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

Primary Purpose

Hearing Loss, Dizziness, Vertigo

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hearing aids equipped with motion sensing abilities
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hearing Loss

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Participants

    Arm 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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 26, 2022
    Last Updated
    May 3, 2022
    Sponsor
    Stanford University
    Collaborators
    Starkey Laboratories, Inc
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05365646
    Brief Title
    Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device
    Official Title
    Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2022 (Anticipated)
    Primary Completion Date
    January 2024 (Anticipated)
    Study Completion Date
    May 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Stanford University
    Collaborators
    Starkey Laboratories, Inc

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hearing Loss, Dizziness, Vertigo

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    250 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Participants
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Device
    Intervention Name(s)
    Hearing aids equipped with motion sensing abilities
    Intervention Description
    Participants will wear hearing aids that will assess their movement, and fall risk.
    Primary Outcome Measure Information:
    Title
    Fall risk assessment using CDC's STEADI protocol
    Description
    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.
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33284647
    Citation
    Rahme M, Folkeard P, Scollie S. Evaluating the Accuracy of Step Tracking and Fall Detection in the Starkey Livio Artificial Intelligence Hearing Aids: A Pilot Study. Am J Audiol. 2021 Mar 10;30(1):182-189. doi: 10.1044/2020_AJA-20-00105. Epub 2020 Dec 7.
    Results Reference
    background
    PubMed Identifier
    31914373
    Citation
    Burwinkel JR, Xu B, Crukley J. Preliminary Examination of the Accuracy of a Fall Detection Device Embedded into Hearing Instruments. J Am Acad Audiol. 2020 Jun;31(6):393-403. doi: 10.3766/jaaa.19056. Epub 2020 Aug 3.
    Results Reference
    background

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

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