Effects of Blocking Blue Light at Night Post CABG, AVR, MVR, CABG AVR, CABG MVR, or SAH

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-75
SponsorWest Virginia University

About this trial

Purpose The purpose of this study is to determine whether filtering out blue light at nighttime reduces post-surgical inflammation and/or moderates cognitive decline and mood and sleep alterations in patients undergoing elective CABG, AVR, MVR, CABG AVR, CABG MVR, or SAH surgery. If manipulating nighttime light in hospital rooms improves patient outcomes, then it would be a relatively easy and inexpensive innovation that could reduce post-surgical complications and save millions of dollars per year in health care costs by shortening the length of hospital stays and reducing morbidity. The investigators aim to determine the relationship between inflammation and cognitive dysfunction after cardiac surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Both men and women that are undergoing elective (non-emergency)

on-pump CABG surgery,

AVR,

MVR,

Disqualifiers

Evidence or diagnosis of dementia or other cognitive deficit

Diagnosed psychiatric disorder (including depression and anxiety)

Organ failure [kidney (creatine > 1.5 mg/dL), liver, etc.]

Chronic obstructive pulmonary disease,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Blue light-blocking goggles

    Other intervention

    Participants will be randomly assigned to one of the two intervention groups.

  • Clear goggles

    Other intervention

    Participants will be randomly assigned to one of the two intervention groups.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Clear gogglesPlacebo comparator 1 intervention
Group B: Blue-light blocking gogglesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in baseline serum cytokine profile

Assessed via an immuno multiplex panel for the following cytokines:TNF-α, IL-1β, IL-6, IL-2, and IL-8. Units of measure for all cytokines are pg/mL.

Time frame
5 days post-surgery
2

Change in baseline serum cytokine profile

Assessed via an immuno multiplex panel for the following cytokines:TNF-α, IL-1β, IL-6, IL-2, and IL-8. Units of measure for all cytokines are pg/mL.

Time frame
30 days post-surgery
3

Change in baseline serum cardiac ischemia profile

Assessed via an immuno multiplex panel for the following indicators of ischemia: CRP, BNP, NT-proBNP, cardiac troponin T, and CK-MB. Units of measure for all indicators of ischemia are pg/mL.

Time frame
5 days post-surgery
4

Change in baseline serum cardiac ischemia profile

Assessed via an immuno multiplex panel for the following indicators of ischemia: CRP, BNP, NT-proBNP, cardiac troponin T, and CK-MB. Units of measure for all indicators of ischemia are pg/mL.

Time frame
30 days post-surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

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