An observational study in Amyotrophic Lateral Sclerosis, sponsored by State University of New York - Upstate Medical University. Enrolling by invitation at 2 sites in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-06-13.
Sponsored by State University of New York - Upstate Medical University · Observational
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.
717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.
This study's planned enrollment of 100 is close to the median of 109 across 217 observational studies indexed under Motor Neuron Disease.
Browse Motor Neuron Disease studies →State University of New York - Upstate Medical University is the lead sponsor of 154 studies on the registry; 17 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 4 (36%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects are invited to volunteer and recruited from ALS specialty care outpatient clinics at SUNY Upstate and Atrium Health.
Exclusion Criteria:
One of 2 ALS certified treatment centers in USA expected to recruit 50 subjects.
Diagnostic Test: Spirometry
One of 2 ALS certified treatment centers in USA expected to recruit 50 subjects.
Diagnostic Test: Spirometry
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.
Also known as: Pulmonary Function Test
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
Time frame: 6 months
Change from baseline Amyotrophic Lateral Sclerosis Cognitive Behavioral Screen (ALS-CBCS) ALS Caregiver Behavioral Questionnaire at 6 months
Minimum 0, Maximum 45; Lower scores worse
Time frame: 6 months
Change from baseline Amyotrophic Lateral Sclerosis Treatment Questionnaire
Reports usage of non-invasive ventilation, gastrostomy tube, ALS medications and ALS devices
Time frame: 2 week intervals for 6 months
Plan to share: Yes — The plan is to share Individual Patient Data collected during the study to research team from both sites.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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State University of New York - Upstate Medical University