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

Brain Concussion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04804501
• Other study ID #: RochesterIT
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: December 2022

Study information

• Verified date: March 2021
• Source: Rochester Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 26 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Concussion

Intervention

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.

Locations

Country	Name	City	State
United States	Rochester Institute of Technology	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Rochester Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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