search
Back to results

Cognitive Screening Of Patients With Hearing Loss

Primary Purpose

Hearing Loss, Sensorineural

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Questionnaire: DemTect
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hearing Loss, Sensorineural

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • - Age 50 - 90
  • Measurable hearing loss
  • Sufficient knowledge of german
  • Ability to consent

Exclusion Criteria:

  • Age < 50 or >90
  • No measurable hearing loss
  • Present or past alcohol or drug abuse
  • Clinically relevant depressive symptoms
  • lnability to consent

Sites / Locations

  • Andrea Kegel

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Effect of hearing loss on dementia

Arm Description

Effect of hearing loss on dementia, collected with a standardized questionnaire

Outcomes

Primary Outcome Measures

Questionnaire to assess effect of hearing loss on memory (DemTect)
Effect of hearing loss on memory

Secondary Outcome Measures

Full Information

First Posted
November 19, 2020
Last Updated
November 3, 2022
Sponsor
University of Zurich
Collaborators
Universitätsklinikum Köln
search

1. Study Identification

Unique Protocol Identification Number
NCT04672174
Brief Title
Cognitive Screening Of Patients With Hearing Loss
Official Title
Cognitive Screening Of Patients With Hearing Loss
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
Universitätsklinikum Köln

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Hearing loss and cognitive impairment both appear in elderly patients. The goal was to use a modified screening method added to already established cognitive tests to obtain a standardized test for detection of cognitive impairment in patients with hearing loss. The aim of this study is to collect data with neuropsychological tests using questionnaires and to determine cognitive impairment in patients with hearing loss. The collected data will be evaluated using SPSS 23. The corrected item-total correlation and item difficulty of the item DemTectEar will be assessed by item analysis / Cronbachs' Alpha. For further evaluation and comparisons two-sided t-tests with a level of significance 0.05 or Mann-Whitney-U-tests will be performed.
Detailed Description
Cognitive impairment and dementia are a growing health-care problem in our society. The prevalence of dementia is still estimated to grow drastically and reach over a 100 million world-wide by the year 2050. To address this problem there are numerous neuropsychological screening methods, for example the mini-mental state examination (MMSE) or the DemTect. Another age-dependent problem is the increasing hearing impairment. Furthermore, studies have shown that hearing loss is associated with cognitive decline and may accelerate the process. Nevertheless, there is no specific cognitive screening method for patients with a sensory hearing loss. This study aims to obtain a specifically modified version of the general DemTect called DemTectEar for patients with pre-existing hearing loss. Such a screening method would lead to earlier detection, earlier therapy and thereby to deceleration of cognitive decline. Patient charts are screened to identify possible participants. They are contacted to participate in the study during regular clinical follow-up consultations or are contacted by phone or mail. The investigators will explain to each participant the nature of the study, its purpose, the procedures involved, the expected duration, the potential risks and benefits and any discomfort it may entail. Each participant will be informed that the participation in the study is voluntary and that he or she may withdraw from the study at any time and that withdrawal of consent will not affect his or her subsequent medical assistance and treatment. The participant will be informed that his or her medical records may be examined by authorised individuals other than their treating physician. All participants for the study will be provided a participant information sheet and a consent form describing the study and providing sufficient information for participant to make an informed decision about their participation in the study. Enough time, a few days or more if required, will be given to the participant to decide whether to participate or not. The formal consent of a participant, using the approved consent form, will be obtained before the participant is submitted to any study procedure. The consent form will be signed and dated by the investigator or his designee at the same time as the participant sign. A copy of the signed informed consent will be given to the study participant. The consent form will be retained as part of the study records. Study procedures The overall duration of the study is planned to be 12 months starting with the recruitment period on September 2019. The study duration for each patient is planned to be approximately 60 min, in which each patient will be undergoing a series of neuropsychological tests and questionnaires such as: DemTectEar Mini Mental State Examination (MMSE) F-A-S Becks Depressions-Inventar (BOI-V) Bayer-Activities of Daily Living Scale-Skala (B-ADL Skala) Trail Making Test (TMT) Rey-Osterrieth Complex Figure Test - Copy and Recall (ROCFT) Mini-q Test Nürnberger-Alters-Inventar Test (NAI-Labyrinth) Subtest 4 of the Leistungsprüfsystem für 50+ (LPS50+) Subtest 6 of the Leistungsprüfsystem für 50+ Verbaler Lern- und Merkfähigkeitstest (VLMT) Geriatrische Depressionsskala (GDS) Statistical analysis plan and sample size calculation The collected data will be evaluated using SPSS 23. The corrected item-total correlation and item difficulty of the item DemTectEar will be assessed by item analysis / Cronbachs' Alpha. For further evaluation and comparisons two-sided t-tests with a level of significance 0.05 or Mann-Whitney-U-tests will be performed. The primary endpoint consists of a cut-off score between age-appropriate cognitive capability and cognitive impairment. In total, 200 control subjects, 50 patients with a hearing loss and 50 patients with visual impairment will be included for analysis. The majority of these patients is recruited in Köln, and only 20 patients with hearing impairment are investigated in Zürich.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sensorineural

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Effect of hearing loss on dementia
Arm Type
Other
Arm Description
Effect of hearing loss on dementia, collected with a standardized questionnaire
Intervention Type
Diagnostic Test
Intervention Name(s)
Questionnaire: DemTect
Intervention Description
Questionnaire is handed out to subjects
Primary Outcome Measure Information:
Title
Questionnaire to assess effect of hearing loss on memory (DemTect)
Description
Effect of hearing loss on memory
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Age 50 - 90 Measurable hearing loss Sufficient knowledge of german Ability to consent Exclusion Criteria: Age < 50 or >90 No measurable hearing loss Present or past alcohol or drug abuse Clinically relevant depressive symptoms lnability to consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christof Roosli
Organizational Affiliation
UniversitätsSpital Zürich, ORL-Klinik
Official's Role
Principal Investigator
Facility Information:
Facility Name
Andrea Kegel
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cognitive Screening Of Patients With Hearing Loss

We'll reach out to this number within 24 hrs