Home Telemonitoring of Bulbar Function by Acoustic Measurement of Swallowing and Speech Sounds in ALS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Digital recording of speech and swallow
研究概览
简要总结
The investigators propose a longitudinal home study of ALS patients to measure the severity of speech and swallowing (bulbar) impairment via a smartphone-based, remote speech and swallow assessment (rSSA). The study is designed to assess the feasibility and validity of such a monitoring intervention. Furthermore, it is proposed that regular monitoring of these two bulbar processes may shed light on their co-evolution over the course of ALS.
详细描述
Most individuals with ALS experience bulbar function deterioration over the course of the disease which impacts their quality of life significantly. Furthermore, in some patients, bulbar symptoms are an initial presenting symptom of ALS. Identifying these changes, which may be rapid in some individuals, is complicated by the recent acceleration of virtual care delivery.
The investigators propose a longitudinal home study of ALS patients to assess bulbar progression via a smartphone-based, self-administered remote speech and swallow assessment (rSSA). The overall hypothesis is that this monitoring protocol can be used in a way that, 1) is satisfactory to the patient, 2) performs at least as well as standard clinical measures of dysarthria and dysphagia, and 3) resolves the development of emergence of speech and swallowing pathologies in ALS.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years of age
- •Possess a diagnosis of ALS (definite, probable, probable laboratory-supported, or possible by El Escorial criteria [35])
- •Have symptom onset within the last 3 years
- •Demonstrate a score of 2 or 3 in either the speech (item #1) or swallowing (item #3) components of the ALSFRS-R at time of enrollment
- •Demonstrate decline in bulbar function prior to enrollment, measured by a reduction of at least 1 point on either the speech or swallowing components of the ALSFRS-R in the 6 months prior to enrollment. If 6 months of data is not available, an estimate of the change in ALSFRS-R will be calculated from the time of symptom onset.
- •Have a life expectancy ≥ 6 months as determined by the attending neurologist
- •Be fluent in written and spoken English
- •Possess a smartphone capable of running the study application
- •Follow up in the Penn State Hershey multidisciplinary ALS clinic over next 6 months
- •Be able to visit the study site for in-person procedures at weeks 0 and 24
- •Between 18 and 40 years of age
- •Native speakers of American English 2.
- •Currently residing within the United States. 3.
- •Hearing within normal limits, as defined by self report.
排除标准
- •Possess a co-existing neurological or psychiatric illness that, in the opinion of the study team, exclude the subject from participation
- •Demonstrate clinically significant dementia, as determined by the ALS study neurologist
- •Possess abnormal speech or swallowing processes due to a condition independent of their ALS diagnosis
- •Have an identified speech, language, learning, or neurological disorders per self-report
- •Experience communicating with people with motor speech disorders
研究组 & 干预措施
ALS Patients
All ALS patients will be enrolled in this arm, which involves a combination of clinical and home-based assessments of speech and swallowing.
干预措施: Digital recording of speech and swallow sounds using the Beiwe Digital Health App on a personal smartphone (Device)
ALS Patients
All ALS patients will be enrolled in this arm, which involves a combination of clinical and home-based assessments of speech and swallowing.
干预措施: Modified Barium Swallow Study (MBSS) (Radiation)
ALS Patients
All ALS patients will be enrolled in this arm, which involves a combination of clinical and home-based assessments of speech and swallowing.
干预措施: Speech Intelligibility Test (SIT) (Behavioral)
Listeners
Healthy listeners will be recruited to listen to the audio recordings of patients in the study in order to judge the intelligibility of their speech.
干预措施: SIT Scoring (Behavioral)
结局指标
主要结局
Digital recording of speech and swallow
时间窗: weekly for 24 weeks
Audio recordings of speech tasks and spontaneous swallowing task
次要结局
- Maximal Inspiratory Pressure (MIP)(Weeks 0, 12, and 24)
- Speech Intelligibility Task (SIT) Intelligibility listener scoring(Weeks 0, 12, and 24)
- ALS Functional Rating Scale - Revised (ALSFRS-R)(Weeks 0, 12, and 24)
- MBS Impairment Profile (MBSImp)(Weeks 0 and 24)
- Center for Neurological Study - Bulbar Function Scale (CNS-BFS)(Weeks 0, 4, 8, 12, 16, 20, and 24)
- Mann Assessment of Swallowing Ability (MASA)(Weeks 0, 12, and 24)
- EAT-10 Questionnaire(Weeks 0, 12, and 24)
- Forced Vital Capacity (FVC)(Weeks 0, 12, and 24)
研究者
Andrew Geronimo
Assistant Professor, Neurosurgery
Milton S. Hershey Medical Center