervention
Arm Description
Standard static light environment.
Intervention Type
Other
Intervention Name(s)
Biocentric light
Intervention Description
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.
Primary Outcome Measure Information:
Title
Melatonin curve
Description
A change in the phase of the melatonin curve
Time Frame
Change after three days of biocentric light exposure
Secondary Outcome Measure Information:
Title
Sleep
Description
Change in sleep time
Time Frame
Increased total sleep time after three days of biocentric light exposure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Over the age of 65 years Admitted to one of the included study rooms Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madeleine Selvander, MD, PhD
Organizational Affiliation
Lunds Universitet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Skåne University Hospital Malmö
City
Malmö
ZIP/Postal Code
21428
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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

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