Sensation and Psychiatry: Linking Age-Related Hearing Loss to Late-Life Depression and Cognitive Decline
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Hamilton Rating Score for Depression (HRSD)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Antidepressant (AD) + full amplification hearing aids
Participant will be randomized to active comparator and will receive escitalopram or duloxetine + active hearing aid for 12 weeks.
干预措施: Phonak Audeo B-R 90 hearing aid device (Active) (Device)
Antidepressant (AD) + full amplification hearing aids
Participant will be randomized to active comparator and will receive escitalopram or duloxetine + active hearing aid for 12 weeks.
干预措施: Duloxetine or escitalopram (Drug)
Antidepressant (AD) + Low amplification (sham) hearing aids
Participant will be randomized to sham comparator and will receive escitalopram or duloxetine + sham hearing aid for 12 weeks.
干预措施: Duloxetine or escitalopram (Drug)
Antidepressant (AD) + Low amplification (sham) hearing aids
Participant will be randomized to sham comparator and will receive escitalopram or duloxetine + sham hearing aid for 12 weeks.
干预措施: Audeo B-R 90 hearing aid device (Sham) (Device)
结局指标
主要结局
Hamilton Rating Score for Depression (HRSD)
时间窗: 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.
次要结局
- Clinical Global Impression Severity and Improvement (CGI)(12 weeks)
- Social Adjustment Scale Self-Report (SAS-SR) Score(12 weeks)
研究者
Bret Rutherford
Associate Professor of Clinical Psychiatry
New York State Psychiatric Institute