Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05107947
Study type Interventional
Source Region Skane
Contact
Status Suspended
Phase N/A
Start date October 31, 2022
Completion date September 2025

See also
  Status Clinical Trial Phase
Completed NCT03995979 - Inflammation and Protein Restriction N/A
Completed NCT03255187 - Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT03577223 - Egg Effects on the Immunomodulatory Properties of HDL N/A
Completed NCT04383561 - Relationship Between LRG and Periodontal Disease N/A
Active, not recruiting NCT03622632 - Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
Completed NCT06216015 - Exercise Training and Kidney Transplantation N/A
Completed NCT04856748 - Nomogram to Diagnose Prostatic Inflammation (PIN) in Men With Lower Urinary Tract Symptoms
Completed NCT05529693 - Efficacy of a Probiotic Strain on Level of Markers of Inflammation in an Elderly Population N/A
Recruiting NCT05415397 - Treating Immuno-metabolic Depression With Anti-inflammatory Drugs Phase 3
Recruiting NCT05670301 - Flemish Joint Effort for Biomarker pRofiling in Inflammatory Systemic Diseases N/A
Recruiting NCT04543877 - WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study Early Phase 1
Recruiting NCT05775731 - Markers of Inflammation and of the Pro-thrombotic State in Hospital Shift and Day Workers
Completed NCT03859934 - Metabolic Effects of Melatonin Treatment Phase 1
Completed NCT03429920 - Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors N/A
Completed NCT06065241 - Quantifiably Determine if the Botanical Formulation, LLP-01, Has a Significant Clinical Effect on Proteomic Inflammatory Biomarkers and Epigenetic Changes in Healthy, Older Individuals. N/A
Completed NCT05864352 - The Role of Dietary Titanium Dioxide on the Human Gut Microbiome and Health
Completed NCT03318731 - Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation in Untrained Males N/A
Not yet recruiting NCT06134076 - Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota N/A
Not yet recruiting NCT05910489 - Micro and Nanoplastics in Greenhouse Workers: Biomarkers of Exposure and Effect