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

NCT04804501 | Unknown FDA Device

• 1 other identifier: RochesterIT
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Blue Light Glasses (experimental)

EXPERIMENTAL

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

Device: Blue Light Glasses; Other: Computer Reading Task

No Glasses (control)

OTHER

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

Other: Computer Reading Task

Interventions

Blue Light Glasses 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.

Blue Light Glasses (experimental)

Computer Reading Task 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.

Blue Light Glasses (experimental); No Glasses (control)

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rochester Institute of Technology: lead

Study Sites (1)

Rochester Institute of Technology

Rochester, New York, 14623, United States

RECRUITING

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 18, 2021
• Study Start: March 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 23, 2021

Record last verified: 2021-03

Locations

US (1)