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

Sponsor
Johns Hopkins University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06008782
Collaborator
National Institute on Aging (NIA) (NIH)
20
Enrollment
2
Arms
12
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: HEARS-SLP device
  • Behavioral: HEARS-SLP program
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
HEARS-SLP: Providing Speech Language Pathologist-Delivered Hearing Health Care to Individuals With Cognitive Impairment
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Immediate treatment

immediate treatment

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
Placebo Comparator: Delayed treatment

1 month delayed treatment

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

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline in Neuropsychiatric Symptoms as assessed by the Neuropsychiatric Inventory (NPI-Q) [Baseline and 1 month post-intervention (immediate group). 1 month post-baseline (Delayed Group)]

    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

Secondary Outcome Measures

  1. Change from Baseline in Health-related Quality of Life as assessed by the Quality of Life in Alzheimer's Disease (QOL-AD) scale [Baseline and 1 month post-intervention (immediate group). 1 month post-baseline (Delayed Group)]

    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.

  2. Change From Baseline in Hearing Specific Quality of life as assessed by the Hearing Handicap Inventory for the Elderly (HHIE-S) [Baseline and 1 month post-intervention (immediate group). 1 month post-baseline (Delayed Group)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Johns Hopkins University
  • National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Esther Oh, MD, PhD, Johns Hopkins School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT06008782
Other Study ID Numbers:
  • IRB00218068
  • K23AG059900
First Posted:
Aug 24, 2023
Last Update Posted:
Aug 25, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hearing Loss
Cognitive Dysfunction

Study Results

No Results Posted as of Aug 25, 2023