HEARS-SLP: Providing SLP-Delivered Hearing Health Care to Individuals With Cognitive Impairment

Dementia Clinical Trial

Official title:

HEARS-SLP: Providing Speech Language Pathologist-Delivered Hearing Health Care to Individuals With Cognitive Impairment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06008782
• Other study ID #: IRB00218068
• Secondary ID: K23AG059900
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Johns Hopkins University
• Contact: Carrie L Nieman, MD, MPH
• Phone: 410-502-6965
• Email: cnieman1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Building upon the HEARS audiologist-community health worker (CHW) model, this study intervention will be delivered by a speech-language pathologist (SLP). The primary objective of the study is to develop and test an affordable and accessible hearing rehabilitative intervention that will be delivered by a SLP to individuals with cognitive impairment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

Inclusion Criteria:

• Age 60 - 100 years old

• English-speaking

• Lives at home

• Diagnosis of probable Alzheimer's Disease or other related dementia according to the core clinical criteria outlined in the National Institute on Aging (NIA) and Alzheimer's Association Guidelines

• Availability of caregiver/study partner to participate in all study-related visits and who provides =8 hours of weekly oversight/care

• Speech frequency pure tone average (0.5- 4 kHz) >25 db in the better-hearing ear; adult onset hearing loss

• Stable (for 2 weeks or longer) dosing of medication (e.g. antidepressants, antipsychotics) for neuropsychiatric symptoms

Exclusion Criteria:

• Current self-reported use of hearing aid or amplification device

• Medical contraindication to use hearing aids ( e.g. draining ears)

• Inability to participate in the 1-month follow up

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Dementia
• Hearing Loss

Intervention

Device:
• HEARS-SLP device
Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.

Behavioral:
• HEARS-SLP program
Tailored aural rehabilitation for participant and communication partner

Locations

Country	Name	City	State
United States	Johns Hopkins Medicine	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Tuley MR, Mulrow CD, Aguilar C, Velez R. A critical reevaluation of the Quantified Denver Scale of Communication Function. Ear Hear. 1990 Feb;11(1):56-61. doi: 10.1097/00003446-199002000-00011. — View Citation

Ventry IM, Weinstein BE. Identification of elderly people with hearing problems. ASHA. 1983 Jul;25(7):37-42. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Neuropsychiatric Symptoms as assessed by the Neuropsychiatric Inventory (NPI-Q)	Scoring: Each of the 12 NPI-Q domains contains a survey question that reflects symptoms of that domain. Initial responses to each domain question are "Yes" or "No". If the response to the question is "No", the informant goes to the next question. If "Yes", the informant then rates both the Severity of the symptoms present within the last month on a 3-point scale and the associated impact of the symptom manifestations on them using a 5-point scale. The NPI-Q provides symptom Severity and Distress ratings for each symptom reported, and total Severity and Distress scores reflecting the sum of individual domain scores. Total NPI-Q severity score is the sum of individual symptom scores, ranges from 0 to 36.; SEVERITY of the symptom (how it affects the patient): = Mild (noticeable, but not a significant change); = Moderate (significant, but not a dramatic change); = Severe	Baseline and 1 month post-intervention (immediate group). 1 month post-baseline (Delayed Group)
Secondary	Change from Baseline in Health-related Quality of Life as assessed by the Quality of Life in Alzheimer's Disease (QOL-AD) scale	Scoring for QOL-AD: Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4.; The total score is the sum of all 13 items. Total scores range from 13 to 52.	Baseline and 1 month post-intervention (immediate group). 1 month post-baseline (Delayed Group)
Secondary	Change From Baseline in Hearing Specific Quality of life as assessed by the Hearing Handicap Inventory for the Elderly (HHIE-S)	Higher scores indicate increased hearing handicap.; Scoring: 0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap An increase in the score from baseline (a positive number) indicates a worsening in hearing handicap.	Baseline and 1 month post-intervention (immediate group). 1 month post-baseline (Delayed Group)