Circadian Rhythm DisordersNCT03684460
Daytime Bright Light, Circadian Abnormalities, and Delirium in Medical ICU Patients
A study testing Daytime Bright Light and Usual Light in people with Circadian Rhythm Disorders, run by Yale University at 1 site in United States.
Trial summary
To determine if daytime bright light will promote circadian alignment and shorten or prevent delirium. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Circadian Rhythm Disorders
- What is being tested?
- Daytime Bright Light and Usual Light
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2019to 28 Mar 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospital admission ≤30 hours at noon on enrollment day
- Expected to say in the Medical Intensive Care Unit (MICU) ≥24 hours after enrollment
- Age ≥50 years
Who cannot join
- At significant risk for pre-existing circadian abnormalities:
- Severe chronic brain injury (Injury greater than 30 days ago resulting in the inability to live independently)
- Acute brain injury of any severity (Injury less than 30 days ago including acute intracranial bleed, traumatic brain injury, central nervous system infection, tumor)
- Documented circadian disorder or blind/disease of the optic nerve
- Current history of substance abuse including alcohol (use in last 30 days)
- 3. Transferred from an outside hospital. 4. History of bipolar disease 5. Paralyzed (due to injury, disease or medications)
- Enrolled patients who do not stay in the MICU through 13:00 of Study Day 2 will be excluded; patients transferred from the MICU to the floor between 22:00 and 05:00 on subsequent study nights will continue in the study but be excluded from the primary analysis (estimated 10% of patients).
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital, York Street Campus
New Haven, Connecticut, 06520
About this study
To determine if daytime bright light will promote circadian alignment and shorten or prevent delirium.
Read the detailed description
To determine if daytime bright light will promote circadian alignment and shorten or prevent delirium. The objective is to conduct a randomized controlled trial to determine if a circadian entrainment intervention, daytime bright light, will promote circadian alignment and reduce days of delirium
- Conditions
- Circadian Rhythm Disorders
- Being tested
- Daytime Bright Light, Usual Light
- Keywords
- circadian misalignment, bright light, entrainment, zeitgeber, critical illness, delirium, actigraphy
- Medical subject headings
- Chronobiology Disorders, Critical Illness, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daytime Bright LightDevice
Daytime Bright Light (DBL) will be delivered by a free-standing apparatus set to deliver 10,000 lux. The device will be placed at the bedside within 36 inches of the patient's head and is expected to provide at least 1,250 lux at the angle of gaze. To remain in the study, the patient must be in the Intensive Care Unit (ICU) through 13:00 on day 2 (e.g., the first day of potential intervention). After day 2, DBL and other study activities will continue if the patient is transferred out of the ICU to the general medical floor.
Usual LightDevice
Usual care lighting in ICU.
To remain in the study usual care patients must also remain in the MICU through 13:00 on day 2.
| Study group | Role | What they receive |
|---|---|---|
| Bright Light | Experimental | Intervention: Daytime Bright Light
Patients will be eligible if they were admitted within 30 hours of noon on enrollment day (e.g. at or after 06:00 on the prior calendar day). Enrollment will occur before noon, and the day of enrollment is termed study day 1.
Patients will undergo monitoring (light levels, circadian alignment), starting on study day 1. Patients will be exposed to bright light from 09:00 to 13:00 starting on study day 2 and continuing through study day 5 or MICU discharge whichever is longer up to 30 days. Bright light exposure will occur in the Intensive Care Unit (ICU) and on the floor, if the patient is transferred (prior to study day 5). Feasibility metrics will also be collected. Receives: Device: Daytime Bright Light |
| Usual Light | Active comparator | Intervention: Usual Care
Patients will be eligible if they were admitted within 30 hours of noon on enrollment day (e.g. at or after 06:00 on the prior calendar day). Enrollment will occur before noon, and the day of enrollment is termed study day 1.
Patients will undergo monitoring (light levels, circadian alignment), but otherwise, have usual care. Receives: Device: Usual Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circadian Alignment
The primary circadian outcome will be the proportion of daytime activity out of total activity (daytime proportion). Rest-activity patterns will be measured with the Actiwatch Spectrum (Philips Healthcare, Netherlands) set at 30-second epochs and placed on the patient's wrist.
Enrolled patients who do not stay in the MICU through 13:00 of Study Day 2 will be excluded from all analysis.
Measured: Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
Days of Delirium
The approach is to measure days of delirium in our patient cohort. After enrollment, the investigators will check patients daily for delirium until hospital discharge or day 30.
Measured: Study Day 1-30 (patients will be censored at hospital discharge)
Secondary outcomes (10)
Circadian Alignment, Secondary Measures, Body surface temperature gradient
The investigators will include additional measures of circadian alignment in our analysis: continuous body surface temperature gradient.
Measured: Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
Circadian Alignment, Secondary Measures, Continous Heart Rate
The investigators will include additional measures of circadian alignment in our analysis: continuous heart rate.
Measured: Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
Circadian Alignment, Secondary Measures, urinary 6-sulfatoxymelatonin.
The investigators will include additional measures of circadian alignment in our analysis: urinary 6-sulfatoxymelatonin (for patients making sufficient urine and with an indwelling urinary catheter).
Measured: Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
Feasibility, Patient Acceptance
Percent of patients/surrogates who agree to bright light when initially described to them.
Measured: Study Day 1
Feasibility, Patient Tolerance Time
Percent of intended treatment hours that patient continues with the delivery of bright light once exposed to bright light.
Measured: Study Day 2-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
Feasibility, Patient Tolerance Symptoms
Percent of patients who develop eyestrain, headache or visual disturbance (combined outcome).
Measured: Study Day 2-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
Feasibility, Intervention Fidelity
Percent of time per day that device delivers the planned dose of light.
