Hearing ImpairmentNCT05420038
Do Bluetooth Noise Cancelling Headphones Improve the Quality of Care in Hearing Impaired Patients?
An observational study of Hearing Impairment, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Impairment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2022to 19 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Adults; * Elderly; * University of Texas Medical Branch Ophthalmology and Optical clinic patients.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555
About this study
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.
Read more
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.
- Explore the ease of conducting refractive exam as reported by provider.
Read the 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.
- Explore the ease of conducting refractive exam as reported by provider.
- Conditions
- Hearing Impairment
- Keywords
- hearing impairment, geriatric, headphones, noise-cancelling, hearing assistance, ophthalmic, refractive exams, ophthalmology, limited hearing, impaired hearing, quality of exam, Sound-Check hearing test
- Medical subject headings
- Hearing Loss
What is being measured
The primary outcome is the main question the study is designed to answer.
Do Bluetooth Noise Cancelling Headphones Improve the Quality of Care in Hearing Impaired Patients?
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"
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start6 Jul 2022
- Primary completion19 Apr 2023
- Study completion19 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hearing ImpairmentStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Praveena K Gupta, PhD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420038
- Sponsor's protocol ID
- 22-0079
- Status last verified
- Jun 2023
- First submitted
- 10 Jun 2022
- Last updated
- 9 Jun 2023
- Results posted
- No
- Individual data sharing
- No
Publications
Chodosh J, Goldfeld K, Weinstein BE, Radcliffe K, Burlingame M, Dickson V, Grudzen C, Sherman S, Smilowitz J, Blustein J. The HEAR-VA Pilot Study: Hearing Assistance Provided to Older Adults in the Emergency Department. J Am Geriatr Soc. 2021 Apr;69(4):1071-1078. doi: 10.1111/jgs.17037. Epub 2021 Feb 11.
PubMed 33576037Sacco G, Gonfrier S, Teboul B, Gahide I, Prate F, Demory-Zory M, Turpin JM, Vuagnoux C, Genovese P, Schneider S, Guerin O, Guevara N. Clinical evaluation of an over-the-counter hearing aid (TEO First(R)) in elderly patients suffering of mild to moderate hearing loss. BMC Geriatr. 2016 Jul 9;16:136. doi: 10.1186/s12877-016-0304-4.
PubMed 27392722GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1211-1259. doi: 10.1016/S0140-6736(17)32154-2.
PubMed 28919117Bainbridge KE, Wallhagen MI. Hearing loss in an aging American population: extent, impact, and management. Annu Rev Public Health. 2014;35:139-52. doi: 10.1146/annurev-publhealth-032013-182510.
PubMed 24641557Nash SD, Cruickshanks KJ, Huang GH, Klein BE, Klein R, Nieto FJ, Tweed TS. Unmet hearing health care needs: the Beaver Dam offspring study. Am J Public Health. 2013 Jun;103(6):1134-9. doi: 10.2105/AJPH.2012.301031. Epub 2013 Apr 18.
PubMed 23597370Bentler R, Wu YH, Kettel J, Hurtig R. Digital noise reduction: outcomes from laboratory and field studies. Int J Audiol. 2008 Aug;47(8):447-60. doi: 10.1080/14992020802033091.
PubMed 18698521World Health Organization. Report of the informal working group on prevention of deafness and hearing impairment Programme planning, Geneva, 18-21 June 1991.
Glanzer BM, Ladki M, Chea MR, Hummel L, McKinnon B, Digbeu BDE, Merkley KH, Amin A, Gupta PK. Bluetooth Noise-Canceling Headphones Improve the Quality of Ophthalmic Exams in Patients With Hearing Loss: A Randomized Controlled Trial. Cureus. 2024 May 11;16(5):e60090. doi: 10.7759/cureus.60090. eCollection 2024 May.
PubMed 38860057
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Bluetooth Noise Cancelling Headphones Improve the Quality of Care in Hearing Impaired Patients?
- ClinicalTrials.gov ID
- NCT05420038
- Acronym / sponsor ID
- 22-0079
- Conditions
- Hearing Impairment
- Keywords
- hearing impairment, geriatric, headphones, noise-cancelling, hearing assistance, ophthalmic, refractive exams, ophthalmology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- 19 Apr 2023 (actual)
- Study completion
- 19 Apr 2023 (actual)
- First posted
- 15 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Explore the ease of conducting refractive exam as reported by provider.
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.
- Explore the ease of conducting refractive exam as reported by provider.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Adults; * Elderly; * University of Texas Medical Branch Ophthalmology and Optical clinic patients.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Background: PubMed 33576037Chodosh J, Goldfeld K, Weinstein BE, Radcliffe K, Burlingame M, Dickson V, Grudzen C, Sherman S, Smilowitz J, Blustein J. The HEAR-VA Pilot Study: Hearing Assistance Provided to Older Adults in the Emergency Department. J Am Geriatr Soc. 2021 Apr;69(4):1071-1078. doi: 10.1111/jgs.17037. Epub 2021 Feb 11.
- Background: PubMed 27392722Sacco G, Gonfrier S, Teboul B, Gahide I, Prate F, Demory-Zory M, Turpin JM, Vuagnoux C, Genovese P, Schneider S, Guerin O, Guevara N. Clinical evaluation of an over-the-counter hearing aid (TEO First(R)) in elderly patients suffering of mild to moderate hearing loss. BMC Geriatr. 2016 Jul 9;16:136. doi: 10.1186/s12877-016-0304-4.
- Background: PubMed 28919117GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1211-1259. doi: 10.1016/S0140-6736(17)32154-2.
- Background: PubMed 24641557Bainbridge KE, Wallhagen MI. Hearing loss in an aging American population: extent, impact, and management. Annu Rev Public Health. 2014;35:139-52. doi: 10.1146/annurev-publhealth-032013-182510.
- Background: PubMed 23597370Nash SD, Cruickshanks KJ, Huang GH, Klein BE, Klein R, Nieto FJ, Tweed TS. Unmet hearing health care needs: the Beaver Dam offspring study. Am J Public Health. 2013 Jun;103(6):1134-9. doi: 10.2105/AJPH.2012.301031. Epub 2013 Apr 18.
- Background: PubMed 18698521Bentler R, Wu YH, Kettel J, Hurtig R. Digital noise reduction: outcomes from laboratory and field studies. Int J Audiol. 2008 Aug;47(8):447-60. doi: 10.1080/14992020802033091.
- BackgroundWorld Health Organization. Report of the informal working group on prevention of deafness and hearing impairment Programme planning, Geneva, 18-21 June 1991.
- Derived from this study: PubMed 38860057Glanzer BM, Ladki M, Chea MR, Hummel L, McKinnon B, Digbeu BDE, Merkley KH, Amin A, Gupta PK. Bluetooth Noise-Canceling Headphones Improve the Quality of Ophthalmic Exams in Patients With Hearing Loss: A Randomized Controlled Trial. Cureus. 2024 May 11;16(5):e60090. doi: 10.7759/cureus.60090. eCollection 2024 May.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Praveena K Gupta, PhD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Impairment, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Do Bluetooth Noise Cancelling Headphones Improve the Quality of Care in Hearing Impaired Patients? (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05420038, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023.