Circadian Rhythm Sleep Disorder, UnspecifiedNCT03568045
Feasibility Pilot of Bright Light in the Intensive Care Unit
A study testing standard light, 10,000 lux bright light, 4 hours and 10,000 lux bright light, 8 hours in people with Circadian Rhythm Sleep Disorder, Unspecified, run by Yale University at 1 site in United States.
Trial summary
To evaluate the feasibility of providing daytime bright light in the ICU in a pilot randomized controlled trial. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Circadian Rhythm Sleep Disorder, Unspecified
- What is being tested?
- standard light, 10,000 lux bright light, 4 hours and 10,000 lux bright light, 8 hours
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2018to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 ≥24 hours after enrollment
- Age ≥50 years
- History of hypertension based on chart review and presence of 1 or more home blood pressure medications
- Able to understand English
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) OR 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 (<1% population) or blind/disease of the optic nerve
- Current history of substance abuse including alcohol (use in last 30 days)
- Current or recent (last 1 year) shiftwork
- Home medications include: melatonin, melatonin agonist
Show all 11Show fewer
- Transferred from an outside hospital, long-term care, rehabilitation, or acute care facility
- History of bipolar disease (Bright light therapy possibly unsafe in this population).
- Paralyzed (due to injury, disease or medications)
- Diagnosed with hepatic encephalopathy in the setting of end-stage liver disease
- Homeless
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 evaluate the feasibility of providing daytime bright light in the ICU in a pilot randomized controlled trial.
Read the detailed description
To evaluate the feasibility of providing daytime bright light in the ICU in a pilot randomized controlled trial. Feasibility will be assessed via the following metrics: daytime bright light is acceptable and tolerable to patients and has high fidelity and sustainability as an intervention.
- Being tested
- standard light, 10,000 lux bright light, 4 hours, 10,000 lux bright light, 8 hours
- Keywords
- circadian misalignment, entrainment, zeitgeber, bright light, critical illness
- Medical subject headings
- Sleep Disorders, Circadian Rhythm, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard lightDevice
usual care
10,000 lux bright light, 4 hoursDevice
Also called Bright light, 4 hours
Bright light will be delivered by a free-standing 10,000 lux device that will be positioned next to the patient's head of bed. At the estimated distance of 36 inches from light source to the patient, we anticipate approximately a 1,250 lux dose at the patient's eye. Light will be delivered from 8am to noon.
10,000 lux bright light, 8 hoursDevice
Also called Bright light, 8 hours
Bright light will be delivered by a free-standing 10,000 lux device that will be positioned next to the patient's head of bed. At the estimated distance of 36 inches from light source to the patient, we anticipate approximately a 1,250 lux dose at the patient's eye. Light will be delivered from 8am to 4pm.
| Study group | Role | What they receive |
|---|---|---|
| Usual care, standard light | Active comparator | Patients will be enrolled within 30 hours of noon on enrollment day (e.g. at or after 6am 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: standard light |
| 10,000 lux bright light, 4 hours | Experimental | Patients will be enrolled within 30 hours of noon on enrollment day (e.g. at or after 6am 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 8am to noon starting on study day 2 and continuing through study day 5. Bright light exposure will occur in the Intensive Care Unit (ICU) and on the floor if the patient is transferred.
Feasibility metrics will be collected. Receives: Device: 10,000 lux bright light, 4 hours |
| 10,000 lux bright light, 8 hours | Experimental | Patients will be enrolled within 30 hours of noon on enrollment day (e.g. at or after 6am 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 8am to 4pm starting on study day 2 and continuing through study day 5. Bright light exposure will occur in the Intensive Care Unit (ICU) and on the floor if the patient is transferred.
Feasibility metrics will be collected. Receives: Device: 10,000 lux bright light, 8 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance (Time): Percent of Intended Treatment Hours That Patient Continues With the Delivery of Bright Light
Percent of intended treatment hours that patient continues with the delivery of bright light once exposed to bright light.
Measured: Study Day 2-5
Secondary outcomes (4)
Acceptance: Percent of Patients/Surrogates Who Agree to Bright Light When Initially Described
Percent of patients/surrogates who agree to study enrollment including bright light when initially described to them.
Measured: Study Day 1 (enrollment)
Tolerance (Symptoms): Percent of Patients Who Develop Eye Strain, Headache or Visual Disturbance.
Percent of patients who develop eye strain, headache or visual disturbance.
Measured: Study Day 2-5
Fidelity: Percent of Time Per Day That Device Delivers the Planned Dose of Light
Percent of time per day that device delivers the planned dose of light (out of 4 or 8 hours depending on intervention arm).
Measured: Study Day 2-5
Sustainability: Percent of Intended Intervention Days That the Device is Used.
