ADherence to and adjustment of HEARING aids in clinical routine care as preventive dementia strategy: improvement of cognition and well-being (AD-HEARING)

• Conditions: F06.7; H90; Mild cognitive disorder; Conductive and sensorineural hearing loss

• Registration Number: DRKS00025111
• Lead Sponsor: niversitätsmedizin Göttingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-17
• Study Completion: 2023-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Hearing impairment/loss (WHO definition): bilateral mild to moderate hearing impairment with diffuse visual field defects, i.e. means of auditory thresholds at 0.5, 1,2 or 4 kHz (PTA4) in the range of 20 to 60 dB hearing performance of the less impaired side) indicative for provision with hearing aids (also applicable for patients with asymmetric distribution of hearing impairment needing bilateral hearing aids).
Patients already provided with hearing aids will be included if provision with hearing aids can be significantly optimized (in terms of improved speech understanding. This is typically the case with outdated hearing aids (> 6 years old). In this context, also readjustments of hearing aids or improved use of hearing aids will be rated as optimized treatment.

Patients aged >=60 years will be included.

Exclusion Criteria

Patients with severe hearing impairment/loss (diffuse visual field defects with means of auditory tresholds of >20dB at 0.5, 1, 2 or 4 kHz), and patients indicative of surgical interventions for rehabiliation of hearing impairment will be excluded.

Patients already diagnosed with dementia at screening will be excluded.

Patients without sufficient German language skills will be excluded to allow assessment the Freiburger Sprachtest, and of cognitive and psychological parameter in patients with sufficient German language skills only.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Five primary endpoints (measured pre-/post-provision with hearing aids) have been defined:<br>1) Cognition (CERAD-plus, WAIS-IV digit span scores)<br>2) Symptom burden (SCL-90-S Global Severity Index)<br>3) Quality of life (Euro-HRQoL)<br>4) Depression (GDS)<br>5) Social isolation (LSNS-6)

Secondary Outcome Measures

Name	Time	Method
Scores, subscale and item scores of the following scales:<br>- CERAD-plus<br>- WAIS-IV digit spans<br>- SCL-90-S<br>- Euro-HRQoL<br>- GDS<br>- LSNS-6