Clinical trial NCT05365646: 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
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Loss
Dizziness
Vertigo
Fall Related Injury Risk
Fall Prevention
Imbalance
Speech Intelligibility
Keywords: Fall risk
Hearing loss
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Starkey Laboratories, Inc
First posted: 2022-05-09
Enrollment: 350
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


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.

Primary outcomes:
measure: Fall risk assessment using CDC's STEADI protocol
timeFrame: approximately 15 minutes to assess
measure: Timed Up and Go Test
timeFrame: approximately 15 minutes to assess
measure: 30-Second Chair Stand Test
timeFrame: approximately 15 minutes to assess
measure: 4-Stage Balance Test
timeFrame: approximately 15 minutes to assess
measure: Consonant-Nucleus-Consonant (CNC)
timeFrame: Approximately 10-15 minutes.
measure: Quick Speech-in-Noise (QuickSIN)
timeFrame: Approximately 10-15 minutes.
measure: Words-in-Noise (WIN)
timeFrame: Approximately 10-15 minutes.
measure: Nonsense Syllable Test (NST)
timeFrame: Approximately 10-15 minutes.
Secondary outcomes:
measure: Fall screening questionnaire using CDC's STEADI protocol
timeFrame: Approximately 2 minutes.
measure: Listening Effort Questionnaire Scale Score
timeFrame: Approximately 5 minutes.
measure: Auditory Lifestyle and Demand Scale Score
timeFrame: Approximately 5 minutes.
measure: User Experience Questionnaire
timeFrame: Approximately 2 minutes.
measure: Demographic and Health Questionnaires
timeFrame: Approximately 15 minutes.
measure: Orthostatic Blood Pressure
timeFrame: Approximately 15 minutes.
measure: Pure-Tone Audiometry
timeFrame: Approximately 15 minutes.
measure: Activities-Specific Balance Confidence Questionnaire
timeFrame: Approximately 10 minutes.
measure: Speech, Spatial Qualities of Hearing Scale (SSQ)
timeFrame: Approximately 10 minutes.
measure: Hearing Aid Data
timeFrame: Approximately 5 minutes.
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Ear Institute
state: California
Study officials:
References:
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.
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.