Hearing LossNCT06238102
Psychiatric and Cognitive Assessment of Adult Patients With Hearing Impairment
An observational study of Hearing Loss, run by Assiut University.
Trial summary
1. Assess the impact of hearing impairment on cognition 2. Evaluate the impact of hearing impairment on mental health 3. Evaluate the impact of hearing impairment on quality of life 4. Assess the relation between hearing loss and psychiatric disorder Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- pure tone audiometry
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 Mar 2025
- 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
- Adult, Older adult
Study population: people with hearing impairment (case) normal people without hearing impairment (control)
Who may be able to join
- All patients diagnosed with hearing impairment
- Age : 18 years and above
- Gender: both sexes are included
- willing to participate in the study
- willing and able to provide informed consent
Who cannot join
- Patients with intellectual disabilities
- Patient with previous psychiatric and cognitive disorders
- Patients with neurological diseases that affect hearing
- Patients with history of chronic/ significant medical condition
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Psychiatric and Cognitive Assessment of Adult Patients With Hearing Impairment: the Impact on Quality of Life
- Assess the impact of hearing impairment on cognition
- Evaluate the impact of hearing impairment on mental health
- Evaluate the impact of hearing impairment on quality of life
- Assess the relation between hearing loss and psychiatric disorder
Read the detailed description
Hearing impairment is described as the partial or total loss of hearing ability. On the basis of the severity of the problem hearing impairment can be classified as mild, moderate, severe and profound. Age related hearing impairment is a very common disorder in older adulthood. It is considered as third most prevalent chronic health condition in people over 65 years of age. Hearing impairment in old age typically stems from some pathological changes inside the ear which are related to aging, it may lead to the impairment of low to high frequency hearing. This problem comes up with greater difficulty in listening process that significantly impairs person's ability to communicate with others, which in turn is a serious concern related to the mental health of individual.
It has been reported that adults with hearing loss tend to exhibit more symptoms of depression, anxiety, psychological distress, and emotional sensitivity as compared to people with normal hearing.
Hearing loss poses a serious risk to the mental well-being and overall quality of life in older adults. People may experience diminished self-esteem that in effect leads to the poor mental health and decline in psychological well-being.
Also, recent studies have demonstrated independent associations of hearing loss with incident dementia.
In Egypt such studies are lacking so investigators try to assess the impact of hearing loss on Psychiatry, Cognition and Quality of life by psychiatric interview, psychometric assessment , cognition assessment and quality of life assessment.
the aim is to evaluate the impact of hearing impairment on the above domains in Egypt
- Conditions
- Hearing Loss
- Being tested
- pure tone audiometry
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pure tone audiometryOther
measuring hearing impairment to select patients with hearing loss to evaluate who can this hearing impairment affects their quality of life
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the impact of hearing impairment on mental health by using Beck's depression scale
we will use Beck's depression scale which is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression. The highest possible total for the whole test would besixty-three.the lowest possible score for the test would be zero. High score indicate worse outcome
Measured: baseline
Evaluate the impact of hearing impairment on cognition by using montreal cognitive assessment
we will use MoCA to assess cognition among people with hearing impairment. MoCA is widely used screening assessment for detecting cognitive impairment. It includes 11 questions with a maximum score of 30,a score of less than 24 indicates mild cognitive impairment
Measured: baseline
Evaluate the impact of hearing impairment on quality of life by using hearing handicap inventory for adults
the Hearing Handicap Inventory for Adults (HHIA), is a 25-item self-assessment scale composed of two subscales (emotional and social/situational).this scale varies between 0 and 100; the social scale score can vary between 0 and 48 and the emotional scale can vary between 0 and 52. Higher values indicate a greater perception of the auditory handicap.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Yahia Hanafi mohamed, Assiut University
- Investigators
- Hossam eldin khalifa, prof, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238102
- Sponsor's protocol ID
- Psychiatry and hearing
- Status last verified
- Jan 2024
- First submitted
- 13 Jan 2024
- Last updated
- 2 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Iwagami M, Kobayashi Y, Tsukazaki E, Watanabe T, Sugiyama T, Wada T, Hara A, Tamiya N. Associations between self-reported hearing loss and outdoor activity limitations, psychological distress and self-reported memory loss among older people: Analysis of the 2016 Comprehensive Survey of Living Conditions in Japan. Geriatr Gerontol Int. 2019 Aug;19(8):747-754. doi: 10.1111/ggi.13708. Epub 2019 Jun 24.
PubMed 31237108Shear MK, Vander Bilt J, Rucci P, Endicott J, Lydiard B, Otto MW, Pollack MH, Chandler L, Williams J, Ali A, Frank DM. Reliability and validity of a structured interview guide for the Hamilton Anxiety Rating Scale (SIGH-A). Depress Anxiety. 2001;13(4):166-78.
PubMed 11413563Lin FR, Metter EJ, O'Brien RJ, Resnick SM, Zonderman AB, Ferrucci L. Hearing loss and incident dementia. Arch Neurol. 2011 Feb;68(2):214-20. doi: 10.1001/archneurol.2010.362.
PubMed 21320988BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
PubMed 13688369Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
PubMed 15817019Isaacson B. Hearing loss. Med Clin North Am. 2010 Sep;94(5):973-88. doi: 10.1016/j.mcna.2010.05.003.
PubMed 20736107Newman CW, Weinstein BE, Jacobson GP, Hug GA. Test-retest reliability of the hearing handicap inventory for adults. Ear Hear. 1991 Oct;12(5):355-7. doi: 10.1097/00003446-199110000-00009.
