Treating Hearing Loss to Improve Mood and Cognition in Older Adults

Study Overview
=================
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.

Official Title
-----------------
Sensation and Psychiatry: Linking Age-Related Hearing Loss to Late-Life Depression and Cognitive Decline

Conditions
-----------------
Hearing Loss, Depression

Intervention / Treatment
-----------------
* Device: Phonak Audeo B-R 90 hearing aid device (Active)
* Drug: Duloxetine or escitalopram
* Device: Audeo B-R 90 hearing aid device (Sham)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Antidepressant (AD) + full amplification hearing aids<br>Participant will be randomized to active comparator and will receive escitalopram or duloxetine + active hearing aid for 12 weeks. | Device: Phonak Audeo B-R 90 hearing aid device (Active)<br>* 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<br>Drug: Duloxetine or escitalopram<br>* 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.<br>* Other names: Cymbalta or Lexapro;|
| Sham Comparator: Antidepressant (AD) + Low amplification (sham) hearing aids<br>Participant will be randomized to sham comparator and will receive escitalopram or duloxetine + sham hearing aid for 12 weeks. | Drug: Duloxetine or escitalopram<br>* 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.<br>* Other names: Cymbalta or Lexapro;Device: Audeo B-R 90 hearing aid device (Sham)<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Rating Score for Depression (HRSD) | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression Severity and Improvement (CGI) | 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) | 12 weeks | 
| Social Adjustment Scale Self-Report (SAS-SR) Score | 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. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aging, Late Life Depression