Phase 4
N=25
Treating Hearing Loss to Improve Mood and Cognition in Older Adults
Hearing Loss · Depression
Bottom Line
View on ClinicalTrials.gov: NCT03321006 ↗Enrolled (actual)
25
Serious AEs
8.0%
Results posted
Aug 2021
Primary outcome: Primary: Hamilton Rating Score for Depression (HRSD) — 12.04; 13.86 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Phonak Audeo B-R 90 hearing aid device (Active) (Device); Duloxetine or escitalopram (Drug); Audeo B-R 90 hearing aid device (Sham) (Device)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hamilton Rating Score for Depression (HRSD) |
12.04; 13.86 | — |
| SECONDARY Clinical Global Impression Severity and Improvement (CGI) |
3.17; 3.20 | — |
| SECONDARY Social Adjustment Scale Self-Report (SAS-SR) Score |
1.96; 2.10 | — |
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.
Eligibility Criteria
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
- are willing to and capable of providing informed consent and complying with study procedures.
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
- diagnosis of probable Alzheimer's Disease, Vascular Dementia, or Parkinson's Disease
- Mini Mental Status Examination (MMSE) ≤ 24
- current or recent (within the past 4 weeks) treatment with antidepressants, antipsychotics, or mood stabilizers
- current suicidal ideation (HRSD suicide item > 2) with risk of imminent self-harm
- any physical or intellectual disability adversely affecting ability to complete assessments
- acute, severe, or unstable medical or neurological illness
- contraindication to hearing aid placement
- significant retrocochlear pathology or organic brain lesion (e.g., acoustic neuroma) responsible for hearing loss.
- having contraindication (e.g. metal) or unable to tolerate the scanning procedures
Data sourced from ClinicalTrials.gov (NCT03321006). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.