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

NCT05420038 | Completed

• 1 other identifier: 22-0079
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• 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"

  8 months

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Related Publications (8)

• 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.

  PMID: 33576037 BACKGROUND

• Sacco 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.

  PMID: 27392722 BACKGROUND

• GBD 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.

  PMID: 28919117 BACKGROUND

• Bainbridge 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.

  PMID: 24641557 BACKGROUND

• Nash 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.

  PMID: 23597370 BACKGROUND

• Bentler 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.

  PMID: 18698521 BACKGROUND

• World Health Organization. Report of the informal working group on prevention of deafness and hearing impairment Programme planning, Geneva, 18-21 June 1991.

  BACKGROUND

• 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.

  PMID: 38860057 DERIVED

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Praveena K Gupta, PhD

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 15, 2022
• Study Start: July 6, 2022
• Primary Completion: April 19, 2023
• Study Completion: April 19, 2023
• Last Updated: June 9, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)