Remote Pulmonary Function Testing in Amyotrophic Lateral Sclerosis (Pilot)

Completed · Not applicable

Conditions studied: ALS

In brief

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.

Key facts

Study ID

NCT03214224

Run by

Milton S. Hershey Medical Center

People needed

49

Starts

2017-11-01

Expected to finish

2019-09-30

Last updated by the study team

2020-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Part 1
• Patients:
• Possess a diagnosis of definite, probable, probable laboratory-supported, or possible ALS by revised El Escorial research criteria [Brooks2000].
• Be 18 years of age or older.
• Have a caregiver available to participate in the study
• Caregivers:
• Be 18 years of age or older, of either gender.
• Be able and willing to provide informed consent.
• Respiratory Therapist
• Be a member of the Hershey Medical Center ALS multidisciplinary care team.
• 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.
• Patients:
• Symptom onset within the last three years. 5) Have a computer and home internet service sufficient for engaging in telemedicine sessions.
• Have a second device capable of downloading the spirometer application from an app store (Android- or iOS-based smartphone or tablet).

You may not qualify if…

• Exclusion criteria are the same for both parts of the study.
• Patients:
• Use of NIV or diaphragm pacer at time of obtaining informed consent.
• FVC ≤50% predicted or MIP > -60 cm H2O.
• 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.
• Cognitive impairment, as judged by the ALS clinic neurologist, that prevents participation in the study.
• Caregivers: None
• Respiratory Therapists: None

Where it is running

• Hershey Medical Center ALS Clinic — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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