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Recruiting NCT05365646

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

No phase Interventional Hearing Loss Dizziness Vertigo Fall Related Injury Risk

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hearing aids equipped with motion sensing abilities.
Who it may be relevant to
Registry conditions: Hearing Loss, Dizziness, Vertigo, Fall Related Injury Risk. Basic parameters: from 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • 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.]
Secondary outcome measures (10)
  • Fall screening questionnaire using CDC's STEADI protocol [Time frame: Approximately 2 minutes.]
  • Listening Effort Questionnaire Scale Score [Time frame: Approximately 5 minutes.]
  • Auditory Lifestyle and Demand Scale Score [Time frame: Approximately 5 minutes.]
  • User Experience Questionnaire [Time frame: Approximately 2 minutes.]
  • Demographic and Health Questionnaires [Time frame: Approximately 15 minutes.]
  • Orthostatic Blood Pressure [Time frame: Approximately 15 minutes.]
  • Pure-Tone Audiometry [Time frame: Approximately 15 minutes.]
  • Activities-Specific Balance Confidence Questionnaire [Time frame: Approximately 10 minutes.]
  • Speech, Spatial Qualities of Hearing Scale (SSQ) [Time frame: Approximately 10 minutes.]
  • Hearing Aid Data [Time frame: Approximately 5 minutes.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Screening

Study locations

United States · 1 center
  • Stanford Ear Institute — Palo Alto

Publications

  • 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. PMID 33284647
  • 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. PMID 31914373

Identifiers

NCT: NCT05365646 · 60900

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