Measured: Study Day 2-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
Feasibility, Intervention Sustainability
Percent of intended intervention days that the device is used. For this metric, days that the patient refuses bright light will not be included in "intended intervention days."
Measured: Study Day 2-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
Total Sleep
The investigators will measure (and control for) the total amount of sleep (sleep quantity) via actigraphy.
Measured: Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
Sleep Efficiency
The investigators will measure (and control for) overnight sleep efficiency (sleep quality) via actigraphy.
Measured: Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start8 Jul 2019
- Primary completion28 Mar 2024
- Study completion28 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circadian Rhythm DisordersStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Model description
- randomized controlled trial with 2 cohorts
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa Knauert, MD, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684460
- Sponsor's protocol ID
- 2000023033
- Other IDs
- 000
- Status last verified
- May 2024
- First submitted
- 5 Jun 2018
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daytime Bright Light, Circadian Abnormalities, and Delirium in Medical ICU Patients
- ClinicalTrials.gov ID
- NCT03684460
- Acronym / sponsor ID
- 2000023033
- Conditions
- Circadian Rhythm Disorders
- Keywords
- circadian misalignment, bright light, entrainment, zeitgeber, critical illness, delirium, actigraphy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 25 Sep 2018 (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.
To determine if daytime bright light will promote circadian alignment and shorten or prevent delirium.
Detailed description
To determine if daytime bright light will promote circadian alignment and shorten or prevent delirium. The objective is to conduct a randomized controlled trial to determine if a circadian entrainment intervention, daytime bright light, will promote circadian alignment and reduce days of delirium
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled trial with 2 cohorts
| Arm | Type | Receives |
|---|---|---|
| Bright Light | Experimental | Device: Daytime Bright LightIntervention: Daytime Bright Light Patients will be eligible if they were admitted within 30 hours of noon on enrollment day (e.g. at or after 06:00 on the prior calendar day). Enrollment will occur before noon, and the day of enrollment is termed study day 1. Patients will undergo monitoring (light levels, circadian alignment), starting on study day 1. Patients will be exposed to bright light from 09:00 to 13:00 starting on study day 2 and continuing through study day 5 or MICU discharge whichever is longer up to 30 days. Bright light exposure will occur in the Intensive Care Unit (ICU) and on the floor, if the patient is transferred (prior to study day 5). Feasibility metrics will also be collected. |
| Usual Light | Active comparator | Device: Usual LightIntervention: Usual Care Patients will be eligible if they were admitted within 30 hours of noon on enrollment day (e.g. at or after 06:00 on the prior calendar day). Enrollment will occur before noon, and the day of enrollment is termed study day 1. Patients will undergo monitoring (light levels, circadian alignment), but otherwise, have usual care. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hospital admission ≤30 hours at noon on enrollment day
- Expected to say in the Medical Intensive Care Unit (MICU) ≥24 hours after enrollment
- Age ≥50 years
Key exclusion criteria (7 listed)
- At significant risk for pre-existing circadian abnormalities:
- 3. Transferred from an outside hospital. 4. History of bipolar disease 5. Paralyzed (due to injury, disease or medications)
- Enrolled patients who do not stay in the MICU through 13:00 of Study Day 2 will be excluded; patients transferred from the MICU to the floor between 22:00 and 05:00 on subsequent study nights will continue in the study but be excluded from the primary analysis (estimated 10% of patients).
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 |
|---|---|---|
| Daytime Bright LightDaytime Bright Light (DBL) will be delivered by a free-standing apparatus set to deliver 10,000 lux. The device will be placed at the bedside within 36 inches of the patient's head and is expected to provide at least 1,250 lux at the angle of gaze. To remain in the study, the patient must be in the Intensive Care Unit (ICU) through 13:00 on day 2 (e.g., the first day of potential intervention). After day 2, DBL and other study activities will continue if the patient is transferred out of the ICU to the general medical floor. | Device | Bright Light |
| Usual LightUsual care lighting in ICU. To remain in the study usual care patients must also remain in the MICU through 13:00 on day 2. | Device | Usual Light |
Primary outcome
Circadian Alignment
Time frame: Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
The primary circadian outcome will be the proportion of daytime activity out of total activity (daytime proportion). Rest-activity patterns will be measured with the Actiwatch Spectrum (Philips Healthcare, Netherlands) set at 30-second epochs and placed on the patient's wrist. Enrolled patients who do not stay in the MICU through 13:00 of Study Day 2 will be excluded from all analysis.
Days of Delirium
Time frame: Study Day 1-30 (patients will be censored at hospital discharge)
The approach is to measure days of delirium in our patient cohort. After enrollment, the investigators will check patients daily for delirium until hospital discharge or day 30.
10 secondary outcomes
Circadian Alignment, Secondary Measures, Body surface temperature gradient
Time frame: Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
Circadian Alignment, Secondary Measures, Continous Heart Rate
Time frame: Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
Circadian Alignment, Secondary Measures, urinary 6-sulfatoxymelatonin.
Time frame: Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
Feasibility, Patient Acceptance
Time frame: Study Day 1
Feasibility, Patient Tolerance Time
Time frame: Study Day 2-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
Feasibility, Patient Tolerance Symptoms
Time frame: Study Day 2-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
Feasibility, Intervention Fidelity
Time frame: Study Day 2-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
Feasibility, Intervention Sustainability
Time frame: Study Day 2-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
Total Sleep
Time frame: Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
Sleep Efficiency
Time frame: Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
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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.
Melissa Knauert, MD, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daytime Bright Light and Usual Light in people with Circadian Rhythm Disorders, run by Yale University at 1 site in United States.
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: finished, as of the sponsor's last update on 23 May 2024. 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 United States. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circadian Alignment (time frame: Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2024.