Skip to main content
OpenTrials
Completed

NCT Number: NCT03684460

Daytime Bright Light, Circadian Abnormalities, and Delirium in Medical ICU Patients

To determine if daytime bright light will promote circadian alignment and shorten or prevent delirium.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale New Haven Hospital, York Street Campus

New Haven, Connecticut, 06520, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • 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).

Treatment and study plan

Daytime Bright Light

Device

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 Light

Device

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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).

    The investigators will include additional measures of circadian alignment in our analysis: continuous body surface temperature gradient.

  2. 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).

    The investigators will include additional measures of circadian alignment in our analysis: continuous heart rate.

  3. 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).

    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).

  4. Feasibility, Patient Acceptance

    Time frame: Study Day 1

    Percent of patients/surrogates who agree to bright light when initially described to them.

  5. 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).

    Percent of intended treatment hours that patient continues with the delivery of bright light once exposed to bright light.

  6. 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).

    Percent of patients who develop eyestrain, headache or visual disturbance (combined outcome).

  7. 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).

    Percent of time per day that device delivers the planned dose of light.

  8. 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).

    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."

  9. 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).

    The investigators will measure (and control for) the total amount of sleep (sleep quantity) via actigraphy.

  10. 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).

    The investigators will measure (and control for) overnight sleep efficiency (sleep quality) via actigraphy.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Sep 25, 2018
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.