Do Bluetooth Noise Cancelling Headphones Improve the Quality of Care in Hearing Impaired Patients?

June 7, 2023 updated by: The University of Texas Medical Branch, Galveston

Participants will be recruited by performing chart reviews of patients to be seen at University of Texas Medical Branch at Galveston Ophthalmology and Optometry Clinic. A sample size of at least 30 patients is needed (60 eyes). Patients aged 55 and higher will be further evaluated to meet the inclusion criteria. Patients meeting inclusion criteria will be provided with informed consent to participate in the study before their office visit. Patients will receive a consent briefing then asked to sign and date the informed consent form. Participants will then be randomized to undergo an eye exam and refractive exam with noise cancelling Bluetooth headphones for one eye and without for the other eye. Participants will fill out a written survey asking them to rate the quality of the eye exam with and without headphones.

Primary aim: Assess the quality improvement of Ophthalmic exam in geriatric patients with hearing loss with use of noise cancelling headphones with Bluetooth feature.

Secondary aims: 1)Compare the response to the standardized questions with and without Bluetooth noise cancelling headphones to determine their effectiveness in conducting Ophthalmic refractive exam.

2) Explore the ease of conducting refractive exam as reported by provider.

Study Overview

Status

Completed

Conditions

Detailed Description

Initial screening in this study will be conducted by performing chart reviews of the patients to be seen at University of Texas Medical Branch ophthalmology and optometry clinics between dates 05/09/2022 and 12/15/2022. Potential subjects will be provided with details about the study through debriefing about the informed consent before the start of their visit at University of Texas Medical Branch clinics. An option to participate in the study will be provided for recruitment by the principal investigator and the co-investigators. If potential subjects are not patients of the investigator or patients of the study team members, they will not be contacted by study staff unless they have been informed of the study by their medical provider and expressed an interest in receiving more information on the study or wish to enroll in the study. A sample size of at least 30 patients is needed (60 eyes). Patients aged 55 and higher will be further evaluated to meet the inclusion criteria. Patients meeting inclusion criteria will be provided with informed consent to participate in the study before their office visit. Patients will receive a consent briefing from the principal investigator or the co-investigators regarding the purpose of the study, number of people taking part in the study, procedures involved in the study, possible risks, potential benefits, reimbursement, alternative treatment, consent to leave study at any time, protection of patient information and privacy, and contact information for questions regarding the study. They will then be asked to sign and date the informed consent form. The signed consent forms will be stored in a locked file cabinet in room 3.420C of the University of Texas Medical Branch University Eye Clinic building. Patients who consent to participate in this study will then be randomized to undergo an eye exam and refractive exam with noise cancelling Bluetooth headphones for one eye and without for the other eye. The order in which the headphones are used will also be randomized by flipping a coin. Lastly, patients will fill out a written survey with a 3-point Likert scale with the following question:

How do you rate the quality of your eye exam today with headphones as compared to without headphones? 1) Better 2) No difference 3) Worse Primary aim: Assess the quality improvement of Ophthalmic exam in geriatric patients with hearing loss with use of noise cancelling headphones with Bluetooth feature.

Secondary aims: 1) Compare the response to the standardized questions with and without Bluetooth noise cancelling headphones to determine their effectiveness in conducting Ophthalmic refractive exam.

2) Explore the ease of conducting refractive exam as reported by provider.

Study Type

Observational

Enrollment (Actual)

30

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
    • Texas
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch

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

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

  • Adults;
  • Elderly;
  • University of Texas Medical Branch Ophthalmology and Optical clinic patients.

Description

Inclusion Criteria:

  • Participants are patients of University of Texas Medical Branch Ophthalmology and Optical clinics;
  • patients of investigators;
  • aged 55 years and above;
  • participants with moderate hearing impairment or worse at baseline hearing grade of limited or impaired based on World Health Organization (WHO) hearing loss guidelines;
  • participants with documented history of hearing loss;
  • participants with no corrective procedures performed for hearing loss.

Exclusion Criteria:

  • Participants with mild to no hearing impairment at baseline reported as hearing grade fair, good or excellent on the Sound-Check hearing test;
  • participants with history of corrective procedure performed for hearing loss;
  • participants with cognitive impairment;
  • participants with visual impairment of best corrected visual acuity (BCVA) 20/100 or worse in either eye or patients with monocular vision;
  • participants from vulnerable populations, such as prisoners.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Do Bluetooth Noise Cancelling Headphones Improve the Quality of Care in Hearing Impaired Patients?
Time Frame: 8 months
Patients will fill out a written survey with a 3-point Likert scale with the following question: "How do you rate the quality of your eye exam today with headphones as compared to without headphone? 1) Better 2) No difference 3) Worse"
8 months

Collaborators and Investigators

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

Sponsor

The University of Texas Medical Branch, Galveston

Investigators

  • Principal Investigator: Praveena K Gupta, PhD, University of Texas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 6, 2022

Primary Completion (Actual)

April 19, 2023

Study Completion (Actual)

April 19, 2023

Study Registration Dates

First Submitted

June 10, 2022

First Submitted That Met QC Criteria

June 10, 2022

First Posted (Actual)

June 15, 2022

Study Record Updates

Last Update Posted (Actual)

June 9, 2023

Last Update Submitted That Met QC Criteria

June 7, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-0079

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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