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

Primary Purpose

Brain Concussion

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blue Light Glasses
Computer Reading Task
Sponsored by
Rochester Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Concussion

Eligibility Criteria

18 Years - 26 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rochester Institute of TechnologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Blue Light Glasses (experimental)

No Glasses (control)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 15, 2021
Last Updated
March 19, 2021
Sponsor
Rochester Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT04804501
Brief Title
Effect of Blue Light Glasses on Screen Usage After a Concussion in College Students
Official Title
Effect of Blue Light Glasses on Screen Usage After a Concussion in College Students
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rochester Institute of Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Concussion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blue Light Glasses (experimental)
Arm Type
Experimental
Arm Description
These subjects will wear the device (glasses) while performing a reading task.
Arm Title
No Glasses (control)
Arm Type
Other
Arm Description
These subjects will not wear the device (glasses) while performing a reading task.
Intervention Type
Device
Intervention Name(s)
Blue Light Glasses
Intervention Description
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
Other
Intervention Name(s)
Computer Reading Task
Intervention Description
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 Information:
Title
Time on Screen
Description
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.
Time Frame
30 minutes or less

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Rochester Institute of Technology
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zachary Bevilacqua, PhD, ATC
Phone
585-313-4608
Email
zwbihst@rit.edu

12. IPD Sharing Statement

Learn more about this trial

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

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