Hearing Loss, Age-RelatedNCT04333043
Hearing Aids Use in Elderly: Efficacy in Speech Perception and in Health-related Quality of Life
An observational study of Hearing Loss, Age-Related, run by Azienda Unita Sanitaria Locale di Piacenza at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Age-Related
- What is being tested?
- audiological test, cognitive questionnaires
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 7 Feb 2018to 1 Jan 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Hearing Aids Efficacy in Elderly Subjects: a Protocol for Multiparametric Longitudinal Study
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.
Read more
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.
Read the detailed description
This study wants to identify significant improvement in speech recognition in noise in elderly patients (>= 65 years) that use HA for the first time and the correlations between the use of the HA and quality of life and cognitive status in elderly patients.
This is a repeated measure, single-subject, prospective observational study. No additional intervention is applied to population of HA recipients. 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.
An approximate number of 100 individuals will be included. The study design is monocentric and it is conducted at the outpatient service of the ENT Department of the "Saliceto" Hospital.
The test includes language-appropriate materials relative to the participating HA recipient.
The evaluation protocol is designed to coincide with routine clinical visits. Each subject is assessed with the full test-battery and questionnaires that are repeated at each of the two visits: one before the HA fitting (Pre) and one after one year of HA use (Post).
Subjects are enrolled in the clinical investigation only after signing the Patient Informed Consent Form prior to the first assessment (baseline, t0).
During the first assessment (Pre) are carried out this procedures: otoscopy and cleaning of the external auditory canal,- unaided pure tone audiometry, unaided speech audiometry in quiet, Italian version of Oldenburg Satztest (OLSA test) and Montreal Cognitive Assessment (MOCA), Hearing Handicap Inventory in the Elderly Screening test (HHIE-S) and Assessment of Quality of Life (AQoL) questionnaires.
During the second assessment (Post) are carried out: otoscopy and cleaning of the external auditory canal, test of the HA functioning, unaided pure tone audiometry, aided speech audiometry in quiet, Italian version of OLSA test and MOCA, HHIE-S, AQoL and International Outcome Inventory for Hearing Aids (IOI-HA) questionnaires.
The maximum administration time for completion of all measures is estimated to be approximately one hour of which 30 minutes are dedicated to standard self-report forms completed by the HA recipient.
In addition to general healthcare and patient-profile data, a selection of observational clinical assessment tools has been chosen for repeated evaluations to reflect changes in the hearing aid benefit and the overall health status of the elderly individual at post-HA use. These tools are commonly used in audiology and/or geriatric practices and are administered in the appropriate language. All questionnaires are validated for the Italian language.
- Conditions
- Hearing Loss, Age-Related
- Being tested
- audiological test, cognitive questionnaires
- Medical subject headings
- Presbycusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
audiological test, cognitive questionnairesDiagnostic test
administration of cognitive and quality of life questionnaires and audiological test
| Study group | Role | What they receive |
|---|---|---|
| Hearing Aids | Hearing Aids use Receives: Diagnostic Test: audiological test, cognitive questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 12 months
Secondary outcomes (4)
Hearing Aids and quality of life with AQoL-8D questionnaire
The secondary aim is to process the correlations between the use of the HA and quality of life in elderly.
To verify this aim, our patients are subject to this questionnaire: Assessment of Quality of Life (AQoL).
The AQoL-8D consists of five psychosocial and three physical dimension. The AQoL includes 35 items with 5 possible answers; this questionnaire does not have a score scale.
Measured: up to 12 months
Hearing Aids and cognitive skills with MOCA questionnaire
The secondary aim is to process the correlations between the use of the HA and cognitive status in elderly.
To verify this aim, our patients are subject to this questionnaire: Montreal Cognitive Assessment (MoCA).
MoCA detects cognitive impairment. It consisting of 12 subtasks. The total score ranges from 0 (worst performance) to 30 (best performance). The presence of mild cognitive dysfunction is suspected when the final score is less than 26.
Measured: up to 12 months
Hearing Aids and cognitive skills and quality of life with IOI-HA questionnaire
The secondary aim is to process the correlations between the use of the HA and quality of life and cognitive status in elderly.
To verify this aim, our patients are subject to this questionnaire: International Outcome Inventory for Hearing Aids (IOI-HA).
IOI-HA quantifies the satisfaction of hearing aid users. The IOI-HA contains seven domains used to subjectively evaluate the results of the HA under the following parameters: (1) time for which HA have been used; (2) benefit; (3) residual limitation in daily life activities; (4) satisfaction; (5) residual restrictions to participation; (6) impact on other people; and (7) quality of life.
The answers to each question range from poor performance (1) to best performance (5).
A high score is an indication of good outcome in aided conditions.
Measured: up to 12 months
Hearing Aids and cognitive skills with HHIE-S questionnaire
The secondary aim is to process the correlations between the use of the HA and cognitive status in elderly.
