Study Purpose:
The investigators seek to validate Slow Vital Capacity (SVC) measurement in seated and supine positions using conventional and portable spirometry.Study Status:
Recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Observational
Type of Intervention:
N/A
Intervention Name:
N/A
Placebo:
N/A
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Eufrosina Young, MD, SUNY Upstate
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Full Study Summary:
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 Sponsor:
State University of New York - Upstate Medical University
Estimated Enrollment:
100
Estimated Study Start Date:
04 / 28 / 2021
Estimated Study Completion Date:
04 / 28 / 2023
Posting Last Modified Date:
11 / 03 / 2021
Date Study Added to neals.org:
11 / 03 / 2021
Minimum Age:
18 Years
Maximum Age:
100 Years
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)
SUNY Upstate
Syracuse, New York
13210
United States
Atrium Health
Charlotte, North Carolina
28211
United States