Digital Respiratory Comorbidity Detection with Wearable Device in PALS

Overview

About this study

The primary objective of the proposed study is to examine the feasibility of using digital technology to remotely collect data from people living with amyotrophic lateral sclerosis (PALS) for the purpose of

  1. Detecting the development of comorbid conditions, for possible earlier targeted intervention, and
  2. Quantifying functional decline for novel clinical trial outcome measure development and guiding clinical care.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • 18 years or older.
  • Capable of providing informed consent.
  • Able and willing to follow study procedures in the view of the investigator.
  • Confirmed diagnosis of ALS.
  • Qualify for non-invasive ventilation (NIV) AND have lower limb weakness impairing independent ambulation (i.e., requiring use of a cane, walker, wheelchair, etc., though not those who only require ankle-foot-orthotic (AFO) to ambulate).

Exclusion Criteria: 

  • Inability to comply with study procedures in the view of the investigator.
  • Current or planned use of therapeutic-level anticoagulation.
  • Symptomatic PE, DVT at enrollment.
  • Active respiratory disease.
  • Presence of unstable medical or psychiatric disease.
  • Pregnancy.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 9/28/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Stephen Johnson, M.D.

Open for enrollment

Contact information:

Alissa Bojko M.Ed.

(480) 301-4902

Bojko.Alissa@mayo.edu

More information

Publications

Publications are currently not available