To verify this aim, our patients are subject to this questionnaire: Hearing Handicap Inventory for the Elderly Screening Version (HHIE-S).
HHIE-S assess the effects of hearing impairment on emotional and social adjustment in everyday life.
This test contains a 10-item questionnaire. The answers to each question range from poor performance (0) to best performance (4). A low HHIE-S total score indicates less perceived difficulties.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start7 Feb 2018
- Primary completion31 Dec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, Age-RelatedStudies of the same condition, open and under way.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Unita Sanitaria Locale di Piacenza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Ghiselli, Azienda Unita Sanitaria Locale di Piacenza
- Investigators
- Domenico Cuda, MD, Principal investigator, Ospedale Guglielmo da Saliceto, Piacenza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333043
- Sponsor's protocol ID
- HA Elderly 2020
- Status last verified
- Jul 2024
- First submitted
- 26 Mar 2020
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38861681Cuda 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.
PubMed 33581722
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Hearing Aids Efficacy in Elderly Subjects: a Protocol for Multiparametric Longitudinal Study
- ClinicalTrials.gov ID
- NCT04333043
- Acronym / sponsor ID
- HA Elderly 2020
- Conditions
- Hearing Loss, Age-Related
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Azienda Unita Sanitaria Locale di PiacenzaUniversity, hospital or other
- Study start
- 7 Feb 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 3 Apr 2020 (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.
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.
Detailed description
This study wants to identify significant improvement in speech recognition in noise in elderly patients (>= 65 years) that use HA for the first time and the correlations between the use of the HA and quality of life and cognitive status in elderly patients.
This is a repeated measure, single-subject, prospective observational study. No additional intervention is applied to population of HA recipients. 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.
An approximate number of 100 individuals will be included. The study design is monocentric and it is conducted at the outpatient service of the ENT Department of the "Saliceto" Hospital.
The test includes language-appropriate materials relative to the participating HA recipient.
The evaluation protocol is designed to coincide with routine clinical visits. Each subject is assessed with the full test-battery and questionnaires that are repeated at each of the two visits: one before the HA fitting (Pre) and one after one year of HA use (Post).
Subjects are enrolled in the clinical investigation only after signing the Patient Informed Consent Form prior to the first assessment (baseline, t0).
During the first assessment (Pre) are carried out this procedures: otoscopy and cleaning of the external auditory canal,- unaided pure tone audiometry, unaided speech audiometry in quiet, Italian version of Oldenburg Satztest (OLSA test) and Montreal Cognitive Assessment (MOCA), Hearing Handicap Inventory in the Elderly Screening test (HHIE-S) and Assessment of Quality of Life (AQoL) questionnaires.
During the second assessment (Post) are carried out: otoscopy and cleaning of the external auditory canal, test of the HA functioning, unaided pure tone audiometry, aided speech audiometry in quiet, Italian version of OLSA test and MOCA, HHIE-S, AQoL and International Outcome Inventory for Hearing Aids (IOI-HA) questionnaires.
The maximum administration time for completion of all measures is estimated to be approximately one hour of which 30 minutes are dedicated to standard self-report forms completed by the HA recipient.
In addition to general healthcare and patient-profile data, a selection of observational clinical assessment tools has been chosen for repeated evaluations to reflect changes in the hearing aid benefit and the overall health status of the elderly individual at post-HA use. These tools are commonly used in audiology and/or geriatric practices and are administered in the appropriate language. All questionnaires are validated for the Italian language.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hearing Aids | – | Diagnostic Test: audiological test, cognitive questionnairesHearing Aids use |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| audiological test, cognitive questionnairesadministration of cognitive and quality of life questionnaires and audiological test | Diagnostic test | Hearing Aids |
Primary outcome
Improvement in speech recognition in noise with audiometrical test
Time frame: up to 12 months
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.
Improvement in speech recognition in noise with OLSA test
Time frame: up to 12 months
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.
4 secondary outcomes
Hearing Aids and quality of life with AQoL-8D questionnaire
Time frame: up to 12 months
Hearing Aids and cognitive skills with MOCA questionnaire
Time frame: up to 12 months
Hearing Aids and cognitive skills and quality of life with IOI-HA questionnaire
Time frame: up to 12 months
Hearing Aids and cognitive skills with HHIE-S questionnaire
Time frame: up to 12 months
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 1 Aug 2024.
- Derived from this study: PubMed 38861681Ghiselli 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.
- Derived from this study: PubMed 33581722Cuda 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.
- Individual participant dataSharing planned: Undecided
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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.
Domenico Cuda, MD principal investigator
Ospedale Guglielmo da Saliceto, Piacenza
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 Loss, Age-Related, run by Azienda Unita Sanitaria Locale di Piacenza at 1 site in Italy.
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 7 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 1 Aug 2024. 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 Italy. 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?
Improvement in speech recognition in noise with audiometrical test (time frame: up to 12 months). The study lists 2 primary outcomes in all. 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 NCT04333043, which also lists 2 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 1 Aug 2024.