Telespirometry in Amyotrophic Lateral Sclerosis (ALS)

State University of New York - Upstate Medical University100 enrolled

Overview

The investigators seek to validate Slow Vital Capacity (SVC) measurement in seated and supine positions using conventional and portable spirometry.

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Amyotrophic Lateral Sclerosis

Interventions

SpirometryDIAGNOSTIC_TEST

All study participants will undergo pulmonary function testing using conventional spirometry in clinic and portable spirometry in clinic and at home. In-clinic conventional laboratory spirometry is compared with portable spirometry and Slow vital capacity is obtained in upright and supine positions.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Diagnosis of ALS as Clinically Possible, Clinically Probable, Laboratory-supported Probable and Clinically Definite ALS 2. 18 years old to 100 years old, English-speaking ALS subjects, male and female Exclusion Criteria: 1. Use of non-invasive ventilation more than 16 hours daily 2. Non-English Speaker 3. Psychosis or severe mental illness 4. Use of high-dose sedating psychotropic medications determined to potentially interfere with task performance 5. Infection Control issues and specific Pulmonary, Cardiac, Vascular contraindications as listed in the Standardization of Spirometry 2019 Update (Graham 2019)

Locations (2)

SUNY Upstate

Syracuse, New York, United States

Atrium Health

Charlotte, North Carolina, United States

Outcomes

Primary Outcomes

Change from baseline in ALS Functional Rating Scale, Revised (ALS FRSR)

Minimum 0, Maximum 48; Lower scores worse

Time frame: 2 week intervals for 6 months

Change from baseline SVC percent predicted at clinic

SVC measured at clinic in seated and supine positions using conventional and portable spirometer

Time frame: 3 months

Change from baseline SVC percent predicted at clinic

SVC measured at clinic in seated and supine positions using conventional and portable spirometer

Time frame: 6 months

Change from baseline SVC percent predicted at home

SVC measured from home in seated and supine positions using portable spirometer

Time frame: 2 week intervals for 6 months

Change from baseline Dyspnea in Amyotrophic Lateral Sclerosis 15 (DALS-15)

Minimum 0, Maximum 30; Higher scores worse

Time frame: 2 week intervals for 6 months

Change from baseline Hospital Anxiety and Depression Scale (HADS)

Minimum 0, Maximum 42; Higher scores worse

Time frame: 6 months

Change from baseline Amyotrophic Lateral Sclerosis Assessment Questionnaire-5 (ALSAQ-5) at 6 months

Minimum 0, Maximum 20; Higher scores worse

Time frame: 6 months

Change from baseline Amyotrophic Lateral Sclerosis Cognitive Behavioral Screen (ALS-CBCS)

Minimum 0, Maximum 20; Lower scores worse

Data from ClinicalTrials.gov

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