Effect of Blue Light Glasses on Screen Usage After a Concussion in College Students

Premature cessation of screen usage is a common behavior post-concussion, given the taxing nature of a screen-time task. In the academic setting, screen-time is a near unavoidable component, however, complete avoidance of class and screen use may in fact provoke psychological symptoms of anxiety and depression in students, for fear of falling behind in their studies. Thus, compensatory measures should be investigated to assist students as they attempt to maintain academic involvement throughout their concussion recovery. Blue light blocking glasses have been shown to significantly increase screen-time usage in individuals with post-concussion syndrome, yet these results are only representative of a small portion of the concussion population. Thus, we propose investigating whether blue light blocking glasses can prolong screen usage prior to symptom exacerbation, specifically in concussed students that are still within the normal recovery timeframe. This cross-sectional randomized clinical trial will provide further evidence of the utility blue light blocking glasses can offer as a therapeutic tool for students recovering from concussion. We would like to test volunteers from the Rochester Institute of Technology who have been treated by a medical provider within the university's health center. Blue light glasses will be worn during a one-time computer reading task while the subject is participating in the study. The total time for the complete the reading task is dependent upon the participant's symptom fluctuations; however, we suspect completion criteria will be met within 20 minutes from beginning. The risks in this study are minimal and results may increase our understanding of therapeutic tools for patients with ocular-driven concussion symptoms.

Study Overview

• Status: Recruiting
• Conditions: Brain Concussion
• Intervention / Treatment: Device: Blue Light Glasses; Other: Computer Reading Task

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14623
      • Recruiting
      • Rochester Institute of Technology
      • Contact: Zachary Bevilacqua, PhD, ATC; Phone Number: 585-313-4608; Email: zwbihst@rit.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 24 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Full-time student at RIT
• Diagnosed mild traumatic brain injury
• Between 18-26 years of age
• Within 3-14 days post-injury

Exclusion Criteria:

• Any head, neck, or face injury in the 1 year prior to the study (e.g., concussion, eye injury) other than the current injury
• History of vestibular or ocular dysfunction\
• Any neurological disorders (e.g., seizure disorders, closed head injuries with loss of consciousness greater than 15 minutes, CNS neoplasm, history of stroke)
• Injury more severe than mild traumatic brain injury (skull fracture, positive CT or MRI)
• Having taken pain medication within 8 hours prior to testing
• Not able to personally consent
• Pregnant
• Deaf or hard of hearing.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blue Light Glasses (experimental); These subjects will wear the device (glasses) while performing a reading task.	Device: Blue Light Glasses; Participants will be randomized into an experimental group (blue light glasses) or a control group (no glasses). Participants will perform a computer reading task while either wearing, or not wearing the glasses.; Other: Computer Reading Task; Participants will read on a computer until concussion symptoms increase by a score of 3 or more (reading task termination criteria). One or more points will be assigned for each increase in symptom severity, and one point will be assigned for each new symptom that appears.
Other: No Glasses (control); These subjects will not wear the device (glasses) while performing a reading task.	Other: Computer Reading Task; Participants will read on a computer until concussion symptoms increase by a score of 3 or more (reading task termination criteria). One or more points will be assigned for each increase in symptom severity, and one point will be assigned for each new symptom that appears.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time on Screen	The amount of time a participant can spend on time, prior to meeting termination criteria, will be recorded and compared between experimental and control groups.	30 minutes or less

Collaborators and Investigators

• Sponsor: Rochester Institute of Technology

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: March 15, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 19, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: RochesterIT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes