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

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05365646
• Other study ID #: 60900
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2022
• Est. completion date: October 2024

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dizziness
• Hearing Loss
• Vertigo

Intervention

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

Locations

Country	Name	City	State
United States	Stanford Ear Institute	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Starkey Laboratories, Inc

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. This outcome is assessed in Fall Risk Assessment participants only.	approximately 15 minutes to assess on day 1
Primary	Timed Up and Go Test	Duration of time to stand, walk to a line on the floor (3 meters/10 feet away), turn around, return to chair and sit. Participants wear their regular footwear and can use a walking aid if needed. This outcome is assessed in Fall Risk Assessment participants only.	approximately 15 minutes to assess on day 1
Primary	30-Second Chair Stand Test	Number of times participants can stand without using their arms during the test. Participants wear their regular footwear and can use a walking aid if needed. This outcome is assessed in Fall Risk Assessment participants only.	approximately 15 minutes to assess on day 1
Primary	4-Stage Balance Test	Participants who are able to keep their balance for 10 second in each of four positions (feet together, feet staggered, feet in tandem, and single foot stand). They can hold their arms out, or move their body to help keep your balance, but not move their feet. This outcome is assessed in Fall Risk Assessment participants only.	approximately 15 minutes to assess on day 1
Primary	Consonant-Nucleus-Consonant (CNC)	The number and percentage of words and phonemes accurately repeated are measured in aided (using hearing aids) and unaided conditions. This outcome is measured in Speech Intelligibility participants only.	Approximately 10-15 minutes.
Primary	Quick Speech-in-Noise (QuickSIN)	The number and percentage of words and phonemes accurately repeated are measured in ambient noise conditions in aided and unaided conditions. This outcome is measured in Speech Intelligibility participants only.	Approximately 10-15 minutes.
Primary	Words-in-Noise (WIN)	The number and percentage of words and phonemes accurately repeated are measured in muli-talker babble noise conditions in aided and unaided conditions. This outcome is measured in Speech Intelligibility participants only.	Approximately 10-15 minutes.
Primary	Nonsense Syllable Test (NST)	The number and percentage of words and phonemes accurately repeated are measured in continuous noise conditions in aided and unaided conditions. This outcome is measured in Speech Intelligibility participants only.	Approximately 10-15 minutes.
Secondary	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. Assessments are conducted remotely with the clinician or using the app. This outcome is assessed longitudinally at time points determined per participant. This outcome is assessed in Fall Risk Assessment participants only.	up to 1 year (up to 1 hour per assessment)
Secondary	Listening Effort Questionnaire Scale Score	Listening effort scale score measures the participant's perceived listening effort. This outcome is measured in Speech Intelligibility participants only.	Approximately 5 minutes.
Secondary	Auditory Lifestyle and Demand Scale Score	Auditory Lifestyle and Demand scale score measures perceived demands of hearing on lifestyle. This outcome is measured in Speech Intelligibility participants only.	Approximately 5 minutes.
Secondary	User Experience Questionnaire	Participants rate their experience with the hearing aid regarding the following aspects: perceived difficulty communicating and listening effort in different environments.	Approximately 2 minutes.