Study Purpose:The specific objective of this study is to validate the practice of remote pulmonary function testing (rPFT) conducted in the home through the use of connected mobile health devices and the Penn State Hershey ALS Telemanagement program.
Type of Intervention:
remote pulmonary function testing, standard pulmonary function testing
Study Chair(s)/Principal Investigator(s):
Coordinating Center Contact Information
Hershey, Pennsylvania, United States
Full Study Summary:
This is a self-controlled study which will enroll 40 patients from the ALS clinic. On the day of their clinical visit, study participants will perform both a standard PFT as well as a simulated rPFT, both generating three valid repetitions of forced vital capacity (FVC) and maximal inspiratory pressure (MIP) procedures. The simulated rPFT will mimic the practice of home telemonitoring by having patients be instructed by a respiratory therapist over the telemanagement portal while in a research room within the ALS clinic. The primary hypothesis is that there is no difference in the results of PFT and rPFT for respiratory assessment of FVC and MIP.
Milton S. Hershey Medical Center
Estimated Study Start Date:
11 / 01 / 2017
Estimated Study Completion Date:
09 / 30 / 2019
Posting Last Modified Date:
08 / 07 / 2020
Date Study Added to neals.org:
07 / 11 / 2017
Can participants use Riluzole?
- Part 1
1. Possess a diagnosis of definite, probable, probable laboratory-supported, or possible ALS by revised El Escorial research criteria [Brooks2000].
2. Be 18 years of age or older.
3. Have a caregiver available to participate in the study
1. Be 18 years of age or older, of either gender.
2. Be able and willing to provide informed consent.
1. Be a member of the Hershey Medical Center ALS multidisciplinary care team.
2. Be able and willing to provide verbal informed consent after receiving a summary explanation of research (SER).
Part 2 imposes additional inclusion criteria for patients only.
4) Symptom onset within the last three years. 5) Have a computer and home internet service sufﬁcient for engaging in telemedicine sessions.
6) Have a second device capable of downloading the spirometer application from an app store (Android- or iOS-based smartphone or tablet).
- Exclusion criteria are the same for both parts of the study.
1. Use of NIV or diaphragm pacer at time of obtaining informed consent.
2. FVC ≤50% predicted or MIP > -60 cm H2O.
3. ALS Functional Rating Scale (ALSFRS-R) [Cedarbaum1999] score on day of screening of ≥2 on items for speech, swallowing, and salivation. These items are indicators of bulbar dysfunction, which limits the reliability of PFT administration.
4. Cognitive impairment, as judged by the ALS clinic neurologist, that prevents participation in the study.
Respiratory Therapists: None
Hershey Medical Center ALS Clinic