Using smart hearing aids to assess and reduce fall risk while improving speech clarity
Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device
This study is testing smart hearing aids that can help older adults not only hear better but also see if they can reduce the risk of falls by tracking their movements and activities.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT05365646 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and validate a method using hearing aids equipped with sensors and artificial intelligence to assess fall risk and implement interventions to reduce falls. The hearing aids will also enhance speech intelligibility in various environments and track physical activity and social engagement. Participants will be individuals aged 55 and older who are bilateral hearing aid users and can consent in English. The study will involve monitoring participants' movements and responses to assess their fall risk and improve their hearing experience.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 55 and older who are bilateral hearing aid users and can engage with a mobile app.
Not a fit: Patients with severe mobility restrictions or advanced cognitive disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce fall risks and improve hearing quality for older adults using hearing aids.
How similar studies have performed: Other studies have shown promise in using technology to assess fall risk and improve hearing, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Palo Alto, California
- Stanford Ear Institute — Palo Alto, California, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.