Treating Hearing Loss to Improve Mood and Cognition in Older Adults (NCT03321006) | Clinical Trial Compass
CompletedPhase 4
Treating Hearing Loss to Improve Mood and Cognition in Older Adults
United States25 participantsStarted 2018-05-30
Plain-language summary
Age-related hearing loss (ARHL) is the third most common health condition affecting older adults after heart disease and arthritis and is the fifth leading cause of years lived with disability worldwide. Many hearing-impaired older adults avoid or withdraw from social contexts in which background noise will make it difficult to communicate, resulting in social isolation and reduced communication with family and friends.Social isolation and loneliness have been linked to numerous adverse physical and mental health outcomes, including dementia, depression, and mortality, and they may also lead to declining physical activity and the development of the syndrome of frailty. In this project it is hypothesized that untreated ARHL represents a distinct route to developing Late-life Depression (LLD) and that individuals with comorbid ARHL/LLD are unlikely to respond to treatments (i.e., antidepressant medication) that do not treat the underlying hearing problem. Initial studies suggest remediation of hearing loss using hearing aids or cochlear implantation may decrease depressive symptoms acutely and over the course of 6 to 12 months follow-up. However, the clinical significance of these findings is obscured by lack of rigorous control groups, failure to objectively document hearing aid compliance, and enrollment of study populations lacking syndromal depression or even a threshold symptom score.
Who can participate
Age range60 Years – 99 Years
SexALL
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Inclusion criteria
✓. Age ≥ 60 years
✓. diagnosed with Diagnostic and Statistical Manual (DSM) 5 MDD or Persistent Depressive Disorder
✓. have duration of depression ≥6 months
✓. have 24-item Hamilton Rating Scale for Depression (HRSD) score ≥ 16
✓. have moderate to severe symmetric, bilateral hearing loss (combined PTA of \>50dB at 2 and 3 kHz)
✓. demonstrate impaired speech discrimination scores (60- 100% on 25 word list testing) in one or both ears
✓. no prior history of hearing aid use within the past 6 months
✓. English speaking
Exclusion criteria
✕. diagnosis of substance abuse or dependence (excluding Tobacco Use Disorder) within the past 12 months
✕. history of psychosis, psychotic disorder, mania, or bipolar disorder