Circadian DysrhythmiaNCT04953767
The Circadian Rhythm of ICU Patients With Acute Myocardial Infraction and the Effect of Light Therapy
A study testing Blue light therapy and White light in people with Circadian Dysrhythmia and Delirium, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Circadian Dysrhythmia, Delirium
- What is being tested?
- Blue light therapy and White light
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 May 2021to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Wei-Chih Chin
Taoyuan City, 333423
Wei-Chih Chin, +886 3 3281200 ext. 3836, auaug0327@cgmh.org.tw
About this study
Official title: The Circadian Rhythm of ICU Patients With Acute Myocardial Infraction and the Effect of Dynamic Light Therapy : A Preliminary Study
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.
Read the 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.
- Conditions
- Circadian Dysrhythmia, Delirium
- Being tested
- Blue light therapy, White light
- Keywords
- Circadian rhythm, ICU, Acute myocardial infarction, Delirium, Light therapy
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue light therapyDevice
Blue light therapy has been proved its efficacy and safety is treatment circadian rhythm disorder as well as other diseases.
White lightOther
White light is used as sham control.
| Study group | Role | What they receive |
|---|---|---|
| Blue light therapy | Experimental | The participants receive blue light therapy for 1 hours, between 8am to 12pm in the morning. Receives: Device: Blue light therapy |
| White light | Sham comparator | The participants receive white light for 1 hour, between 8am to 12pm in the morning. Receives: Other: White light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of the circadian rhythm during admission by actigraphy
Actigraphy data
Measured: an average of 2 weeks of continuous monitoring since baseline till discharge, up to 4 weeks
Changes of the circadian rhythm during admission by heart-rate-variation-analysis
heart-rate-variation-analysis data
Measured: baseline for 48hours, and 24hours before discharge
Changes of Melatonin level
Melatonin level
Measured: collect saliva in the morning and at the night of Day 1 and the day of discharge
Changes of Vitamin D level
Vitamin D level
Measured: blood sampling at Day 1 and the day of discharge
Secondary outcomes (2)
Confusion Assessment Method for the Intensive Care Unit
Evaluation of delirium and its severity, score range 0-7, and score 0-2 no delirium, 3-5 mild to moderate, 6-7 severe
Measured: evaluate daily since baseline to discharge, for an average of 2 weeks, up to 4 weeks
Intensive Care Delirium Screen Checklist
Evaluation of delirium and its severity, score range 0-8, and score 4-8 suspected delirium
Measured: evaluate daily since baseline to discharge, for an average of 2 weeks, up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start12 May 2021
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Circadian DysrhythmiaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei-Chih Chin, Principal investigator, Chang Gung Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953767
- Sponsor's protocol ID
- 201902108A3
- Status last verified
- Aug 2023
- First submitted
- 21 Jun 2021
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Salluh JI, Wang H, Schneider EB, Nagaraja N, Yenokyan G, Damluji A, Serafim RB, Stevens RD. Outcome of delirium in critically ill patients: systematic review and meta-analysis. BMJ. 2015 Jun 3;350:h2538. doi: 10.1136/bmj.h2538.
PubMed 26041151van Maanen A, Meijer AM, van der Heijden KB, Oort FJ. The effects of light therapy on sleep problems: A systematic review and meta-analysis. Sleep Med Rev. 2016 Oct;29:52-62. doi: 10.1016/j.smrv.2015.08.009. Epub 2015 Sep 9.
PubMed 26606319Ono H, Taguchi T, Kido Y, Fujino Y, Doki Y. The usefulness of bright light therapy for patients after oesophagectomy. Intensive Crit Care Nurs. 2011 Jun;27(3):158-66. doi: 10.1016/j.iccn.2011.03.003. Epub 2011 Apr 21.
PubMed 21511473Taguchi T, Yano M, Kido Y. Influence of bright light therapy on postoperative patients: a pilot study. Intensive Crit Care Nurs. 2007 Oct;23(5):289-97. doi: 10.1016/j.iccn.2007.04.004. Epub 2007 Aug 9.
PubMed 17692522Oh J, Cho D, Park J, Na SH, Kim J, Heo J, Shin CS, Kim JJ, Park JY, Lee B. Prediction and early detection of delirium in the intensive care unit by using heart rate variability and machine learning. Physiol Meas. 2018 Mar 27;39(3):035004. doi: 10.1088/1361-6579/aaab07.
PubMed 29376502Osse RJ, Tulen JH, Hengeveld MW, Bogers AJ. Screening methods for delirium: early diagnosis by means of objective quantification of motor activity patterns using wrist-actigraphy. Interact Cardiovasc Thorac Surg. 2009 Mar;8(3):344-8; discussion 348. doi: 10.1510/icvts.2008.192278. Epub 2008 Dec 22.
