COPDSNAP-COPDNCT04849806
Sympathetic Nerve Activity Predictors in Patients With Chronic Obstructive Pulmonary Disease
An observational study of COPD and Sympathetic Nervous System Diseases, run by RWTH Aachen University at 1 site in Germany.
Trial summary
The project will be pursued in our respiratory, autonomic nervous system physiology laboratory (Respiratory, autonomic nervous system physiology laboratory, Department of Pneumology and Intensive Care Medicine, RWTH Aachen University Hospital; Head of Department: Professor Michael Dreher). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD, Sympathetic Nervous System Diseases, Catecholamine; Overproduction
- What is being tested?
- Assessments of the sympathetic nerve activity axis, OSA severity and Determination of PH and right HF severity
- How many people
- 135 participants
- Where
- 1 siteGermany
- Study dates
- 10 May 2022to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: COPD patients (n=60) Controls (n=20) COPD patients without an established cardiovascular disease will be enrolled and the extent, nature and mechanism of SNA increase compared with healthy controls matched in a 3:1 ratio for age, sex and body mass index (BMI).
Who may be able to join
- Age ≥ 18
- Ability and willingness to give informed consent to participate in the study
Who cannot join
- Atrial fibrillation
- Active pacing of the heart by a cardiac pacemaker (i.e. no intrinsic heart rate)
- Clinically pre-established cardiovascular disease (e.g. arterial hypertension or systolic heart failure)
- In-patient stay in the hospital within the last 4 weeks prior to the study examination date
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
RWTH Aachen University
Aachen
Michael Dreher, Professor, +4924180 ext. 88763, mdreher@ukaachen.de
Jens Spiesshoefer, MD, +4924180 ext. 37036, jspiesshoefer@ukaachen.de
About this study
Official title: Dissecting the Nature and Determinants of Sympathetic Nerve Activity in Patients With COPD
The project will be pursued in our respiratory, autonomic nervous system physiology laboratory (Respiratory, autonomic nervous system physiology laboratory, Department of Pneumology and Intensive Care Medicine, RWTH Aachen University Hospital; Head of Department: Professor Michael Dreher).
Overactivity of the sympathetic nerve activity (SNA) axis with "centrally" increased heart rate and peripheral vasoconstriction is a known phenomenon in patients with systolic heart failure (HF) and has recently been described in patients with primary lung disease as seen in chronic obstructive pulmonary disease (COPD).
Read more
However, systematic analyses on this clinically relevant topic are currently lacking.
Thus, using a comprehensive, multimodal approach and state-of-the-art technology, this research project is designed to determine the extent and nature of increased SNA in COPD (AIM 1) and evaluate the underlying mechanisms (AIM 2).
The project will address the following hypotheses:
- In COPD, concomitant obstructive sleep apnea is independently associated with increased SNA.
- Precapillary pulmonary hypertension (PH), inspiratory muscle dysfunction and systemic inflammation describe a COPD phenotype characterised by increased SNA with a different subtype.
Read the detailed description
The project will be pursued in our respiratory, autonomic nervous system physiology laboratory (Respiratory, autonomic nervous system physiology laboratory, Department of Pneumology and Intensive Care Medicine, RWTH Aachen University Hospital; Head of Department: Professor Michael Dreher).
Overactivity of the sympathetic nerve activity (SNA) axis is a known phenomenon in patients with systolic heart failure (HF) and has recently been described in patients with primary lung disease as seen in chronic obstructive pulmonary disease (COPD).
Thus, insights into the nature of and factors involved in increased SNA in COPD are urgently needed.
Potentially obstructive sleep apnea (OSA) with not only repetitive obstructions but also additional hypoxia and poor sleep quality additively increase SNA in COPD. In addition, inspiratory muscle dysfunction (if adequately measured by magnetic diaphragm stimulation studies and comprehensive diaphragm ultrasound) with related hypercapnia, pulmonary hypertension (PH) and systemic inflammation all likely also impact on SNA in COPD.
However, systematic analyses on this clinically relevant topic are currently lacking.
