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Behavioural Intervention

Daytime Bright Light for Delirium

N/A

Waitlist Available

Led By Melissa Knauert, MD, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Expected to stay in the Medical Intensive Care Unit (MICU) ≥24 hours after enrollment

Age ≥50 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up study day 2-30 (to study day 5 or micu discharge whichever is longer, patients will be censored at hospital discharge).

Awards & highlights

Study Summary

This trial will study if daytime bright light exposure can help reduce delirium symptoms.

Who is the study for?

This trial is for individuals aged 50 or older who are expected to stay in the Medical ICU for at least 24 hours after joining, and have been admitted to the hospital within the last 30 hours. It's not suitable for those with bipolar disease, paralysis, severe brain injuries, acute brain injuries, circadian disorders, blindness affecting optic nerves, or recent substance abuse.Check my eligibility

What is being tested?

The study is testing if using bright light during daytime can help align patients' body clocks and reduce or prevent delirium compared to usual lighting conditions. Patients will be exposed to different lighting while their sleep patterns and mental state are monitored.See study design

What are the potential side effects?

Potential side effects from exposure to bright light may include eye strain or discomfort and headaches. However, these effects are generally mild and temporary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I will be in the ICU for at least 24 hours after joining the study.

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I am 50 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study day 2-30 (to study day 5 or micu discharge whichever is longer, patients will be censored at hospital discharge).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~study day 2-30 (to study day 5 or micu discharge whichever is longer, patients will be censored at hospital discharge).

This trial's timeline: 3 weeks for screening, Varies for treatment, and study day 2-30 (to study day 5 or micu discharge whichever is longer, patients will be censored at hospital discharge). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Circadian Alignment

Days of Delirium

Secondary outcome measures

Circadian Alignment, Secondary Measures, Body surface temperature gradient

Heart rate

Circadian Alignment, Secondary Measures, urinary 6-sulfatoxymelatonin.

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Bright LightExperimental Treatment1 Intervention

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.

Group II: Usual LightActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Daytime Bright Light

2019

N/A

~70

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,851 Previous Clinical Trials

2,738,253 Total Patients Enrolled

Melissa Knauert, MD, PhDPrincipal InvestigatorYale University

2 Previous Clinical Trials

101 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What objective is this research project striving to accomplish?

"This study will examine the impact of light therapy on delirium over a 30 day period, with patients being censored at hospital discharge. Secondary objectives include assessing feasibility and intervention fidelity (percentage of time per day that device delivers the planned dose of light), as well as circadian alignment, patient tolerance (the amount of intended treatment hours continued once exposed to bright light) and urinary 6-sulfatoxymelatonin levels."

Answered by AI

Are there any openings left for potential participants in this experiment?

"Correct. Data on clinicaltrials.gov shows that the trial, first posted in July of 2019, is still recruiting patients and has been recently updated on July 22nd 2022. This study requires 120 individuals to be enrolled at single site."

Answered by AI

What is the current size of participation in this medical experiment?

"Affirmative. According to the information posted on clinicaltrials.gov, this medical study is still searching for participants since it was first made available on July 8th 2019 and last updated July 22nd 2022. Specifically, 120 individuals are needed to be recruited at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "Daytime Bright Light, Circadian Abnormalities, and Delirium in Medical ICU Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03684460.