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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorStanford University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hearing aids equipped with motion sensing abilities

    Device

    Participants will wear hearing aids that will assess their movement, and fall risk.

Treatment groups

350 Participants
are divided into 2 treatment groups
Group A: Fall risk assessmentExperimental treatment 1 intervention
Group B: Speech intelligibilityExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Fall risk assessment using CDC's STEADI protocol

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.

Time frame
approximately 15 minutes to assess
2

Timed Up and Go Test

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.

Time frame
approximately 15 minutes to assess
3

30-Second Chair Stand Test

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.

Time frame
approximately 15 minutes to assess
4

4-Stage Balance Test

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.

Time frame
approximately 15 minutes to assess

Secondary outcomes

1

Fall screening questionnaire using CDC's STEADI protocol

Participants are screened using the CDC's "Three Key Questions" which are part of the STEADI Protocol.

Time frame
Approximately 2 minutes.
2

Listening Effort Questionnaire Scale Score

Listening effort scale score measures the participant's perceived listening effort. This outcome is measured in Speech Intelligibility participants only.

Time frame
Approximately 5 minutes.
3

Auditory Lifestyle and Demand Scale Score

Auditory Lifestyle and Demand scale score measures perceived demands of hearing on lifestyle. This outcome is measured in Speech Intelligibility participants only.

Time frame
Approximately 5 minutes.
4

User Experience Questionnaire

Participants rate their experience with the hearing aid regarding the following aspects: perceived difficulty communicating and listening effort in different environments.

Time frame
Approximately 2 minutes.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

Starkey Laboratories, Inc

Collaborator