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 2-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start3 Dec 2018
- Primary completion31 Mar 2023
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Circadian Rhythm Sleep Disorder, UnspecifiedStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a pilot randomized control trial of 3 cohort groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Melissa Knauert, MD, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568045
- Sponsor's protocol ID
- 2000022284
- Other IDs
- 1K23HL138229-01A1, 1R03HL157009-01
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2018
- Last updated
- 17 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Pilot of Bright Light in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03568045
- Acronym / sponsor ID
- 2000022284
- Keywords
- circadian misalignment, entrainment, zeitgeber, bright light, critical illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Posted 17 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the feasibility of providing daytime bright light in the ICU in a pilot randomized controlled trial.
Detailed description
To evaluate the feasibility of providing daytime bright light in the ICU in a pilot randomized controlled trial. Feasibility will be assessed via the following metrics: daytime bright light is acceptable and tolerable to patients and has high fidelity and sustainability as an intervention.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- a pilot randomized control trial of 3 cohort groups.
| Arm | Type | Receives |
|---|---|---|
| Usual care, standard light | Active comparator | Device: standard lightPatients will be enrolled within 30 hours of noon on enrollment day (e.g. at or after 6am 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. |
| 10,000 lux bright light, 4 hours | Experimental | Device: 10,000 lux bright light, 4 hoursPatients will be enrolled within 30 hours of noon on enrollment day (e.g. at or after 6am 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 8am to noon starting on study day 2 and continuing through study day 5. Bright light exposure will occur in the Intensive Care Unit (ICU) and on the floor if the patient is transferred. Feasibility metrics will be collected. |
| 10,000 lux bright light, 8 hours | Experimental | Device: 10,000 lux bright light, 8 hoursPatients will be enrolled within 30 hours of noon on enrollment day (e.g. at or after 6am 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 8am to 4pm starting on study day 2 and continuing through study day 5. Bright light exposure will occur in the Intensive Care Unit (ICU) and on the floor if the patient is transferred. Feasibility metrics will be collected. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hospital admission ≤30 hours at noon on enrollment day
- Expected to say in the Medical Intensive Care Unit ≥24 hours after enrollment
- Age ≥50 years
- History of hypertension based on chart review and presence of 1 or more home blood pressure medications
- Able to understand English
Key exclusion criteria (11 listed)
- At significant risk for pre-existing circadian abnormalities:
- Home medications include: melatonin, melatonin agonist
- Transferred from an outside hospital, long-term care, rehabilitation, or acute care facility
- History of bipolar disease (Bright light therapy possibly unsafe in this population).
- Paralyzed (due to injury, disease or medications)
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 |
|---|---|---|
| standard lightusual care | Device | Usual care, standard light |
| 10,000 lux bright light, 4 hoursAlso: Bright light, 4 hoursBright light will be delivered by a free-standing 10,000 lux device that will be positioned next to the patient's head of bed. At the estimated distance of 36 inches from light source to the patient, we anticipate approximately a 1,250 lux dose at the patient's eye. Light will be delivered from 8am to noon. | Device | 10,000 lux bright light, 4 hours |
| 10,000 lux bright light, 8 hoursAlso: Bright light, 8 hoursBright light will be delivered by a free-standing 10,000 lux device that will be positioned next to the patient's head of bed. At the estimated distance of 36 inches from light source to the patient, we anticipate approximately a 1,250 lux dose at the patient's eye. Light will be delivered from 8am to 4pm. | Device | 10,000 lux bright light, 8 hours |
Primary outcome
Tolerance (Time): Percent of Intended Treatment Hours That Patient Continues With the Delivery of Bright Light
Time frame: Study Day 2-5
Percent of intended treatment hours that patient continues with the delivery of bright light once exposed to bright light.
4 secondary outcomes
Acceptance: Percent of Patients/Surrogates Who Agree to Bright Light When Initially Described
Time frame: Study Day 1 (enrollment)
Tolerance (Symptoms): Percent of Patients Who Develop Eye Strain, Headache or Visual Disturbance.
Time frame: Study Day 2-5
Fidelity: Percent of Time Per Day That Device Delivers the Planned Dose of Light
Time frame: Study Day 2-5
Sustainability: Percent of Intended Intervention Days That the Device is Used.
Time frame: Study Day 2-5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 standard light, 10,000 lux bright light, 4 hours and 10,000 lux bright light, 8 hours in people with Circadian Rhythm Sleep Disorder, Unspecified, 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 5 inclusion and 11 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 17 Jun 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?
Yes. Results are posted in the registry (first posted 17 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Tolerance (Time): Percent of Intended Treatment Hours That Patient Continues With the Delivery of Bright Light (time frame: Study Day 2-5). 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 17 Jun 2024.