Amyotrophic Lateral SclerosisNCT04089696
Validation of the "ExSpiron©" in Patients With ALS
A study testing ExSprion in people with Amyotrophic Lateral Sclerosis and Neuromuscular Diseases, run by University Medical Center Groningen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Neuromuscular Diseases
- What is being tested?
- ExSprion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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.
- Being tested
- ExSprion
- Keywords
- ALS
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExSprionDevice
The primary objective is the validation of the ExSpiron© non-invasive monitor in patients diagnosed with ALS.
| Study group | Role | What they receive |
|---|---|---|
| ExSpiron | Experimental | 10 patients with ALS Receives: Device: ExSprion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (4)
The BORG RPE score (Ratings of Percieved Exertion)
Visual analogue scale (VAS) score from 0-10, 0 is worse outcome, 10 is best outcome
Measured: 1 year
The Amyotrophic lateral Sclerosis Assessment Questionnaire (ALSAQ-40)
questionaire, score 0-4; 0 is never and 4 is always or can not do.
Measured: 1 year
SenTec is the name of a transcutaneous monitor
Gas exchange during the night with the transcutaneous monitor SenTec©
Measured: 1 year
The EMG
Respiratory muscle activity and patient-ventilator asynchrony during the night and during NIV assessed with surface electromyograph
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study startSep 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intervention study
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Wijkstra, University Medical Center Groningen
- Investigators
- Peter Wijkstra, prof, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04089696
- Sponsor's protocol ID
- UMCG
- Status last verified
- Nov 2023
- First submitted
- 6 Sep 2019
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the "Exspiron©" in Patients With Amyotrophic Lateral Sclerosis; Non-invasive Monitoring of Respiratory Volume.
- ClinicalTrials.gov ID
- NCT04089696
- Acronym / sponsor ID
- UMCG
- Keywords
- ALS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 13 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intervention study
| Arm | Type | Receives |
|---|---|---|
| ExSpiron | Experimental | Device: ExSprion10 patients with ALS |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExSprionThe primary objective is the validation of the ExSpiron© non-invasive monitor in patients diagnosed with ALS. | Device | ExSpiron |
Primary outcome
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.
4 secondary outcomes
The BORG RPE score (Ratings of Percieved Exertion)
Time frame: 1 year
The Amyotrophic lateral Sclerosis Assessment Questionnaire (ALSAQ-40)
Time frame: 1 year
SenTec is the name of a transcutaneous monitor
Time frame: 1 year
The EMG
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Wijkstra, prof principal investigator
University Medical Center Groningen
Questions about this trial
What is this clinical trial studying?
A study testing ExSprion in people with Amyotrophic Lateral Sclerosis and Neuromuscular Diseases, run by University Medical Center Groningen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Wijkstra, prof (+31 50 3613200, p.j.wijsktra@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The validity of the respiratory volumes (tidal volume and minute volume), compared tot the pneumotachometer. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.