Smartphone─Mediated At-Home Telespirometry Erect and Supine Slow Vital Capacity Decline Differences Based On NIV Status in Subjects With ALS
Eufrosina Young1, Dongliang Wang1, George Slavinski1, Dragos Manta1, Birenda Sah1, Urvi Desai2, Lena Deb1, Marielle Posmik1, Jeffrey Collins1, Emma Blystone1, Jenny Meyer1, Bhavya Narapureddy1, Ahmed Ibrahim1, Grace Marie Biso1, Darshana Vijaywargiya1, Sara Abdelhafiz1, Pradeep Chevula1, Takuya Kudo3, Kinjal Patel4, Stephen Apple4, Benjamin Rix Brooks5
1SUNY Upstate Medical University, 2Atrium Health Neurosciences Institute, 3Mitsubishi Tanabe Pharma Corporation, 4Mitsubishi Tanabe Pharma America, Inc., 5Clinical Trials Planning LLC
Objective:
Measure erect and supine slow vital capacity (eSVC/sSVC) every two weeks via at-home telespirometry (AHT) in subjects with ALS between quarterly eSVC/sSVC assessments in a prospective, longitudinal, observational clinical study [NCT05106569] with the ZEPHYRx® Remote Respiratory Monitoring™ dashboard and MIR’s Spirobank Smart Spirometer connected to the Breathe Easy application.
Background:
AHT aims to provide earlier treatment of ALS-associated respiratory comorbidities. This first implementation study assessed eSVC/sSVC longitudinally in subjects with ALS in the home between clinic visits.
Design/Methods:
eSVC/sSVC were measured via conventional spirometery during quarterly in-clinic assessments (baseline, 12, 24 weeks) and via AHT at two-week intervals in the home with respiratory therapist supervision for each subject/caregiver. Real-time respiratory data from subject’s smartphone was accessible on a dashboard for pulmonologist review and RedCap database download. Validity between conventional and portable spirometers and subject repeatability were completed. The random effects linear model analyzed eSVC/sSVC change.
Results:
Subjects (n=98): ALS diagnosis age (standard deviation [SD])=62.6 (10.4) years; disease duration (SD)=0.8 (1.8) years; ALSFRS-Rtotal (SD)=33.3 (7.6); eSVC baseline (SD)=72.6 (21.7) %predicted (%p); non-invasive ventilation (NIV)baseline=19; NIVstarted post-baseline=38; NIVnon-user=41. Most (72.5%) subjects completed ≥6 AHT. Monthly decline rate for eSVC (−1.75 %p/month, P<0.001) and sSVC (−1.12 %p/month, P<0.001) of NIV non-users was statistically significantly different from monthly decline rate for eSVC (−3.10 %p/month) and sSVC (−3.31 %p/month) for subjects who started NIV after baseline. Monthly decline rate for eSVC (−1.25 %p/month) and sSVC (−1.00 %p/month) for subjects on NIV at baseline was not statistically different from NIV non-users.
Conclusions:
This first implementation study of smartphone application-mediated AHT eSVC/sSVC measurement suggests statistically significant differences in monthly decline between NIV non-users and subjects on NIV at baseline vs subjects who started NIV post-baseline. Ongoing within-group analysis of the latter cohort of NIV adopters aims to determine when monthly decline rate decreases with NIV initiation.
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