Treating Hearing Loss to Improve Mood and Cognition in Older Adults
Condition: Hearing Loss; Depression
MeSH terms: Hearing Loss; Deafness; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      This study will conduct the first clinical trial possessing these design features 40
      individuals will be recruited who are aged ≥60 years, diagnosed with a clinically significant
      depressive disorder, and have moderate ARHL with impaired speech discrimination.
      Comprehensive baseline psychiatric, audiometric, neuropsychological, and functional
      assessment will be performed. Participants then will be randomized to receive antidepressant
      medication (AD) treatment plus full amplification hearing aids or antidepressant medication
      plus low amplification hearing aids over a 12-week prospective trial. Data from this study
      could suggest a novel therapeutic strategy for LLD and thereby mitigate its public health
      burden, while also contributing to the increased recognition and treatment of ARHL more
      generally.
    

Intervention name(s): Phonak Audeo B-R 90 hearing aid device (Active); Duloxetine or escitalopram; Audeo B-R 90 hearing aid device (Sham)
Intervention type(s): Device; Drug; Device
Intervention description(s): 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
Other intervention name(s): Cymbalta or Lexapro
Intervention MeSH terms: Duloxetine Hydrochloride; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Aging; Late Life Depression