NCT05365646 Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device
| NCT ID | NCT05365646 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stanford University |
| Condition | Hearing Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 350 participants |
| Start Date | 2022-05-23 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 350 participants in total. It began in 2022-05-23 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Frequently Asked Questions
Who can join the NCT05365646 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, studying Hearing Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05365646 currently recruiting?
Yes, NCT05365646 is actively recruiting participants. Visit ClinicalTrials.gov or contact Stanford University to inquire about joining.
Where is the NCT05365646 trial being conducted?
This trial is being conducted at Palo Alto, United States.
Who is sponsoring the NCT05365646 clinical trial?
NCT05365646 is sponsored by Stanford University. The trial plans to enroll 350 participants.