Treating Hearing Loss to Improve Mood and Cognition in Older Adults
| Status: | Recruiting |
|---|---|
| Conditions: | Depression, Other Indications, Other Indications |
| Therapuetic Areas: | Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 60 - 99 |
| Updated: | 10/28/2018 |
| Start Date: | August 15, 2017 |
| End Date: | August 15, 2019 |
| Contact: | Veronika S Bailey, MA |
| Email: | veronika.bailey@nyspi.columbia.edu |
| Phone: | 646-774-8655 |
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.
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.
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.
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.
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 ≥ 18
5. have moderate to severe symmetric, bilateral hearing loss (combined PTA of 50-80 dB at
0.5, 1, 2, 3 kHz)
6. demonstrate impaired speech discrimination scores (50-80% on 25 word list testing)
7. no prior history of hearing aid use
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. history of allergy, hypersensitivity reaction, or severe intolerance to duloxetine or
escitalopram
7. current suicidal ideation (HRSD suicide item > 2) with risk of imminent self-harm
8. any physical or intellectual disability adversely affecting ability to complete
assessments
9. acute, severe, or unstable medical or neurological illness
10. contraindication to hearing aid placement
11. significant retrocochlear pathology or organic brain lesion (e.g., acoustic neuroma)
responsible for hearing loss.
We found this trial at
1
site
1051 Riverside Dr
New York, New York 10032
New York, New York 10032
646-774-5000
Principal Investigator: Bret R Rutherford, MD
Phone: 646-774-8655
New York State Psychiatric Institute The New York State Psychiatric Institute (NYSPI), established in 1895,...
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