NCT05106569

Telespirometry in Amyotrophic Lateral Sclerosis (ALS)

Home-Based Spirometry Through Telemedicine in Amyotrophic Lateral Sclerosis (ALS)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: State University of New York - Upstate Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-04-28
• Primary completion: 2024-06-30
• Completion: 2024-12-30
• First posted: 2021-11-03
• Last updated: 2023-06-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study