Hearing Aids Use in Elderly: Efficacy in Speech Perception and in Health-related Quality of Life

NCT04333043 | Completed DMC

• 1 other identifier: HA Elderly 2020
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Prevalence of hearing loss increases over age; its estimated prevalence is 40-50% in people older than 75 years. Recent studies agree that modification in the hearing threshold contributes to deterioration in sociality, sensitivity, cognition, and quality of life of the elderly subjects. Our study objective is to verify if rehabilitation with first time applied Hearing Aids (HA) in a cohort of old people with hearing impairment improves over time speech perception in a noisy environment and the overall health-related quality of life. Methods: The monocentric, prospective, repeated measures, single-subject, clinical observational study will accrue 100 elderly, first-time HA recipients (≥ 65 years). The evaluation protocol is designed to analyze changes on specific measurement tools a year after the first HA fitting in comparison to the evaluation before HA usage. Evaluations will consist of multiparametric details collected through self-report questionnaires completed by the recipients and a series of commonly used audiometric measures and geriatric assessment tools. The primary indicator of changes in speech perception in noise will be the OLSA test whereas the indicator of changes in overall quality of life will be the AQoL and HHEI questionnaires. Montreal Cognitive Assessment (MoCA) will help us to verify the cognitive state of the subjects. This questionnaire will allow us to exclude a reduction of the cognitive abilities over time. Discussion: The protocol is designed to make use of measurement tools that have already been applied to the hearing-impaired population in order to compare the effects of HA rehabilitation in the elderly immediately before their first HA usage (Pre) and after gaining 1 year of experience (Post). The broad approach will lead to a greater understanding of how useful hearing influences the quality of life in elderly individuals, and thus improves potentials for healthy aging. Outcomes will be described and analyzed in detail.

Conditions

Hearing Loss, Age-Related

Outcome Measures

Primary Outcomes (2)

• Improvement in speech recognition in noise with audiometrical test

  The primary aim is to identify significant improvement in speech recognition in noise in elderly patients (\>= 65 years) that use Hearing Aids for the first time. To verify this aim, our patients are subject to audiometric tests in quiet conditions. Audiometric test include standard threshold measures for frequencies 250-4000 Hz (pure tone audiogram) and speech discrimination (speech audiometry). Normal hearing patients show an average threshold less than 30 dB in the pure tone audiogram. Speech audiometry shows the Speech Reception Threshold (SRT), defined as the level of speech corresponding to 50% of correct answers. Normal hearing patients show a SRT at 30 dB.

  up to 12 months

• Improvement in speech recognition in noise with OLSA test

  The primary aim is to identify significant improvement in speech recognition in noise in elderly patients (\>= 65 years) that use Hearing Aids for the first time. The primary aim is to identify significant improvement in speech recognition in noise in elderly patients (\>= 65 years) that use Hearing Aids for the first time. To verify this aim, our patients are subject to audiometric tests in noise condition. The audiometric test in noise condition is a speech adaptive audiometry: Italian version of Oldenburg Satztest (OLSA test). The test is conducted using a closed-set response format. Puglisi et al. (2015) described the reference ranges and standard deviations of the OLSA test for the Italian language. The cutoff of the SNR dB (SRT) among the elderly was set to - 0.4 dB based on a reference mean level of -6.7 plus 2 standard deviations. Lower scores underlines a better performances.

  up to 12 months

Secondary Outcomes (4)

• Hearing Aids and quality of life with AQoL-8D questionnaire

  up to 12 months

• Hearing Aids and cognitive skills with MOCA questionnaire

  up to 12 months

• Hearing Aids and cognitive skills and quality of life with IOI-HA questionnaire

  up to 12 months

• Hearing Aids and cognitive skills with HHIE-S questionnaire

  up to 12 months

Study Arms (1)

Hearing Aids

Hearing Aids use

Diagnostic Test: audiological test, cognitive questionnaires

Interventions

audiological test, cognitive questionnaires DIAGNOSTIC_TEST

administration of cognitive and quality of life questionnaires and audiological test

Hearing Aids

Eligibility Criteria

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

Study Population

Study subjects who use for the first time unilateral or bilateral hearing aids will be included. Eligible participants are consecutively identified on the HA registry of the Local Unit of the National Health System (NHS). Italian NHS is a welfare system which funds totally or partially the HA costs in selected patients. Subjects are \> = 65 years old people using unilateral or bilateral HA for the first time. According to local NHS threshold-criteria for funding adult's HAs, patients' best ear must have a Pure-Tone Average \>= 45 dB HL. Subjects are enrolled in the clinical investigation only after signing the Patient Informed Consent Form prior to the first assessment (baseline, t0). An approximate number of 100 individuals will be included.

You may qualify if:

• Age \>= 65 years
• First use of unilateral or bilateral HA
• HA partially or totally funded by the National Health System
• Willingness to participate in and to comply with all study procedures
• Fluency in languages used to assess clinical performance
• Able to decide on study participation personally, and independently sign their consent

You may not qualify if:

• Unilateral hearing loss
• Previous use of HA
• Significantly/severely dependent or fragile
• Unable to provide consent personally
• Unable to complete questionnaires for self-assessment independently
• Significant comorbidities preventing study participation (e.g. blindness, immobility or in a wheelchair, severe aphasia, and other)
• Unrealistic expectations on the part of the subject regarding the possible benefits, risks and limitations inherent to the procedure and prosthetic device.

Sponsors & Collaborators

• Azienda Unita Sanitaria Locale di Piacenza: lead

Study Sites (1)

Ospedale Guglielmo da Saliceto- ENT Department

Piacenza, PC, 29121, Italy

Location

Related Publications (2)

• Ghiselli S, Soncini A, Fabrizi E, Salsi D, Cuda D. Factors correlated with hearing aids adherence in older adults: a prospective controlled study. J Int Med Res. 2024 Jun;52(6):3000605241232549. doi: 10.1177/03000605241232549.

  PMID: 38861681 DERIVED

• Cuda D, Ghiselli S, Murri A. Evaluation of the efficacy of hearing aids in older adults: a multiparametric longitudinal study protocol. BMC Geriatr. 2021 Feb 5;21(1):107. doi: 10.1186/s12877-021-02033-z.

  PMID: 33581722 DERIVED

MeSH Terms

Conditions

Presbycusis

Condition Hierarchy (Ancestors)

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

Study Officials

• Domenico Cuda, MD

  Ospedale Guglielmo da Saliceto, Piacenza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, MD, Head of Otolaryngology, PhD student

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: April 3, 2020
• Study Start: February 7, 2018
• Primary Completion: December 31, 2023
• Study Completion: January 1, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-07

Locations

IT (1)