The Effect of Listening Effort, Cognition and Anxiety-depression in Listening Satisfaction by Hearing Aid Users

NCT05781126 | Unknown

• 1 other identifier: ENT_CHANIA_02
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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. 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; Hearing Aid

Outcome Measures

Primary Outcomes (8)

• 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)

  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

  40 minutes

• Cognitive function

  Mini-Mental State Examination, 1 point for each correct answer maximun score: 30 - minimum score:24

  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

  20 minutes

• Listening effort and cognitive impairment.

  Correlation between intelligibility test results, and time response, Spatial Hearing Questionnaire (SHQ) and Mini-Mental State Examination

  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)

  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)

  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)

  10 minutes

Interventions

The Spatial Hearing Questionnaire, MINI-MENTAL STATE EXAMINATION, International Outcome Inventory - Hearing Aid, Glasgow Hearing Aid Benefit Profile, BECK-II and STAI questionnaires DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from the outpatient ENT clinic of Chania General Hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chania General Hospital "St. George": lead
• University of Thessaly: collaborator

MeSH Terms

Conditions

Anxiety Disorders; Depression; Consumer Behavior

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Chariton Papadakis, MD, PhD

  Chania General Hospital "St. George"

  STUDY CHAIR

Central Study Contacts

Eleni Tsakiraki, MD

CONTACT

+306971906758; elen.tsak30@gmail.com

Theognosia Chimona, MD, PhD

CONTACT

+306945432145; chimonath@yahoo.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: March 23, 2023
• Study Start: March 30, 2023
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: March 23, 2023

Record last verified: 2023-01