Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device

April 15, 2024 updated by: Kristen K. Steenerson, MD, Stanford University
The purpose of this study is to develop and validate methods to use hearing aids equipped with embedded sensors and artificial intelligence to assist in the assessment of fall risk and in the implementation of interventions aimed at reducing the risk of falling, as well as to improve speech intelligibility in quiet and in background noise, track physical activity, and social engagement. The investigators hope is that the knowledge that is generated through this study will ultimately translate to the clinical setting and will help reduce the likelihood that individuals experience a fall, and improve the quality of hearing in individuals who wear hearing aids.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

53 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 55 years or older
  • Bilateral hearing aid user
  • Able to consent in English
  • Having access to a phone capable of running the mobile app required for the study
  • Screen for fall risk ("Yes" to any question: Feels unsteady when standing or walking? Worries about falling? Has fallen in past year? If the participant has fallen: how many times? were they injured/hurt?)
  • Ambulatory without need for a wheelchair

Exclusion Criteria:

  • People with mobility restrictions (e.g., wheelchair bound) that would prevent the performance of the functional assessments.
  • People with severe movement (e.g., Advanced Parkinson's disease) or cognitive (e.g., advanced dementia) disorders that would prevent the individual from either performing the functional assessments, or would lead to restricted activities that would prevent motion data from being collected according to the goal of the study.
  • Inability to understand, consent, and complete requirements including verbal instructions and non-ambulatory/wheelchair-dependent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fall risk assessment
Participants will wear study hearing aids that are equipped with embedded sensors and artificial intelligence. This will help track their movement and signal if the participant falls or is at fall risk.
Device: Hearing aids equipped with motion sensing abilities
Participants will wear hearing aids that will assess their movement, and fall risk.
Experimental: Speech intelligibility
Participants will wear study hearing aids that are equipped with embedded sensors and artificial intelligence. This will help track their movement and signal if the participant falls or is at fall risk.
Device: Hearing aids equipped with motion sensing abilities
Participants will wear hearing aids that will assess their movement, and fall risk.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fall risk assessment using CDC's STEADI protocol
Time Frame: approximately 15 minutes to assess on day 1
Participants will undergo the Centers for Disease Control and Prevention (CDC)'s STEADI (Stopping Elderly Accidents, Deaths & Injuries) fall risk assessment with the hearing aids on. The scoring for these tests will be done by the tester, 2 independent raters, and the hearing aids. A comparison of the fall risk assessments by the testers and the hearing aids is the primary outcome measure. This outcome is assessed in Fall Risk Assessment participants only.
approximately 15 minutes to assess on day 1
Timed Up and Go Test
Time Frame: approximately 15 minutes to assess on day 1
Duration of time to stand, walk to a line on the floor (3 meters/10 feet away), turn around, return to chair and sit. Participants wear their regular footwear and can use a walking aid if needed. This outcome is assessed in Fall Risk Assessment participants only.
approximately 15 minutes to assess on day 1
30-Second Chair Stand Test
Time Frame: approximately 15 minutes to assess on day 1
Number of times participants can stand without using their arms during the test. Participants wear their regular footwear and can use a walking aid if needed. This outcome is assessed in Fall Risk Assessment participants only.
approximately 15 minutes to assess on day 1
4-Stage Balance Test
Time Frame: approximately 15 minutes to assess on day 1
Participants who are able to keep their balance for 10 second in each of four positions (feet together, feet staggered, feet in tandem, and single foot stand). They can hold their arms out, or move their body to help keep your balance, but not move their feet. This outcome is assessed in Fall Risk Assessment participants only.
approximately 15 minutes to assess on day 1
Consonant-Nucleus-Consonant (CNC)
Time Frame: Approximately 10-15 minutes.
The number and percentage of words and phonemes accurately repeated are measured in aided (using hearing aids) and unaided conditions. This outcome is measured in Speech Intelligibility participants only.
Approximately 10-15 minutes.
Quick Speech-in-Noise (QuickSIN)
Time Frame: Approximately 10-15 minutes.
The number and percentage of words and phonemes accurately repeated are measured in ambient noise conditions in aided and unaided conditions. This outcome is measured in Speech Intelligibility participants only.
Approximately 10-15 minutes.
Words-in-Noise (WIN)
Time Frame: Approximately 10-15 minutes.
The number and percentage of words and phonemes accurately repeated are measured in muli-talker babble noise conditions in aided and unaided conditions. This outcome is measured in Speech Intelligibility participants only.
Approximately 10-15 minutes.
Nonsense Syllable Test (NST)
Time Frame: Approximately 10-15 minutes.
The number and percentage of words and phonemes accurately repeated are measured in continuous noise conditions in aided and unaided conditions. This outcome is measured in Speech Intelligibility participants only.
Approximately 10-15 minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fall risk assessment using CDC's STEADI protocol
Time Frame: up to 1 year (up to 1 hour per assessment)
Participants will undergo the Centers for Disease Control and Prevention (CDC)'s STEADI (Stopping Elderly Accidents, Deaths & Injuries) fall risk assessment with the hearing aids on. Assessments are conducted remotely with the clinician or using the app. This outcome is assessed longitudinally at time points determined per participant. This outcome is assessed in Fall Risk Assessment participants only.
up to 1 year (up to 1 hour per assessment)
Listening Effort Questionnaire Scale Score
Time Frame: Approximately 5 minutes.
Listening effort scale score measures the participant's perceived listening effort. This outcome is measured in Speech Intelligibility participants only.
Approximately 5 minutes.
Auditory Lifestyle and Demand Scale Score
Time Frame: Approximately 5 minutes.
Auditory Lifestyle and Demand scale score measures perceived demands of hearing on lifestyle. This outcome is measured in Speech Intelligibility participants only.
Approximately 5 minutes.
User Experience Questionnaire
Time Frame: Approximately 2 minutes.
Participants rate their experience with the hearing aid regarding the following aspects: perceived difficulty communicating and listening effort in different environments.
Approximately 2 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

Starkey Laboratories, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2022

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

April 26, 2022

First Submitted That Met QC Criteria

May 3, 2022

First Posted (Actual)

May 9, 2022

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 60900

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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