Smartphone Application–Mediated, Supervised, At-Home Telespirometry Identifies Statistically Significant Differences in Erect and Supine SVC

Topic:

Clinical Trials

Poster Number: 196 M

Author(s):

Eufrosina Young, MD, SUNY Upstate Medical University, Syracuse, New York, USA, Dongliang Wang, PhD, SUNY Upstate Medical University, George Slavinski, RRT, SUNY Upstate Medical University, Dragos Manta, MD, SUNY Upstate Medical University, Birendra Sah, MD, SUNY Upstate Medical University, Urvi Desai, MD, Atrium Neurosciences Institute, Charlotte, NC, Lena Deb, SUNY Upstate Medical University, Marielle Posmik, SUNY Upstate Medical University, Jeffrey Collins, RN, SUNY Upstate Medical University, Emma Blystone, SUNY Upstate Medical University, Jenny A Meyer, MD, SUNY Upstate Medical University, Grace Biso, MD, SUNY Upstate Medical University, Darshana Vijaywargiya, MD, SUNY Upstate Medical University, Sara Abdelhafiz, MD, SUNY Upstate Medical University, Takuya Kudo, MS, Tanabe Pharma Inc., Kinjal Patel, MBA, Tanabe Pharma America Inc., Stephen Apple, MD, Tanabe Pharma America, Inc., Jersey City, NJ, USA, Benjamin Rix Brooks, MD, Clinical Trials Plannind LLC, Charlotte, NC

Objective:
Measure erect/supine slow vital capacity (eSVC/sSVC) and ALS Functional Rating Scale-Revised (ALSFRS-R) twice monthly up to 6 months via at-home telespirometry (AHT) in ALS subjects between quarterly in-clinic eSVC/sSVC assessments in a multicenter, prospective, longitudinal, observational clinical study [NCT05106569] using ZEPHYRx™ Breathe Easy software and Remote Respiratory Monitoring™/Provider Dashboard.

Background:
eSVC/sSVC, assessed longitudinally in ALS subjects based on NIV use, declined faster with baseline eSVC ≤80% vs
>80% predicted. eSVC/sSVC declined slower in NIV non-users and those on NIV at entry only vs those who started NIV during the study. In a linear mixed methods analysis, mean ALSFRS-R total score declined faster with eSVC ≤80% vs
>80% predicted at baseline, and mean ALSFRS-R total score declined faster in subjects who started NIV during the study.

Methods:
eSVC/sSVC were measured longitudinally via AHT. ALSFRS-R changes were examined longitudinally alongside eSVC/sSVC in-clinic or via smartphone. Delta eSVC/sSVC and delta ALSFRS-R total score were analyzed with a linear mixed methods model involving baseline covariates.

Results:
Mean monthly decline rate for ALSFRS-R total score (−1.3 units/month [Q1, Q3=−1.8, −0.5]) of NIV non-users was significantly different (p=0.001) from the monthly decline rate (−2.2 units/month [Q1, Q3=−2.8, −1.2]) for subjects who were not on NIV at baseline but started later. Monthly decline rate for ALSFRS-R total score (−1.2 units/month [Q1, Q3=−1.6, −0.6]) of those on NIV at baseline was not different vs ALS subjects not on NIV.

Conclusions:
This study of smartphone–mediated AHT eSVC/sSVC measurement identified statistically significant differences in monthly decline of eSVC/sSVC and ALSFRS-R total score between subjects not requiring NIV and those on NIV vs subjects not on NIV at baseline who started NIV during the study. NIV use, due to its potential to alter both respiratory and motor function, needs to be more carefully captured in clinical studies to permit correct conclusions regarding interventions.