Validation of the "ExSpiron©" in Patients With ALS

November 28, 2023 updated by: Peter Wijkstra, University Medical Center Groningen

Validation of the "Exspiron©" in Patients With Amyotrophic Lateral Sclerosis; Non-invasive Monitoring of Respiratory Volume.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study design: This is an intervention study The validation of the ExSpiron© in patients diagnosed with ALS is done during admission on the Respiratory Care Unit (RCU) of the University Medical Center Groningen (UMCG). At daytime, tidal volume (TV) and minute volume (MV) will be measured during spontaneous breathing with the ExSpiron© simultaneously with a pneumotachometer (gold-standard). After installation of the chest pad of the ExSpiron© and the pneumotachometer, the first measurements are in sitting position. Three complete cycles of ten breaths; normal breathing, slow-deep breathing and rapid-shallow breathing, will be done. Between each cycle, a pause is allowed. After completing this breathing sequence, it is repeated in supine position. If patients are not able to perform this in supine position, because of orthopnea, an angle of 45º degree is adequate. After completing this cycle, the chest pad should be left in place and the electromyography (EMG) equipment should be installed. During the first night of admission, a full night of measurement of TV and MV will be conducted using the ExSpiron©.

Study population: 10 patients diagnosed with ALS and an indication to start NIV, >18 years of age.

Intervention (if applicable): The ExSpiron© is a device for non-invasive monitoring of tidal volumes and minute ventilation in non-intubated patients by using a disposable chest pad.

Main study parameters/endpoints: The main endpoint is the validation of the ExSpiron© in patients diagnosed with ALS and screened positive for starting NIV.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: NIV has no known serious side effects. ALS patients differ in starting NIV is done on the RCU while patients are monitored as standard care, the ExSpiron© is not an extra risk complaints but those screened positive to start NIV are not associated with risks. The intervention product, ExSpiron© is a non-invasive monitor with a chest pad attached to the patient.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ExSpiron
10 patients with ALS
Device: ExSprion
The primary objective is the validation of the ExSpiron© non-invasive monitor in patients diagnosed with ALS.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The validity of the respiratory volumes (tidal volume and minute volume), compared tot the pneumotachometer.
Time Frame: 1 year
The validation of the ExSpiron© non-invasive monitor in patients diagnosed with ALS.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The BORG RPE score (Ratings of Percieved Exertion)
Time Frame: 1 year
Visual analogue scale (VAS) score from 0-10, 0 is worse outcome, 10 is best outcome
1 year
The Amyotrophic lateral Sclerosis Assessment Questionnaire (ALSAQ-40)
Time Frame: 1 year
questionaire, score 0-4; 0 is never and 4 is always or can not do.
1 year
SenTec is the name of a transcutaneous monitor
Time Frame: 1 year
Gas exchange during the night with the transcutaneous monitor SenTec©
1 year
The EMG
Time Frame: 1 year
Respiratory muscle activity and patient-ventilator asynchrony during the night and during NIV assessed with surface electromyograph
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Medical Center Groningen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter Wijkstra, prof, UMCG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UMCG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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