Listening EffortNCT05781126
The Effect of Listening Effort, Cognition and Anxiety-depression in Listening Satisfaction by Hearing Aid Users
An observational study of Listening Effort and Cognitive Function 1, Social, run by Chania General Hospital "St. George".
Trial summary
Brief Summary Introduction: Listening can be effortful in situations that require the intensive use of cognitive processing resources especially for individuals with a hearing loss. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Listening Effort, Cognitive Function 1, Social, Anxiety
- What is being tested?
- The Spatial Hearing Questionnaire, MINI-MENTAL STATE EXAMINATION, International Outcome Inventory - Hearing Aid, Glasgow Hearing Aid Benefit Profile, BECK-II and STAI questionnaires
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2023to 15 Dec 2023
- How long will I take part?
- 1 Day
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited from the outpatient ENT clinic of Chania General Hospital.
Who may be able to join
- participants aged between 18 and 80 years
- with sensorineural or mixed bilateral hearing loss
- wearing a hearing aid, unilaterally or bilaterally for at least 6 months
- all participants should give a written consent for their participation and the permission for the anonymously use of their results.
Who cannot join
- known neurological disease e.g. neurodegenerative disease (including disease Alzheimer's or dementia), demyelinating disease, metastatic disease
- known psychiatric illness
- illiteracy or non-use of the Greek language
- non-consent to participate in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Listening Effort, Cognition Status, and Anxiety or Depression in Listening Satisfaction by Hearing Aid Users
Brief Summary Introduction: Listening can be effortful in situations that require the intensive use of cognitive processing resources especially for individuals with a hearing loss. Hearing-impaired listeners are under a greater degree of cognitive challenge during a hearing task, speech comprehension, memory, response in an auditory message. Listening effort is defined as 'the attention and cognitive resources required to understand speech'. Hearing ability is the strongest predictor of speech understanding accuracy, but cognitive factors, psychological state of the listener and stress also play a significant role. Although there is no gold-standard method for listening effort assessment. a wide range of techniques is used such as: a) self-report methods, b) behavioral measures, or c) physiological measures. Cognitive functioning refers to multiple mental abilities, including receiving visual and auditory message, decision making, processing information and memory skills. During the ageing process there is a decline in cognitive function. The most common tools to measure it are: a) Montreal Cognitive Assessment (MoCA) test b) Mini-Mental State Exam (MMSE), and c) το Mini Cog. Within the older adult population with hearing loss, prevalence estimates that up to 20% report a clinically relevant level of depression symptoms that would necessitate treatment. A cross-sectional association between hearing loss and depression among older adults has been consistently observed. A reduction in activities of daily living observed in older adults with hearing loss, suggesting that disengagement in activities post-hearing loss may contribute to depression. The satisfaction due to amplification for the hearing aid- user is effected by the changes in his everyday routine and also depend on the level of his cognitive function, motivation, psychological status and social environment. Purpose: The purpose of this study is to investigate the effect of listening effort, cognitive function, stress and depression on amplification satisfaction for adult hearing aid-users. Methods and materials: This is a prospective study including patients examined in the outpatient department of ENT clinic in General Hospital of Chania. Patients fulfilling the inclusion criteria will undergo: a) medical history record, b) ENT examination, c) pure tone audiogram and speech audiometry (with and without the hearing amplification) d) listening effort evaluation (with and without the hearing amplification) Self-report and behavioral methods will be used: Evaluation of subjective performance (Spatial Hearing Questionnaire (SHQ) Evaluation of time response in auditory message Evaluation of speech comprehension with background noise or a competitive speaker e) cognitive function evaluation by using the Greek version of Mini-Mental State Examination, f) evaluation of hearing-aid satisfaction, by using the Glasgow Hearing Aid Benefit Profile (GHABP), and International Outcome Inventory - Hearing Aid (IOI-HA), questionnaires and g) evaluation of stress level and depression by using BECK-II and STAI questionnaires. Results: The main outcome will be the assessment of listening effort, cognitive function, psychological status (stress/depression) effect on the level of satisfaction of hearing-aid users. Additional outcomes will be the assessment of the effect of cognitive decline in listening effort and the effect of psychological status on listening effort. Study findings will highlight the potential of changing the approach and management of the hearing aid-users in a way that hearing amplification will lead to satisfaction of their expectations