PubMed 19103609Papaioannou VE, Maglaveras N, Houvarda I, Antoniadou E, Vretzakis G. Investigation of altered heart rate variability, nonlinear properties of heart rate signals, and organ dysfunction longitudinally over time in intensive care unit patients. J Crit Care. 2006 Mar;21(1):95-103; discussion 103-4. doi: 10.1016/j.jcrc.2005.12.007.
PubMed 16616632
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Circadian Rhythm of ICU Patients With Acute Myocardial Infraction and the Effect of Dynamic Light Therapy : A Preliminary Study
- ClinicalTrials.gov ID
- NCT04953767
- Acronym / sponsor ID
- 201902108A3
- Conditions
- Circadian Dysrhythmia, Delirium
- Keywords
- Circadian rhythm, ICU, Acute myocardial infarction, Delirium, Light therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 12 May 2021 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blue light therapy | Experimental | Device: Blue light therapyThe participants receive blue light therapy for 1 hours, between 8am to 12pm in the morning. |
| White light | Sham comparator | Other: White lightThe participants receive white light for 1 hour, between 8am to 12pm in the morning. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blue light therapyBlue light therapy has been proved its efficacy and safety is treatment circadian rhythm disorder as well as other diseases. | Device | Blue light therapy |
| White lightWhite light is used as sham control. | Other | White light |
Primary outcome
Changes of the circadian rhythm during admission by actigraphy
Time frame: 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
Time frame: baseline for 48hours, and 24hours before discharge
heart-rate-variation-analysis data
Changes of Melatonin level
Time frame: collect saliva in the morning and at the night of Day 1 and the day of discharge
Melatonin level
Changes of Vitamin D level
Time frame: blood sampling at Day 1 and the day of discharge
Vitamin D level
2 secondary outcomes
Confusion Assessment Method for the Intensive Care Unit
Time frame: evaluate daily since baseline to discharge, for an average of 2 weeks, up to 4 weeks
Intensive Care Delirium Screen Checklist
Time frame: evaluate daily since baseline to discharge, for an average of 2 weeks, up to 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Background: PubMed 26041151Salluh JI, Wang H, Schneider EB, Nagaraja N, Yenokyan G, Damluji A, Serafim RB, Stevens RD. Outcome of delirium in critically ill patients: systematic review and meta-analysis. BMJ. 2015 Jun 3;350:h2538. doi: 10.1136/bmj.h2538.
- Background: PubMed 26606319van Maanen A, Meijer AM, van der Heijden KB, Oort FJ. The effects of light therapy on sleep problems: A systematic review and meta-analysis. Sleep Med Rev. 2016 Oct;29:52-62. doi: 10.1016/j.smrv.2015.08.009. Epub 2015 Sep 9.
- Background: PubMed 21511473Ono H, Taguchi T, Kido Y, Fujino Y, Doki Y. The usefulness of bright light therapy for patients after oesophagectomy. Intensive Crit Care Nurs. 2011 Jun;27(3):158-66. doi: 10.1016/j.iccn.2011.03.003. Epub 2011 Apr 21.
- Background: PubMed 17692522Taguchi T, Yano M, Kido Y. Influence of bright light therapy on postoperative patients: a pilot study. Intensive Crit Care Nurs. 2007 Oct;23(5):289-97. doi: 10.1016/j.iccn.2007.04.004. Epub 2007 Aug 9.
- Background: PubMed 29376502Oh J, Cho D, Park J, Na SH, Kim J, Heo J, Shin CS, Kim JJ, Park JY, Lee B. Prediction and early detection of delirium in the intensive care unit by using heart rate variability and machine learning. Physiol Meas. 2018 Mar 27;39(3):035004. doi: 10.1088/1361-6579/aaab07.
- Background: PubMed 19103609Osse RJ, Tulen JH, Hengeveld MW, Bogers AJ. Screening methods for delirium: early diagnosis by means of objective quantification of motor activity patterns using wrist-actigraphy. Interact Cardiovasc Thorac Surg. 2009 Mar;8(3):344-8; discussion 348. doi: 10.1510/icvts.2008.192278. Epub 2008 Dec 22.
- Background: PubMed 16616632Papaioannou VE, Maglaveras N, Houvarda I, Antoniadou E, Vretzakis G. Investigation of altered heart rate variability, nonlinear properties of heart rate signals, and organ dysfunction longitudinally over time in intensive care unit patients. J Crit Care. 2006 Mar;21(1):95-103; discussion 103-4. doi: 10.1016/j.jcrc.2005.12.007.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei-Chih Chin principal investigator
Chang Gung Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blue light therapy and White light in people with Circadian Dysrhythmia and Delirium, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei-Chih Chin (+886 3 3281200 ext. 3836, auaug0327@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of the circadian rhythm during admission by actigraphy (time frame: an average of 2 weeks of continuous monitoring since baseline till discharge, up to 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04953767, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.