NCT06238102

Brief Summary

  1. 1.Assess the impact of hearing impairment on cognition
  2. 2.Evaluate the impact of hearing impairment on mental health
  3. 3.Evaluate the impact of hearing impairment on quality of life
  4. 4.Assess the relation between hearing loss and psychiatric disorder

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 2, 2024

Completed
28 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

February 2, 2024

Status Verified

January 1, 2024

Enrollment Period

1 year

First QC Date

January 13, 2024

Last Update Submit

January 31, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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.

    baseline

Interventions

measuring hearing impairment to select patients with hearing loss to evaluate who can this hearing impairment affects their quality of life

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

people with hearing impairment (case) normal people without hearing impairment (control)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 31237108BACKGROUND
  • Shear 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.

    PMID: 11413563BACKGROUND
  • Lin 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.

    PMID: 21320988BACKGROUND
  • BECK 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.

    PMID: 13688369BACKGROUND
  • Nasreddine 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.

    PMID: 15817019BACKGROUND
  • Isaacson B. Hearing loss. Med Clin North Am. 2010 Sep;94(5):973-88. doi: 10.1016/j.mcna.2010.05.003.

    PMID: 20736107BACKGROUND
  • Newman 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.

    PMID: 1783240BACKGROUND

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hossam eldin khalifa, prof

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

January 13, 2024

First Posted

February 2, 2024

Study Start

March 1, 2024

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

February 2, 2024

Record last verified: 2024-01