- Conditions
- Listening Effort, Cognitive Function 1, Social, Anxiety, Depression, Satisfaction, Consumer, Amplification
- Being tested
- The Spatial Hearing Questionnaire, MINI-MENTAL STATE EXAMINATION, International Outcome Inventory - Hearing Aid, Glasgow Hearing Aid Benefit Profile, BECK-II and STAI questionnaires
- Medical subject headings
- Anxiety Disorders, Depression, Consumer Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Spatial Hearing Questionnaire, MINI-MENTAL STATE EXAMINATION, International Outcome Inventory - Hearing Aid, Glasgow Hearing Aid Benefit Profile, BECK-II and STAI questionnairesDiagnostic test
- medical history record, b) ENT examination, c) pure tone audiogram and speech audiometry (with and without the hearing amplification) d) listening effort evaluation (with and without the hearing amplification) Self-report and behavioral methods will be used: Evaluation of subjective performance (Spatial Hearing Questionnaire (SHQ) Evaluation of time response in auditory message Evaluation of speech comprehension with background noise or a competitive speaker e) cognitive function evaluation by using the Greek version of Mini-Mental State Examination, f) evaluation of hearing-aid satisfaction, by using the Glasgow Hearing Aid Benefit Profile (GHABP), and International Outcome Inventory - Hearing Aid (IOI-HA), questionnaires and g) evaluation of stress level and depression by using BECK-II and STAI questionnaires.
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing aid users satisfaction
Glasgow Hearing Aid Benefit Profile (GHABP), patients choose and answer from 0-5 where 0 is the worst result and 5 the best about their satisfaction
International Outcome Inventory - Hearing Aid (IOI-HA) patients choose one answer between five beginning from the worst feeling to the best (not helping/not worth it/worse - moderate - very helpful/totally worth it)
Measured: 20 minutes
Listening effort
Spatial Hearing Questionnaire (SHQ), in which patients rate from 0-100 each question (0 is the worst condition and 100 the best)
Intelligibility test in noise Time response in intelligibility test
Measured: 40 minutes
Cognitive function
Mini-Mental State Examination, 1 point for each correct answer maximun score: 30 - minimum score:24
Measured: 15 minutes
Anxiety or depression
State-Trait Anxiety Inventory (STAI) .Higher scores are positively correlated with higher levels of anxiety
Beck's Depression Inventory (BECK-II) Higher total scores indicate more severe depression
Measured: 20 minutes
Listening effort and cognitive impairment.
Correlation between intelligibility test results, and time response, Spatial Hearing Questionnaire (SHQ) and Mini-Mental State Examination
Measured: 10 minutes
Listening effort and Hearing aid users satisfaction
Correlation between intelligibility test results, and time response, Spatial Hearing Questionnaire (SHQ) and Glasgow Hearing Aid Benefit Profile (GHABP), International Outcome Inventory - Hearing Aid (IOI-HA)
Measured: 10 minutes
Hearing aid users satisfaction and Anxiety or depression
Correlation between Glasgow Hearing Aid Benefit Profile (GHABP), International Outcome Inventory - Hearing Aid (IOI-HA) and State-Trait Anxiety Inventory (STAI), Beck's Depression Inventory (BECK-II)
Measured: 10 minutes
Listening effort and Anxiety or depression
Correlation between intelligibility test results, and time response, Spatial Hearing Questionnaire (SHQ) and State-Trait Anxiety Inventory (STAI), Beck's Depression Inventory (BECK-II)
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start30 Mar 2023 (estimated)
- Primary completion15 Dec 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Listening EffortStudies 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
- 80 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Chania General Hospital "St. George"
- Sponsor type
- University, hospital or other
- Collaborators
- University of Thessaly
- Responsible party
- Sponsor
- Investigators
- Chariton Papadakis, MD, PhD, Study chair, Chania General Hospital "St. George"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781126
- Sponsor's protocol ID
- ENT_CHANIA_02
- Status last verified
- Jan 2023
- First submitted
- 23 Jan 2023
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Listening Effort, Cognition Status, and Anxiety or Depression in Listening Satisfaction by Hearing Aid Users
- ClinicalTrials.gov ID
- NCT05781126
- Acronym / sponsor ID
- ENT_CHANIA_02
- Conditions
- Listening Effort, Cognitive Function 1, Social, Anxiety, Depression, Satisfaction, Consumer, Amplification
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chania General Hospital "St. George"University, hospital or other
- Collaborators
- University of Thessaly
- Study start
- 30 Mar 2023 (estimated)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 23 Mar 2023 (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.
