Recruiting

Blue Light Glasses

Sponsor:

Rochester Institute of Technology

Code:

NCT04804501

Conditions

Brain Concussion

Eligibility Criteria

Sex: All

Age: 18 - 26

Healthy Volunteers: Not accepted

Interventions

Blue Light Glasses

Computer Reading Task

Study Details

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 ID

NCT04804501

Start date

Mar 1, 2021

Status verified date

Mar, 2021

Completion date

Dec, 2022

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 26

Healthy Volunteers: Not accepted

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 Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Blue Light Glasses (experimental)

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

other: No Glasses (control)

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

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.

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.

Primary outcome measure

  • Time on Screen [ Time Frame: 30 minutes or less ]

Central Contacts and Locations

Locations

Rochester Institute of Technology

Recruiting

Rochester, New York, United States, 14623

Contacts

Zachary Bevilacqua, PhD, ATC

585-313-4608zwbihst@rit.edu

More Information

Sponsor

Rochester Institute of Technology

Last update posted

Mar 23, 2021

Last verified

Mar, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rochester Institute of Technology on 2021-03-23.