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Completed

NCT Number: NCT03568045

Feasibility Pilot of Bright Light in the Intensive Care Unit

To evaluate the feasibility of providing daytime bright light in the ICU in a pilot randomized controlled trial.

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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 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.

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 ≥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

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) 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
  • 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

Treatment and study plan

standard light

Device

usual care

10,000 lux bright light, 4 hours

Device

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.

Other names: Bright light, 4 hours

10,000 lux bright light, 8 hours

Device

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.

Other names: Bright light, 8 hours

Primary outcomes

  1. 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.

Secondary outcomes

  1. Acceptance: Percent of Patients/Surrogates Who Agree to Bright Light When Initially Described

    Time frame: Study Day 1 (enrollment)

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

  2. Tolerance (Symptoms): Percent of Patients Who Develop Eye Strain, Headache or Visual Disturbance.

    Time frame: Study Day 2-5

    Percent of patients who develop eye strain, headache or visual disturbance.

  3. Fidelity: Percent of Time Per Day That Device Delivers the Planned Dose of Light

    Time frame: Study Day 2-5

    Percent of time per day that device delivers the planned dose of light (out of 4 or 8 hours depending on intervention arm).

  4. Sustainability: Percent of Intended Intervention Days That the Device is Used.

    Time frame: Study Day 2-5

    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."

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Jun 26, 2018
Registry last updated
Jun 17, 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.

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