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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT05365646
Status
Recruiting
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Conditions

  • Dizziness
  • Fall Prevention
  • Fall Related Injury Risk
  • Hearing Loss
  • Imbalance
  • Speech Intelligibility
  • Vertigo

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Hearing aids equipped with motion sensing abilities — DEVICE
    Participants will wear hearing aids that will assess their movement, and fall risk.

Study Details

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.

Key Dates

Start date
May 23, 2022
Status verified
Apr 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
350 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

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
    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.

Primary Outcome Measure

Fall risk assessment using CDC's STEADI protocol [ Time Frame: approximately 15 minutes to assess ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford Ear InstitutePalo AltoCalifornia94303
Matthew Fitzgerald, PhD
[email protected]
(650) 724-6015
Jwala P. Rejimon, AuD
[email protected]
Kristen K. Steenerson, MD (PRINCIPAL_INVESTIGATOR)

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