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

Johns Hopkins University

Status: Enrolling

Conditions: Cognitive Impairment; Hearing Loss; Dementia

Treatments: Device: HEARS-SLP device; Behavioral: HEARS-SLP program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06008782

K23AG059900 (U.S. NIH Grant/Contract)

IRB00218068

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 60 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups, including a placebo group

Immediate treatment

Experimental group

Description:

immediate treatment

Treatment:

Behavioral: HEARS-SLP program

Device: HEARS-SLP device

Delayed treatment

Placebo Comparator group

Description:

1 month delayed treatment

Treatment:

Behavioral: HEARS-SLP program

Device: HEARS-SLP device