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Behavioural Intervention

Bright Light Therapy for Circadian Rhythm Sleep Disorder

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

Age ≥50 years

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up study day 2-5

Awards & highlights

Study Summary

This trial will test whether providing bright light during the day to ICU patients is feasible and has potential benefits.

Who is the study for?

This trial is for English-speaking individuals over 50 years old, admitted to the ICU within the last 30 hours and expected to stay at least another day. They must have a history of hypertension but no severe or recent brain injuries, circadian disorders, blindness, bipolar disease, paralysis, hepatic encephalopathy due to liver disease, homelessness, shift work in the past year or substance abuse including alcohol.Check my eligibility

What is being tested?

The study tests if bright light (10,000 lux) exposure for either 4 or 8 hours during daytime can help with sleep-related issues in ICU patients compared to standard lighting. It's a pilot randomized controlled trial aimed at assessing this intervention's feasibility.See study design

What are the potential side effects?

While not explicitly stated here, potential side effects from bright light therapy may include eyestrain, headache, irritability and difficulty sleeping. These 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 am 50 years old or older.

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

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I have a history of high blood pressure and take medication for it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study day 2-5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~study day 2-5

This trial's timeline: 3 weeks for screening, Varies for treatment, and study day 2-5 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Tolerance (time): Percent of intended treatment hours that patient continues with the delivery of bright light

Secondary outcome measures

Acceptance: Percent of patients/surrogates who agree to bright light when initially described

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

Sustainability: Percent of intended intervention days that the device is used.

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: 10,000 lux bright light, 8 hoursExperimental Treatment1 Intervention

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.

Group II: 10,000 lux bright light, 4 hoursExperimental Treatment1 Intervention

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.

Group III: Usual care, standard lightActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

10,000 lux bright light, 8 hours

2018

N/A

~20

10,000 lux bright light, 4 hours

2018

N/A

~20

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,847 Previous Clinical Trials

2,737,652 Total Patients Enrolled

Melissa Knauert, MD, PhDPrincipal InvestigatorYale University

2 Previous Clinical Trials

153 Total Patients Enrolled

Media Library

Circadian Rhythm Sleep Disorder Research Study Groups: 10,000 lux bright light, 4 hours, 10,000 lux bright light, 8 hours, Usual care, standard light

Frequently Asked Questions

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

Are there still opportunities for enrolment in this experiment?

"Evidence found on clinicaltrials.gov reveals that this trial, which was originally published on December 3rd 2018, is not actively recruiting at the moment. However, there are 181 other medical studies with open enrollment for patients who may be interested in participating."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feasibility Pilot of Bright Light in the Intensive Care Unit

2018. "Feasibility Pilot of Bright Light in the Intensive Care Unit". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03568045.