Treating Hearing Loss to Improve Mood and Cognition in Older Adults

Phase 4

Completed

Interventions: Device: Phonak Audeo B-R 90 hearing aid device (Active)
Drug: Duloxetine or escitalopram
Device: Audeo B-R 90 hearing aid device (Sham)

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Antidepressant (AD) + full amplification hearing aids	Phonak Audeo B-R 90 hearing aid device (Active)	Participant will be randomized to active comparator and will receive escitalopram or duloxetine + active hearing aid for 12 weeks.
Antidepressant (AD) + full amplification hearing aids	Duloxetine or escitalopram	Participant will be randomized to active comparator and will receive escitalopram or duloxetine + active hearing aid for 12 weeks.
Antidepressant (AD) + Low amplification (sham) hearing aids	Duloxetine or escitalopram	Participant will be randomized to sham comparator and will receive escitalopram or duloxetine + sham hearing aid for 12 weeks.
Antidepressant (AD) + Low amplification (sham) hearing aids	Audeo B-R 90 hearing aid device (Sham)	Participant will be randomized to sham comparator and will receive escitalopram or duloxetine + sham hearing aid for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Hamilton Rating Score for Depression (HRSD)	12 weeks	The patient is rated by a clinician among 24 dimensions (24-item HRSD) with a score on a 3 or 5 point scale. Maximum score is a 74. 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression.

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression Severity and Improvement (CGI)	12 weeks	Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale (range 0-7) that requires the clinician to rate the severity of the patient's illness at the time of assessment: range is from 0 (=normal, not at all ill) to 7 (=extremely ill, among the most extremely ill patients worsening)
Social Adjustment Scale Self-Report (SAS-SR) Score	12 weeks	The SAS-SR contains 54 questions that measure instrumental and expressive role performance over the past 2 weeks. Each question is rated on a 5-point scale. The overall adjustment score is obtained by summing the scores of all the items and dividing by the number of items answered. The SAS-R overall score ranges from 0-270, with higher questions indication more impairment.