PubMed 1783240
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychiatric and Cognitive Assessment of Adult Patients With Hearing Impairment: the Impact on Quality of Life
- ClinicalTrials.gov ID
- NCT06238102
- Acronym / sponsor ID
- Psychiatry and hearing
- Conditions
- Hearing Loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 2 Feb 2024 (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.
- Assess the impact of hearing impairment on cognition
- Evaluate the impact of hearing impairment on mental health
- Evaluate the impact of hearing impairment on quality of life
- Assess the relation between hearing loss and psychiatric disorder
Detailed description
Hearing impairment is described as the partial or total loss of hearing ability. On the basis of the severity of the problem hearing impairment can be classified as mild, moderate, severe and profound. Age related hearing impairment is a very common disorder in older adulthood. It is considered as third most prevalent chronic health condition in people over 65 years of age. Hearing impairment in old age typically stems from some pathological changes inside the ear which are related to aging, it may lead to the impairment of low to high frequency hearing. This problem comes up with greater difficulty in listening process that significantly impairs person's ability to communicate with others, which in turn is a serious concern related to the mental health of individual.
It has been reported that adults with hearing loss tend to exhibit more symptoms of depression, anxiety, psychological distress, and emotional sensitivity as compared to people with normal hearing.
Hearing loss poses a serious risk to the mental well-being and overall quality of life in older adults. People may experience diminished self-esteem that in effect leads to the poor mental health and decline in psychological well-being.
Also, recent studies have demonstrated independent associations of hearing loss with incident dementia.
In Egypt such studies are lacking so investigators try to assess the impact of hearing loss on Psychiatry, Cognition and Quality of life by psychiatric interview, psychometric assessment , cognition assessment and quality of life assessment.
the aim is to evaluate the impact of hearing impairment on the above domains in Egypt
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- people with hearing impairment (case) normal people without hearing impairment (control)
Key inclusion criteria (5 listed)
- All patients diagnosed with hearing impairment
- Age : 18 years and above
- Gender: both sexes are included
- willing to participate in the study
- willing and able to provide informed consent
Key exclusion criteria (4 listed)
- Patients with intellectual disabilities
- Patient with previous psychiatric and cognitive disorders
- Patients with neurological diseases that affect hearing
- Patients with history of chronic/ significant medical condition
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 |
|---|---|---|
| pure tone audiometrymeasuring hearing impairment to select patients with hearing loss to evaluate who can this hearing impairment affects their quality of life | Other | – |
Primary outcome
Evaluate the impact of hearing impairment on mental health by using Beck's depression scale
Time frame: baseline
we will use Beck's depression scale which is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression. The highest possible total for the whole test would besixty-three.the lowest possible score for the test would be zero. High score indicate worse outcome
Evaluate the impact of hearing impairment on cognition by using montreal cognitive assessment
Time frame: baseline
we will use MoCA to assess cognition among people with hearing impairment. MoCA is widely used screening assessment for detecting cognitive impairment. It includes 11 questions with a maximum score of 30,a score of less than 24 indicates mild cognitive impairment
Evaluate the impact of hearing impairment on quality of life by using hearing handicap inventory for adults
Time frame: baseline
the Hearing Handicap Inventory for Adults (HHIA), is a 25-item self-assessment scale composed of two subscales (emotional and social/situational).this scale varies between 0 and 100; the social scale score can vary between 0 and 48 and the emotional scale can vary between 0 and 52. Higher values indicate a greater perception of the auditory handicap.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Background: PubMed 31237108Iwagami M, Kobayashi Y, Tsukazaki E, Watanabe T, Sugiyama T, Wada T, Hara A, Tamiya N. Associations between self-reported hearing loss and outdoor activity limitations, psychological distress and self-reported memory loss among older people: Analysis of the 2016 Comprehensive Survey of Living Conditions in Japan. Geriatr Gerontol Int. 2019 Aug;19(8):747-754. doi: 10.1111/ggi.13708. Epub 2019 Jun 24.
- Background: PubMed 11413563Shear MK, Vander Bilt J, Rucci P, Endicott J, Lydiard B, Otto MW, Pollack MH, Chandler L, Williams J, Ali A, Frank DM. Reliability and validity of a structured interview guide for the Hamilton Anxiety Rating Scale (SIGH-A). Depress Anxiety. 2001;13(4):166-78.
- Background: PubMed 21320988Lin FR, Metter EJ, O'Brien RJ, Resnick SM, Zonderman AB, Ferrucci L. Hearing loss and incident dementia. Arch Neurol. 2011 Feb;68(2):214-20. doi: 10.1001/archneurol.2010.362.
- Background: PubMed 13688369BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
- Background: PubMed 15817019Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
- Background: PubMed 20736107Isaacson B. Hearing loss. Med Clin North Am. 2010 Sep;94(5):973-88. doi: 10.1016/j.mcna.2010.05.003.
- Background: PubMed 1783240Newman CW, Weinstein BE, Jacobson GP, Hug GA. Test-retest reliability of the hearing handicap inventory for adults. Ear Hear. 1991 Oct;12(5):355-7. doi: 10.1097/00003446-199110000-00009.
Related trials for Hearing Loss
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
Not yet recruiting
Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
Hearing Loss, Bilateral
RecruitingObservational study
Natural History of Autosomal Dominant Hearing Loss
Hearing Loss
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
Cochlear Hearing Loss
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.
Hossam eldin khalifa, prof study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, run by Assiut University.
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 5 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 2 Feb 2024. 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 Ahmed Yahia (01021422304, a7med97yahia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the impact of hearing impairment on mental health by using Beck's depression scale (time frame: baseline). The study lists 3 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 NCT06238102, which also lists 7 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 2 Feb 2024.