Circadian Dysrhythmia, Delirium
Conditions
Keywords
Circadian rhythm, ICU, Acute myocardial infarction, Delirium, Light therapy
Brief summary
By using subjective and objective measurements, the investigators monitor the change of circadian rhythm in Intensive Care Unit (ICU) patients with acute myocardial infarction and the effect of light therapy.
Detailed description
The investigators include 70 patients who are admitted to coronary care unit due to coronary artery disease, with severity between Killip I-III and age between 35-85. Participants are randomly assigned to 2 groups, the experimental group (blue light) and the placebo group (white light). Both groups receive light therapy or white light daily between 8am to 12pm. The investigators use actigraphy and heart rate variation analysis, and check melatonin level as objective measurements. The investigators use delirium scales to evaluate delirium and its severity. The light therapy is stopped once a participant is diagnosed of delirium or transferred, and the investigators keep following participants until discharge to evaluate the prognosis.
Interventions
DEVICEBlue light therapy
Blue light therapy has been proved its efficacy and safety is treatment circadian rhythm disorder as well as other diseases.
OTHERWhite light
White light is used as sham control.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
35 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Diagnosis for admission is acute myocardial infarction with severity between Killip I-III. * Age is between 35-85. * Participants who are willing to participate in the study and sign the informed consent.
Exclusion criteria
* Using sedative hypnotic drugs. * Blindness or severe cataract. * Neurological diseases such as epilepsy, brain injury, or stroke. * Severe mental disorder such as major depressive disorder, bipolar disorder, schizophrenia, intellectual disability or substance use disorders. * Unable to communicate. * Participants who are unwilling to participate in the study or refuse to sign the informed consent. * Participants who are not suitable to include in this study, evaluate by PI or Co-PI.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of the circadian rhythm during admission by actigraphy | an average of 2 weeks of continuous monitoring since baseline till discharge, up to 4 weeks | Actigraphy data |
| Changes of the circadian rhythm during admission by heart-rate-variation-analysis | baseline for 48hours, and 24hours before discharge | heart-rate-variation-analysis data |
| Changes of Melatonin level | collect saliva in the morning and at the night of Day 1 and the day of discharge | Melatonin level |
| Changes of Vitamin D level | blood sampling at Day 1 and the day of discharge | Vitamin D level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Confusion Assessment Method for the Intensive Care Unit | evaluate daily since baseline to discharge, for an average of 2 weeks, up to 4 weeks | Evaluation of delirium and its severity, score range 0-7, and score 0-2 no delirium, 3-5 mild to moderate, 6-7 severe |
| Intensive Care Delirium Screen Checklist | evaluate daily since baseline to discharge, for an average of 2 weeks, up to 4 weeks | Evaluation of delirium and its severity, score range 0-8, and score 4-8 suspected delirium |
Countries
Taiwan
Contacts
Primary ContactWei-Chih Chin
Outcome results
None listed