N/A
N=16
Feasibility Pilot of Bright Light in the Intensive Care Unit
Circadian Rhythm Sleep Disorder, Unspecified
Bottom Line
View on ClinicalTrials.gov: NCT03568045 ↗Enrolled (actual)
16
Serious AEs
18.8%
Results posted
Jun 2024
Primary outcome: Primary: Tolerance (Time): Percent of Intended Treatment Hours That Patient Continues With the Delivery of Bright Light — 59; 61 percentage of intended treatment hours
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- standard light (Device); 10,000 lux bright light, 4 hours (Device); 10,000 lux bright light, 8 hours (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tolerance (Time): Percent of Intended Treatment Hours That Patient Continues With the Delivery of Bright Light |
59; 61 | — |
| SECONDARY Acceptance: Percent of Patients/Surrogates Who Agree to Bright Light When Initially Described |
59 | — |
| SECONDARY Tolerance (Symptoms): Percent of Patients Who Develop Eye Strain, Headache or Visual Disturbance. |
0; 2; 1 | — |
| SECONDARY Fidelity: Percent of Time Per Day That Device Delivers the Planned Dose of Light |
55; 55 | — |
| SECONDARY Sustainability: Percent of Intended Intervention Days That the Device is Used. |
94; 88 | — |
Summary
To evaluate the feasibility of providing daytime bright light in the ICU in a pilot randomized controlled trial.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03568045). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.