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

NCT ID: NCT04804501

Last Updated: 2021-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2022-12-31

Brief Summary

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.

Conditions

Brain Concussion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Blue Light Glasses (experimental)

These subjects will wear the device (glasses) while performing a reading task.

Group Type: EXPERIMENTAL

Blue Light Glasses

Intervention Type: DEVICE

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.

Computer Reading Task

Intervention Type: OTHER

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.

No Glasses (control)

These subjects will not wear the device (glasses) while performing a reading task.

Group Type: OTHER

Computer Reading Task

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rochester Institute of Technology

OTHER

Sponsor Role: lead

Responsible Party

Zachary Bevilacqua

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rochester Institute of Technology

Rochester, New York, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Zachary Bevilacqua, PhD, ATC

Role: primary

zwbihst@rit.edu

585-313-4608

Other Identifiers

RochesterIT

Identifier Type: -

Identifier Source: org_study_id