Validation of the "ExSpiron©" in Patients With ALS

NCT04089696 | Unknown

• 1 other identifier: UMCG
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

Non-invasive ventilation (NIV) in patients diagnosed with amyotrophic lateral sclerosis (ALS) is nowadays common practice to provide comfort at the end stage of the disease. As complaints vary there is the need of a non-invasive device to measure respiratory volume to objectify complaints. The ExSpiron© is a device for non-invasive monitoring of respiratory volume. The validation of this monitor in patients with ALS is the aim of this study. The hypothesis is that the ExSpiron© delivers a valid assessment of respiratory volume in patients with ALS

Conditions

Amyotrophic Lateral Sclerosis; Neuromuscular Diseases

Keywords

ALS

Outcome Measures

Primary Outcomes (1)

• The validity of the respiratory volumes (tidal volume and minute volume), compared tot the pneumotachometer.

  The validation of the ExSpiron© non-invasive monitor in patients diagnosed with ALS.

  1 year

Secondary Outcomes (4)

• The BORG RPE score (Ratings of Percieved Exertion)

  1 year

• The Amyotrophic lateral Sclerosis Assessment Questionnaire (ALSAQ-40)

  1 year

• SenTec is the name of a transcutaneous monitor

  1 year

• The EMG

  1 year

Study Arms (1)

ExSpiron

EXPERIMENTAL

10 patients with ALS

Device: ExSprion

Interventions

ExSprion DEVICE

The primary objective is the validation of the ExSpiron© non-invasive monitor in patients diagnosed with ALS.

ExSpiron

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• Participants diagnosed with ALS requiring NIV
• Age \> 18 of age; \< 85 years of age
• An indication to start chronic NIV, hypercapnic respiratory failure (arterial carbon dioxide PaCO2 \> 6.0 kilo pascal (kPa) measured during daytime) or orthopnoea due to diaphragm paralysis.
• Participants are able to provide feedback
• Participants that are willing to participate and are able to consent and sign the informed consent form.

You may not qualify if:

• A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Clinically unstable
• Acute respiratory failure
• Participants with refractory hypotension, defined as systolic blood pressure less than 90 mmHg, despite inotropic agents
• Uncontrolled cardiac ischemia or arrhythmias
• Participants suffering from metastatic or terminal cancer
• Other comorbid disease affecting respiration (ie obstructive sleep apnea, chronic obstructive pulmonary disease)
• Participants lacking functional medical decision-making

Sponsors & Collaborators

• University Medical Center Groningen: lead

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Peter Wijkstra, prof

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Wijkstra, prof

CONTACT

+31 50 3613200; p.j.wijsktra@umcg.nl

Anda Hazenberg, dr

CONTACT

+31 50 3613200; a.hazenberg@umcg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator P.J. Wijkstra

Model Details: Intervention study

Study Record Dates

• First Submitted: September 6, 2019
• First Posted: September 13, 2019
• Study Start: September 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: November 29, 2023

Record last verified: 2023-11