Thus, using a comprehensive, multimodal approach and state-of-the-art technology, this research project is designed to determine the extent and nature of increased SNA in COPD (AIM 1) and evaluate the underlying mechanisms (AIM 2). The project will address the following hypotheses:
- In COPD, concomitant OSA with poor sleep is independently associated with increased SNA,.
- PH, inspiratory muscle dysfunction and systemic inflammation describe a COPD phenotype characterised by increased SNA, manifesting differently.
To test these hypotheses COPD patients without an established cardiovascular disease will be enrolled and the extent, nature and mechanism of SNA increase compared with healthy controls matched in a 3:1 ratio for age, sex and body mass index (BMI).
Invasive assessment of muscle SNA to the point of single unit recordings with analysis of single postganglionic sympathetic firing, and hence SNA drive to the peripheral vasculature, is the gold standard for quantification of SNA in humans but is only available in a few centres worldwide because it is costly, time consuming and requires a high level of training.
A small substudy will investigate the short term acute treatment effects of non-invasive ventilation and oxygen supplementation on SNA in patients with COPD.
- Being tested
- Assessments of the sympathetic nerve activity axis, OSA severity, Determination of PH and right HF severity, Comprehensive lung function and inspiratory muscle function testing., Assessment of systemic inflammation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Autonomic Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessments of the sympathetic nerve activity axisDiagnostic test
For assessment sympathovagal balance (SVB), HRV and dBPV will be analysed using a 3-lead electrocardiogram (sampling rate 1000Hz) and a continuous non-invasive arterial blood pressure signal (CNAP® technology, sampling rate 100Hz). HRV (ms2 based on continuously recorded variability in RR intervals) and (diastolic) BPV (expressed as mmHg2 based on continuously recorded variability in diastolic BP) will be computed by time domain analysis and by frequency domain analysis and presented as the high frequency component (HF; 0.15-0.4 Hz), low frequency component (LF; 0.04-0.15 Hz), their relative ratio (LF/HF), and the very low frequency component (VLF; 0.0-0.04 Hz) for both HRV and dBPV .
Muscle SNA will be recorded via a tungsten microelectrode carefully placed in the peroneal nerve. Plasma catecholamines will also be assessed.
OSA severityDiagnostic test
OSA is defined as apnoea-hypopnoea index [AHI] >15/h and obstructive apnoea index [OAI] >5/h) and sleep architecture
Determination of PH and right HF severityDiagnostic test
(defined as tricuspid annular plane systolic excursion ≤14 mm) and pulmonary arterial pressure (PAsys) using transthoracic echocardiography
Comprehensive lung function and inspiratory muscle function testing.Diagnostic test
Respiratory Muscle strength and function testing as previously established by our group and Assessment of daytime hypoxia (PaO2 <55 mmHg) and hypercapnia (PaCO2 >45 mmHg) using capillary blood gas analysis.
Assessment of systemic inflammationDiagnostic test
Based on blood samples taken.
| Study group | Role | What they receive |
|---|---|---|
| COPD patients (n=100) | The following parameters will be determined in 100 consecutive patients with COPD without established cardiovascular disease (i.e. without an indication for beta blocker therapy or other pharmacological treatments attacking on the neurohormonal pathways like angiotensin-converting enzyme inhibitors or mineralocorticoid receptor antagonists).