Brief Summary Introduction: Listening can be effortful in situations that require the intensive use of cognitive processing resources especially for individuals with a hearing loss. Hearing-impaired listeners are under a greater degree of cognitive challenge during a hearing task, speech comprehension, memory, response in an auditory message. Listening effort is defined as 'the attention and cognitive resources required to understand speech'. Hearing ability is the strongest predictor of speech understanding accuracy, but cognitive factors, psychological state of the listener and stress also play a significant role. Although there is no gold-standard method for listening effort assessment. a wide range of techniques is used such as: a) self-report methods, b) behavioral measures, or c) physiological measures. Cognitive functioning refers to multiple mental abilities, including receiving visual and auditory message, decision making, processing information and memory skills. During the ageing process there is a decline in cognitive function. The most common tools to measure it are: a) Montreal Cognitive Assessment (MoCA) test b) Mini-Mental State Exam (MMSE), and c) το Mini Cog. Within the older adult population with hearing loss, prevalence estimates that up to 20% report a clinically relevant level of depression symptoms that would necessitate treatment. A cross-sectional association between hearing loss and depression among older adults has been consistently observed. A reduction in activities of daily living observed in older adults with hearing loss, suggesting that disengagement in activities post-hearing loss may contribute to depression. The satisfaction due to amplification for the hearing aid- user is effected by the changes in his everyday routine and also depend on the level of his cognitive function, motivation, psychological status and social environment. Purpose: The purpose of this study is to investigate the effect of listening effort, cognitive function, stress and depression on amplification satisfaction for adult hearing aid-users. Methods and materials: This is a prospective study including patients examined in the outpatient department of ENT clinic in General Hospital of Chania. Patients fulfilling the inclusion criteria will undergo: a) medical history record, b) ENT examination, c) pure tone audiogram and speech audiometry (with and without the hearing amplification) d) listening effort evaluation (with and without the hearing amplification) Self-report and behavioral methods will be used: Evaluation of subjective performance (Spatial Hearing Questionnaire (SHQ) Evaluation of time response in auditory message Evaluation of speech comprehension with background noise or a competitive speaker e) cognitive function evaluation by using the Greek version of Mini-Mental State Examination, f) evaluation of hearing-aid satisfaction, by using the Glasgow Hearing Aid Benefit Profile (GHABP), and International Outcome Inventory - Hearing Aid (IOI-HA), questionnaires and g) evaluation of stress level and depression by using BECK-II and STAI questionnaires. Results: The main outcome will be the assessment of listening effort, cognitive function, psychological status (stress/depression) effect on the level of satisfaction of hearing-aid users. Additional outcomes will be the assessment of the effect of cognitive decline in listening effort and the effect of psychological status on listening effort. Study findings will highlight the potential of changing the approach and management of the hearing aid-users in a way that hearing amplification will lead to satisfaction of their expectations
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from the outpatient ENT clinic of Chania General Hospital.
