Treating Hearing Loss to Improve Mood and Cognition in Older Adults

• ClinicalTrials.gov Identifier: NCT03321006
• Recruitment Status: Recruiting
• First Posted: October 25, 2017
• Last Update Posted: August 24, 2020
• Sponsor: New York State Psychiatric Institute
• Collaborator: National Institute on Aging (NIA)
• Information provided by (Responsible Party): Bret Rutherford, New York State Psychiatric Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hearing Loss; Depression	Device: Phonak Audeo B-R 90 hearing aid device (Active); Drug: Duloxetine or escitalopram; Device: Audeo B-R 90 hearing aid device (Sham)	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Sensation and Psychiatry: Linking Age-Related Hearing Loss to Late-Life Depression and Cognitive Decline
• Actual Study Start Date: May 30, 2018
• Estimated Primary Completion Date: May 31, 2021
• Estimated Study Completion Date: May 31, 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	Device: Phonak Audeo B-R 90 hearing aid device (Active); 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; Drug: Duloxetine or escitalopram; 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.; Other Name: Cymbalta or Lexapro
Sham Comparator: 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.	Drug: Duloxetine or escitalopram; 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.; Other Name: Cymbalta or Lexapro; Device: Audeo B-R 90 hearing aid device (Sham); 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

Outcome Measures

Primary Outcome Measures :

1. Hamilton Rating Score for Depression (HRSD) [ Time Frame: 12 weeks ]
   The patient is rated by a clinician among 24 dimensions with a score on a 3 or 5 point scale. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial.

Secondary Outcome Measures :

1. Clinical Global Impression Severity and Improvement (CGI) [ Time Frame: 12 weeks ]
   Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment: 0 normal, not at all ill to 7 Among the most extremely ill patients worsening.
2. Social Adjustment Scale Self-Report (SAS-SR) Score [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 60 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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 ≥ 16
5. have moderate to severe symmetric, bilateral hearing loss (combined PTA of >50dB at 2 and 3 kHz)
6. demonstrate impaired speech discrimination scores (60- 100% on 25 word list testing) in one or both ears
7. no prior history of hearing aid use within the past 6 months
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. current suicidal ideation (HRSD suicide item > 2) with risk of imminent self-harm
7. any physical or intellectual disability adversely affecting ability to complete assessments
8. acute, severe, or unstable medical or neurological illness
9. contraindication to hearing aid placement
10. significant retrocochlear pathology or organic brain lesion (e.g., acoustic neuroma) responsible for hearing loss.
11. having contraindication (e.g. metal) or unable to tolerate the scanning procedures

Contacts and Locations

Contacts

Contact: Carlen Zhu; 646-774-8005; Carlen.zhu@nyspi.columbia.edu

Contact: Bret R Rutherford, MD; 646-774-8660; bret.rutherford@nyspi.columbia.edu

Locations

United States, New York

New York State Psychiatric Institute; Recruiting

New York, New York, United States, 10032

Contact: Yashira Henriquez, MS 646-774-8676 yashira.henriquez@nyspi.columbia.edu

Principal Investigator: Bret R Rutherford, MD

Sponsors and Collaborators

New York State Psychiatric Institute

National Institute on Aging (NIA)

Investigators

• Principal Investigator: Bret Rutherford, MD; New York State Psychiatric Institute

More Information

• Responsible Party: Bret Rutherford, Associate Professor of Clinical Psychiatry, New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT03321006
• Other Study ID Numbers: 7540; R21AG059130 ( U.S. NIH Grant/Contract )
• First Posted: October 25, 2017
• Last Update Posted: August 24, 2020
• Last Verified: August 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Bret Rutherford, New York State Psychiatric Institute:

Aging; Late Life Depression

Additional relevant MeSH terms:

Hearing Loss; Deafness; Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Duloxetine Hydrochloride; Citalopram; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Antidepressive Agents, Second-Generation; Antidepressive Agents; Psychotropic Drugs; Peripheral Nervous System Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Analgesics; Sensory System Agents; Dopamine Agents