NCT04672174

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress92%
Nov 2019Dec 2026

Study Start

First participant enrolled

November 1, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

7.2 years

First QC Date

November 19, 2020

Last Update Submit

March 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

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

    Effect of hearing loss on memory

    2 years

Study Arms (1)

Effect of hearing loss on dementia

OTHER

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

Diagnostic Test: Questionnaire: DemTect

Interventions

Questionnaire: DemTectDIAGNOSTIC_TEST

Questionnaire is handed out to subjects

Effect of hearing loss on dementia

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andrea Kegel

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

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

Study Officials

  • Christof Roosli

    UniversitätsSpital Zürich, ORL-Klinik

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2020

First Posted

December 17, 2020

Study Start

November 1, 2019

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 30, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations