Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device
概览
- 阶段
- 不适用
- 干预措施
- Hearing aids equipped with motion sensing abilities
- 疾病 / 适应症
- Hearing Loss
- 发起方
- Stanford University
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- Fall risk assessment using CDC's STEADI protocol
- 状态
- 招募中
- 最后更新
- 4天前
概览
简要总结
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.
研究者
Kristen K. Steenerson, MD
Clinical Associate Professor in Otoneurology
Stanford University
入排标准
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Fall risk assessment
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.
干预措施: Hearing aids equipped with motion sensing abilities
Speech intelligibility
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.
干预措施: Hearing aids equipped with motion sensing abilities
结局指标
主要结局
Fall risk assessment using CDC's STEADI protocol
时间窗: approximately 15 minutes to assess
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.
Timed Up and Go Test
时间窗: approximately 15 minutes to assess
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.
30-Second Chair Stand Test
时间窗: approximately 15 minutes to assess
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.
4-Stage Balance Test
时间窗: approximately 15 minutes to assess
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.
Consonant-Nucleus-Consonant (CNC)
时间窗: Approximately 10-15 minutes.
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.
Quick Speech-in-Noise (QuickSIN)
时间窗: Approximately 10-15 minutes.
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.
Words-in-Noise (WIN)
时间窗: Approximately 10-15 minutes.
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.
Nonsense Syllable Test (NST)
时间窗: Approximately 10-15 minutes.
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.
次要结局
- Fall screening questionnaire using CDC's STEADI protocol(Approximately 2 minutes.)
- Listening Effort Questionnaire Scale Score(Approximately 5 minutes.)
- Auditory Lifestyle and Demand Scale Score(Approximately 5 minutes.)
- User Experience Questionnaire(Approximately 2 minutes.)
- Demographic and Health Questionnaires(Approximately 15 minutes.)
- Orthostatic Blood Pressure(Approximately 15 minutes.)
- Pure-Tone Audiometry(Approximately 15 minutes.)
- Activities-Specific Balance Confidence Questionnaire(Approximately 10 minutes.)
- Speech, Spatial Qualities of Hearing Scale (SSQ)(Approximately 10 minutes.)
- Hearing Aid Data(Approximately 5 minutes.)