Home-Based Spirometry Through Telemedicine in Amyotrophic Lateral Sclerosis (ALS)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change from baseline Dyspnea in Amyotrophic Lateral Sclerosis 15 (DALS-15)
研究概览
简要总结
The investigators seek to validate Slow Vital Capacity (SVC) measurement in seated and supine positions using conventional and portable spirometry.
详细描述
SVC is obtained with in-clinic conventional spirometry, in-clinic portable spirometry, and in-home portable spirometry with respiratory therapist-supervised remote pulmonary function testing every two weeks in a six month prospective study of participants with a diagnosis of Amyotrophic Lateral Sclerosis. SVC decline over time, seated and supine, will be tracked with assessments for treatment changes.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ALS as Clinically Possible, Clinically Probable, Laboratory-supported Probable and Clinically Definite ALS
- •18 years old to 100 years old, English-speaking ALS subjects, male and female
排除标准
- •Use of non-invasive ventilation more than 16 hours daily
- •Non-English Speaker
- •Psychosis or severe mental illness
- •Use of high-dose sedating psychotropic medications determined to potentially interfere with task performance
- •Infection Control issues and specific Pulmonary, Cardiac, Vascular contraindications as listed in the Standardization of Spirometry 2019 Update (Graham 2019)
结局指标
主要结局
Change from baseline Dyspnea in Amyotrophic Lateral Sclerosis 15 (DALS-15)
时间窗: 2 week intervals for 6 months
Minimum 0, Maximum 30; Higher scores worse
Change from baseline Hospital Anxiety and Depression Scale (HADS)
时间窗: 6 months
Minimum 0, Maximum 42; Higher scores worse
Change from baseline Amyotrophic Lateral Sclerosis Assessment Questionnaire-5 (ALSAQ-5) at 6 months
时间窗: 6 months
Minimum 0, Maximum 20; Higher scores worse
Change from baseline in ALS Functional Rating Scale, Revised (ALS FRSR)
时间窗: 2 week intervals for 6 months
Minimum 0, Maximum 48; Lower scores worse
Change from baseline SVC percent predicted at clinic
时间窗: 6 months
SVC measured at clinic in seated and supine positions using conventional and portable spirometer
Change from baseline SVC percent predicted at home
时间窗: 2 week intervals for 6 months
SVC measured from home in seated and supine positions using portable spirometer
Change from baseline Amyotrophic Lateral Sclerosis Treatment Questionnaire
时间窗: 2 week intervals for 6 months
Reports usage of non-invasive ventilation, gastrostomy tube, ALS medications and ALS devices
Change from baseline Amyotrophic Lateral Sclerosis Cognitive Behavioral Screen (ALS-CBCS)
时间窗: 6 months
Minimum 0, Maximum 20; Lower scores worse
Change from baseline Amyotrophic Lateral Sclerosis Cognitive Behavioral Screen (ALS-CBCS) ALS Caregiver Behavioral Questionnaire at 6 months
时间窗: 6 months
Minimum 0, Maximum 45; Lower scores worse
次要结局
未报告次要终点
研究者
Eufrosina I. Young
Principal Investigator
State University of New York - Upstate Medical University