Treating Hearing Loss to Improve Mood and Cognition in Older Adults
Condition: Hearing Loss; Depression
MeSH terms: Hearing Loss; Deafness; Depression; Depressive Disorder
Intervention: Phonak Audeo B-R 90 hearing aid device (Active); Duloxetine or escitalopram; Audeo B-R 90 hearing aid device (Sham)
Intervention description: Hearing aids will be the latest Audeo B-R 90 devices manufactured by Phonak. Full amplification hearing aids will have their gain determined by audiometric profile as per standard clinical practice; We opted to allow two potential medication choices so that study participation could be offered to individuals who had previously taken one medication and either not responded or not tolerated it. After 4 weeks if subjects do not meet remission criteria (HRSD≤10), the dose of study medication will be increased to escitalopram 20mg or duloxetine 60mg for the remaining 8 weeks of the study.; Hearing aids will be the latest Audeo B-R 90 devices manufactured by Phonak. Low amplification hearing aids will be programmed to a hearing threshold of 10dB across all frequencies
Intervention MeSH terms: Duloxetine Hydrochloride; Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 25.0
Sex: All
Minimum age: 60 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Aging; Late Life Depression

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:

          1. Age ≥ 60 years

          2. diagnosed with Diagnostic and Statistical Manual (DSM) 5 MDD or Persistent Depressive
             Disorder

          3. have duration of depression ≥6 months

          4. have 24-item Hamilton Rating Scale for Depression (HRSD) score ≥ 16

          5. have moderate to severe symmetric, bilateral hearing loss (combined PTA of >50dB at 2
             and 3 kHz)

          6. demonstrate impaired speech discrimination scores (60- 100% on 25 word list testing)
             in one or both ears

          7. no prior history of hearing aid use within the past 6 months

          8. English speaking

          9. are willing to and capable of providing informed consent and complying with study
             procedures.

        Exclusion Criteria:

          1. diagnosis of substance abuse or dependence (excluding Tobacco Use Disorder) within the
             past 12 months

          2. history of psychosis, psychotic disorder, mania, or bipolar disorder

          3. diagnosis of probable Alzheimer's Disease, Vascular Dementia, or Parkinson's Disease

          4. Mini Mental Status Examination (MMSE) ≤ 24

          5. current or recent (within the past 4 weeks) treatment with antidepressants,
             antipsychotics, or mood stabilizers

          6. current suicidal ideation (HRSD suicide item > 2) with risk of imminent self-harm

          7. any physical or intellectual disability adversely affecting ability to complete
             assessments

          8. acute, severe, or unstable medical or neurological illness

          9. contraindication to hearing aid placement

         10. significant retrocochlear pathology or organic brain lesion (e.g., acoustic neuroma)
             responsible for hearing loss.

         11. having contraindication (e.g. metal) or unable to tolerate the scanning procedures