1. OSA severity.
2. Determination of PH and right HF severity (defined as tricuspid annular plane systolic excursion ≤14 mm) and pulmonary arterial pressure (PAsys) using transthoracic echocardiography;
3. Comprehensive lung function and inspiratory muscle function testing ;Assessment of daytime hypoxia (PaO2 <55 mmHg) and hypercapnia (PaCO2 >45 mmHg) using capillary blood gas analysis;
4. Assessment of systemic inflammation Receives: Diagnostic Test: Assessments of the sympathetic nerve activity axis; Diagnostic Test: OSA severity; Diagnostic Test: Determination of PH and right HF severity; Diagnostic Test: Comprehensive lung function and inspiratory muscle function testing.; Diagnostic Test: Assessment of systemic inflammation | |
| Controls (n=35) | (and in a group of healthy controls [3:1] matched for age, sex and BMI). Receives: Diagnostic Test: Assessments of the sympathetic nerve activity axis; Diagnostic Test: OSA severity; Diagnostic Test: Determination of PH and right HF severity; Diagnostic Test: Comprehensive lung function and inspiratory muscle function testing.; Diagnostic Test: Assessment of systemic inflammation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessments of the sympathetic nerve activity axis (Non invasive)
sympathovagal balance (SVB), HRV and dBPV will be analysed using a 3-lead electrocardiogram (sampling rate 1000Hz) and a continuous non-invasive arterial blood pressure signal (CNAP® technology, sampling rate 100Hz). HRV (ms2 based on continuously recorded variability in RR intervals) and (diastolic) BPV (expressed as mmHg2 based on continuously recorded variability in diastolic BP) will be computed by time domain analysis and by frequency domain analysis and presented as the high frequency component (HF; 0.15-0.4 Hz), low frequency component (LF; 0.04-0.15 Hz), their relative ratio (LF/HF), and the very low frequency component (VLF; 0.0-0.04 Hz) for both HRV and dBPV .
Measured: 2 years
Assessments of the sympathetic nerve activity axis (Invasive)
Muscle SNA will be recorded via a tungsten microelectrode carefully placed in the peroneal nerve Plasma catecholamines will be assessed Muscle SNA will be recorded via a tungsten microelectrode carefully placed in the peroneal nerve Plasma catecholamines will be assessed Muscle SNA will be recorded via a tungsten microelectrode carefully placed in the peroneal nerve. Plasma catecholamines will be assessed
Measured: 2 years
Secondary outcomes (4)
OSA severity
See above
Measured: 2 years
Determination of PH and right HF severity
See above
Measured: 2 years
Comprehensive lung function and inspiratory muscle function testing as previously described by our group
See above
Measured: 2 years
Assessment of systemic inflammation
See above
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start10 May 2022
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- DFG - Deutsche Forschungs Gemeinschaft (German Research Foundation)
- Responsible party
- Principal investigator, Jens Spießhöfer, RWTH Aachen University
- Investigators
- Michael Dreher, Professor, Study director, RWTH Aachen UniversityJens Spiesshoefer, MD, Principal investigator, RWTH Aachen UniversityBinaya Regmi, MD, Study chair, RWTH Aachen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04849806
- Sponsor's protocol ID
- CTCA 20-423
- Acronym
- SNAP-COPD
- Status last verified
- Jan 2026
- First submitted
- 15 Apr 2021
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Spiesshoefer J, Becker S, Tuleta I, Mohr M, Diller GP, Emdin M, Florian AR, Yilmaz A, Boentert M, Giannoni A. Impact of Simulated Hyperventilation and Periodic Breathing on Sympatho-Vagal Balance and Hemodynamics in Patients with and without Heart Failure. Respiration. 2019;98(6):482-494. doi: 10.1159/000502155. Epub 2019 Aug 28.
PubMed 31461730Spiesshoefer J, Herkenrath S, Henke C, Langenbruch L, Schneppe M, Randerath W, Young P, Brix T, Boentert M. Evaluation of Respiratory Muscle Strength and Diaphragm Ultrasound: Normative Values, Theoretical Considerations, and Practical Recommendations. Respiration. 2020;99(5):369-381. doi: 10.1159/000506016. Epub 2020 May 12.
PubMed 32396905Spiesshoefer J, Henke C, Herkenrath S, Brix T, Randerath W, Young P, Boentert M. Transdiapragmatic pressure and contractile properties of the diaphragm following magnetic stimulation. Respir Physiol Neurobiol. 2019 Aug;266:47-53. doi: 10.1016/j.resp.2019.04.011. Epub 2019 Apr 25.
