F06.7 H90
Conditions
Interventions
Group 1: Patients with hearing impairment (with bilateral mild to moderate diffuse visual field defects, WHO definition: means of auditory thresholds at 0.5, 1.2 4 kHz (PTA4) in the range of 20 to 60
Sponsors
Universitätsmedizin Göttingen
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
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 This is typically the case with outdated hearing aids (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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Five primary endpoints (measured pre-/post-provision with hearing aids) have been defined: 1) Cognition (CERAD-plus, WAIS-IV digit span scores) 2) Symptom burden (SCL-90-S Global Severity Index) 3) Quality of life (Euro-HRQoL) 4) Depression (GDS) 5) Social isolation (LSNS-6) | — |
Secondary
| Measure | Time frame |
|---|---|
| Scores, subscale and item scores of the following scales: - CERAD-plus - WAIS-IV digit spans - SCL-90-S - Euro-HRQoL - GDS - LSNS-6 | — |
Countries
Germany
Contacts
Public ContactClaudia Bartels
Klinik für Psychiatrie und Psychotherapie, Universitätsmedizin Göttingen
Outcome results
None listed