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Fall risk assessment for Vertigo

N/A
Recruiting
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year (up to 1 hour per assessment)
Awards & highlights

Study Summary

This trial aims to create and test hearing aids with sensors and AI to help assess and reduce the risk of falls, improve speech clarity, track activity levels, and social interactions. The goal is to use

Who is the study for?
This trial is for people aged 55 or older who use hearing aids in both ears, can consent in English, have concerns about falling (feeling unsteady, worrying about falls, or having fallen before), and can walk without a wheelchair. They also need to have a phone that can run the study's mobile app.Check my eligibility
What is being tested?
The study tests hearing aids with sensors and AI designed to assess fall risk and improve speech clarity in different environments. It aims to enhance safety by reducing falls and improving hearing quality through technology.See study design
What are the potential side effects?
While not explicitly stated, potential side effects may include discomfort from wearing the device, skin irritation around the ear area where the device is worn, or possible auditory issues due to incorrect usage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year (up to 1 hour per assessment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year (up to 1 hour per assessment) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
30-Second Chair Stand Test
4-Stage Balance Test
Consonant-Nucleus-Consonant (CNC)
+4 more
Secondary outcome measures
Auditory Lifestyle and Demand Scale Score
Fall risk assessment using CDC's STEADI protocol
Listening Effort Questionnaire Scale Score
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Speech intelligibilityExperimental Treatment1 Intervention
Participants will wear study hearing aids that are equipped with embedded sensors and artificial intelligence. This will help track their movement and signal if the participant falls or is at fall risk.
Group II: Fall risk assessmentExperimental Treatment1 Intervention
Participants will wear study hearing aids that are equipped with embedded sensors and artificial intelligence. This will help track their movement and signal if the participant falls or is at fall risk.

Find a Location

Who is running the clinical trial?

Starkey Laboratories, IncIndustry Sponsor
3 Previous Clinical Trials
74 Total Patients Enrolled
Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,000 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently being enrolled in this trial?

"According to the details on clinicaltrials.gov, this current research study is actively pursuing participants. The trial was initially listed on 5/23/2022 and most recently revised on 3/21/2024."

Answered by AI

What is the upper limit for patient enrollment in this particular clinical investigation?

"Affirmative, the details on clinicaltrials.gov confirm that recruitment for this research is ongoing. The trial was officially listed on May 23rd, 2022, with the most recent update made on March 21st, 2024. A total of 350 participants are sought from a single designated site."

Answered by AI

Who else is applying?

What site did they apply to?
Stanford Ear Institute
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Loss of hearing so am checking out options before purchasing hearing aids.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device
Kristen K. Steenerson, MD 2022. "Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05365646.
All > Vestibular Migraine > Hearing Loss
~62 spots leftby Oct 2024
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