PubMed 31029769Dreher M, Neuzeret PC, Windisch W, Martens D, Hoheisel G, Groschel A, Woehrle H, Fetsch T, Graml A, Kohnlein T. Prevalence Of Chronic Hypercapnia In Severe Chronic Obstructive Pulmonary Disease: Data From The HOmeVent Registry. Int J Chron Obstruct Pulmon Dis. 2019 Oct 18;14:2377-2384. doi: 10.2147/COPD.S222803. eCollection 2019.
PubMed 31695357
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissecting the Nature and Determinants of Sympathetic Nerve Activity in Patients With COPD
- ClinicalTrials.gov ID
- NCT04849806
- Acronym / sponsor ID
- SNAP-COPD / CTCA 20-423
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- DFG - Deutsche Forschungs Gemeinschaft (German Research Foundation)
- Study start
- 10 May 2022 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 19 Apr 2021 (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.
The project will be pursued in our respiratory, autonomic nervous system physiology laboratory (Respiratory, autonomic nervous system physiology laboratory, Department of Pneumology and Intensive Care Medicine, RWTH Aachen University Hospital; Head of Department: Professor Michael Dreher).
Overactivity of the sympathetic nerve activity (SNA) axis with "centrally" increased heart rate and peripheral vasoconstriction is a known phenomenon in patients with systolic heart failure (HF) and has recently been described in patients with primary lung disease as seen in chronic obstructive pulmonary disease (COPD).
However, systematic analyses on this clinically relevant topic are currently lacking.
Thus, using a comprehensive, multimodal approach and state-of-the-art technology, this research project is designed to determine the extent and nature of increased SNA in COPD (AIM 1) and evaluate the underlying mechanisms (AIM 2).
The project will address the following hypotheses:
- In COPD, concomitant obstructive sleep apnea is independently associated with increased SNA.
- Precapillary pulmonary hypertension (PH), inspiratory muscle dysfunction and systemic inflammation describe a COPD phenotype characterised by increased SNA with a different subtype.
Detailed description
The project will be pursued in our respiratory, autonomic nervous system physiology laboratory (Respiratory, autonomic nervous system physiology laboratory, Department of Pneumology and Intensive Care Medicine, RWTH Aachen University Hospital; Head of Department: Professor Michael Dreher).
Overactivity of the sympathetic nerve activity (SNA) axis is a known phenomenon in patients with systolic heart failure (HF) and has recently been described in patients with primary lung disease as seen in chronic obstructive pulmonary disease (COPD).
Thus, insights into the nature of and factors involved in increased SNA in COPD are urgently needed.
Potentially obstructive sleep apnea (OSA) with not only repetitive obstructions but also additional hypoxia and poor sleep quality additively increase SNA in COPD. In addition, inspiratory muscle dysfunction (if adequately measured by magnetic diaphragm stimulation studies and comprehensive diaphragm ultrasound) with related hypercapnia, pulmonary hypertension (PH) and systemic inflammation all likely also impact on SNA in COPD.
However, systematic analyses on this clinically relevant topic are currently lacking.
Thus, using a comprehensive, multimodal approach and state-of-the-art technology, this research project is designed to determine the extent and nature of increased SNA in COPD (AIM 1) and evaluate the underlying mechanisms (AIM 2). The project will address the following hypotheses:
- In COPD, concomitant OSA with poor sleep is independently associated with increased SNA,.
- PH, inspiratory muscle dysfunction and systemic inflammation describe a COPD phenotype characterised by increased SNA, manifesting differently.
To test these hypotheses COPD patients without an established cardiovascular disease will be enrolled and the extent, nature and mechanism of SNA increase compared with healthy controls matched in a 3:1 ratio for age, sex and body mass index (BMI).
Invasive assessment of muscle SNA to the point of single unit recordings with analysis of single postganglionic sympathetic firing, and hence SNA drive to the peripheral vasculature, is the gold standard for quantification of SNA in humans but is only available in a few centres worldwide because it is costly, time consuming and requires a high level of training.
