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

Stanford University

Status: Enrolling

Conditions: Vertigo; Speech Intelligibility; Imbalance; Fall Related Injury Risk; Dizziness; Hearing Loss; Fall Prevention

Treatments: Device: Hearing aids equipped with motion sensing abilities

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05365646

60900

Details and patient eligibility

About

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.

Enrollment: 350 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

350 participants in 2 patient groups

Fall risk assessment

Experimental group

Description:

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.

Treatment:

Device: Hearing aids equipped with motion sensing abilities

Speech intelligibility

Experimental group

Description:

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.

Treatment:

Device: Hearing aids equipped with motion sensing abilities