Recruiting

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

Sponsor:

Stanford University

Code:

NCT05365646

Conditions

Hearing Loss

Dizziness

Vertigo

Fall Related Injury Risk

Fall Prevention

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

Interventions

Hearing aids equipped with motion sensing abilities

Study Details

Brief summary:

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.

Conditions

Hearing Loss

Dizziness

Vertigo

Fall Related Injury Risk

Fall Prevention

Study ID

NCT05365646

Start date

May 23, 2022

Status verified date

Apr, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

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 Design

Enrollment

350 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

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.

experimental: Speech intelligibility

Interventions

Hearing aids equipped with motion sensing abilities

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

Primary outcome measure

Fall risk assessment using CDC's STEADI protocol [ Time Frame: approximately 15 minutes to assess ]
Timed Up and Go Test [ Time Frame: approximately 15 minutes to assess ]
30-Second Chair Stand Test [ Time Frame: approximately 15 minutes to assess ]
4-Stage Balance Test [ Time Frame: approximately 15 minutes to assess ]
Consonant-Nucleus-Consonant (CNC) [ Time Frame: Approximately 10-15 minutes. ]
Quick Speech-in-Noise (QuickSIN) [ Time Frame: Approximately 10-15 minutes. ]
Words-in-Noise (WIN) [ Time Frame: Approximately 10-15 minutes. ]
Nonsense Syllable Test (NST) [ Time Frame: Approximately 10-15 minutes. ]

Central Contacts and Locations

Locations

Stanford Ear Institute

Recruiting

Palo Alto, California, United States, 94303

Contacts

Matthew Fitzgerald, PhD

(650) 724-6015 fitzmb@stanford.edu

Jwala P. Rejimon, AuD

jrejimon@stanford.edu

Principal Investigator:

Kristen K. Steenerson, MD

More Information

Sponsor

Stanford University

Last update posted

Apr 28, 2026

Last verified

Apr, 2026

Keywords

Fall risk
Hearing loss

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-04-28.