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

March 19, 2021 updated by: Zachary Bevilacqua, Rochester Institute of Technology
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 22 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time on Screen
Time Frame: 30 minutes or less
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rochester Institute of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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