Clinical Trial Details
— Status: Suspended
Administrative data
| NCT number |
NCT05107947 |
| Other study ID # |
2021-02765 |
| Secondary ID |
|
| Status |
Suspended |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 31, 2022 |
| Est. completion date |
September 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Region Skane |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
