Telespirometry in Amyotrophic Lateral Sclerosis (ALS)

State University of New York - Upstate Medical University

Status: Invitation-only

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Diagnostic Test: Spirometry

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05106569

1660190

Details and patient eligibility

About

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

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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)

Trial design

100 participants in 2 patient groups

SUNY Upstate

Description:

One of 2 ALS certified treatment centers in USA expected to recruit 50 subjects.

Treatment:

Diagnostic Test: Spirometry

Atrium Health

Description:

One of 2 ALS certified treatment centers in USA expected to recruit 50 subjects.

Treatment:

Diagnostic Test: Spirometry