Key inclusion criteria (4 listed)
- participants aged between 18 and 80 years
- with sensorineural or mixed bilateral hearing loss
- wearing a hearing aid, unilaterally or bilaterally for at least 6 months
- all participants should give a written consent for their participation and the permission for the anonymously use of their results.
Key exclusion criteria (4 listed)
- known neurological disease e.g. neurodegenerative disease (including disease Alzheimer's or dementia), demyelinating disease, metastatic disease
- known psychiatric illness
- illiteracy or non-use of the Greek language
- non-consent to participate in the study.
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 |
|---|---|---|
| The Spatial Hearing Questionnaire, MINI-MENTAL STATE EXAMINATION, International Outcome Inventory - Hearing Aid, Glasgow Hearing Aid Benefit Profile, BECK-II and STAI questionnairesa) medical history record, b) ENT examination, c) pure tone audiogram and speech audiometry (with and without the hearing amplification) d) listening effort evaluation (with and without the hearing amplification) Self-report and behavioral methods will be used: Evaluation of subjective performance (Spatial Hearing Questionnaire (SHQ) Evaluation of time response in auditory message Evaluation of speech comprehension with background noise or a competitive speaker e) cognitive function evaluation by using the Greek version of Mini-Mental State Examination, f) evaluation of hearing-aid satisfaction, by using the Glasgow Hearing Aid Benefit Profile (GHABP), and International Outcome Inventory - Hearing Aid (IOI-HA), questionnaires and g) evaluation of stress level and depression by using BECK-II and STAI questionnaires. | Diagnostic test | – |
Primary outcome
Hearing aid users satisfaction
Time frame: 20 minutes
Glasgow Hearing Aid Benefit Profile (GHABP), patients choose and answer from 0-5 where 0 is the worst result and 5 the best about their satisfaction International Outcome Inventory - Hearing Aid (IOI-HA) patients choose one answer between five beginning from the worst feeling to the best (not helping/not worth it/worse - moderate - very helpful/totally worth it)
Listening effort
Time frame: 40 minutes
Spatial Hearing Questionnaire (SHQ), in which patients rate from 0-100 each question (0 is the worst condition and 100 the best) Intelligibility test in noise Time response in intelligibility test
Cognitive function
Time frame: 15 minutes
Mini-Mental State Examination, 1 point for each correct answer maximun score: 30 - minimum score:24
Anxiety or depression
Time frame: 20 minutes
State-Trait Anxiety Inventory (STAI) .Higher scores are positively correlated with higher levels of anxiety Beck's Depression Inventory (BECK-II) Higher total scores indicate more severe depression
Listening effort and cognitive impairment.
Time frame: 10 minutes
Correlation between intelligibility test results, and time response, Spatial Hearing Questionnaire (SHQ) and Mini-Mental State Examination
Listening effort and Hearing aid users satisfaction
Time frame: 10 minutes
Correlation between intelligibility test results, and time response, Spatial Hearing Questionnaire (SHQ) and Glasgow Hearing Aid Benefit Profile (GHABP), International Outcome Inventory - Hearing Aid (IOI-HA)
Hearing aid users satisfaction and Anxiety or depression
Time frame: 10 minutes
Correlation between Glasgow Hearing Aid Benefit Profile (GHABP), International Outcome Inventory - Hearing Aid (IOI-HA) and State-Trait Anxiety Inventory (STAI), Beck's Depression Inventory (BECK-II)
Listening effort and Anxiety or depression
Time frame: 10 minutes
Correlation between intelligibility test results, and time response, Spatial Hearing Questionnaire (SHQ) and State-Trait Anxiety Inventory (STAI), Beck's Depression Inventory (BECK-II)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
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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.
Chariton Papadakis, MD, PhD study chair
Chania General Hospital "St. George"
Questions about this trial
What is this clinical trial studying?
An observational study of Listening Effort and Cognitive Function 1, Social, run by Chania General Hospital "St. George".
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eleni Tsakiraki, MD (+306971906758, elen.tsak30@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearing aid users satisfaction (time frame: 20 minutes). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2023.