A small substudy will investigate the short term acute treatment effects of non-invasive ventilation and oxygen supplementation on SNA in patients with COPD.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD patients (n=100) | – | Diagnostic Test: Assessments of the sympathetic nerve activity axis, Diagnostic Test: OSA severity, Diagnostic Test: Determination of PH and right HF severity, Diagnostic Test: Comprehensive lung function and inspiratory muscle function testing., Diagnostic Test: Assessment of systemic inflammationThe following parameters will be determined in 100 consecutive patients with COPD without established cardiovascular disease (i.e. without an indication for beta blocker therapy or other pharmacological treatments attacking on the neurohormonal pathways like angiotensin-converting enzyme inhibitors or mineralocorticoid receptor antagonists). 1. OSA severity. 2. Determination of PH and right HF severity (defined as tricuspid annular plane systolic excursion ≤14 mm) and pulmonary arterial pressure (PAsys) using transthoracic echocardiography; 3. Comprehensive lung function and inspiratory muscle function testing ;Assessment of daytime hypoxia (PaO2 <55 mmHg) and hypercapnia (PaCO2 >45 mmHg) using capillary blood gas analysis; 4. Assessment of systemic inflammation |
| Controls (n=35) | – | Diagnostic Test: Assessments of the sympathetic nerve activity axis, Diagnostic Test: OSA severity, Diagnostic Test: Determination of PH and right HF severity, Diagnostic Test: Comprehensive lung function and inspiratory muscle function testing., Diagnostic Test: Assessment of systemic inflammation(and in a group of healthy controls [3:1] matched for age, sex and BMI). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients (n=60) Controls (n=20) COPD patients without an established cardiovascular disease will be enrolled and the extent, nature and mechanism of SNA increase compared with healthy controls matched in a 3:1 ratio for age, sex and body mass index (BMI).
Key inclusion criteria (2 listed)
- Age ≥ 18
- Ability and willingness to give informed consent to participate in the study
Key exclusion criteria (4 listed)
- Atrial fibrillation
- Active pacing of the heart by a cardiac pacemaker (i.e. no intrinsic heart rate)
- Clinically pre-established cardiovascular disease (e.g. arterial hypertension or systolic heart failure)
- In-patient stay in the hospital within the last 4 weeks prior to the study examination date
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 |
|---|---|---|
| Assessments of the sympathetic nerve activity axisFor assessment sympathovagal balance (SVB), HRV and dBPV will be analysed using a 3-lead electrocardiogram (sampling rate 1000Hz) and a continuous non-invasive arterial blood pressure signal (CNAP® technology, sampling rate 100Hz). HRV (ms2 based on continuously recorded variability in RR intervals) and (diastolic) BPV (expressed as mmHg2 based on continuously recorded variability in diastolic BP) will be computed by time domain analysis and by frequency domain analysis and presented as the high frequency component (HF; 0.15-0.4 Hz), low frequency component (LF; 0.04-0.15 Hz), their relative ratio (LF/HF), and the very low frequency component (VLF; 0.0-0.04 Hz) for both HRV and dBPV . Muscle SNA will be recorded via a tungsten microelectrode carefully placed in the peroneal nerve. Plasma catecholamines will also be assessed. | Diagnostic test | COPD patients (n=100), Controls (n=35) |
| OSA severityOSA is defined as apnoea-hypopnoea index [AHI] >15/h and obstructive apnoea index [OAI] >5/h) and sleep architecture | Diagnostic test | COPD patients (n=100), Controls (n=35) |
| Determination of PH and right HF severity(defined as tricuspid annular plane systolic excursion ≤14 mm) and pulmonary arterial pressure (PAsys) using transthoracic echocardiography | Diagnostic test | COPD patients (n=100), Controls (n=35) |
| Comprehensive lung function and inspiratory muscle function testing.Respiratory Muscle strength and function testing as previously established by our group and Assessment of daytime hypoxia (PaO2 <55 mmHg) and hypercapnia (PaCO2 >45 mmHg) using capillary blood gas analysis. | Diagnostic test | COPD patients (n=100), Controls (n=35) |
| Assessment of systemic inflammationBased on blood samples taken. | Diagnostic test | COPD patients (n=100), Controls (n=35) |
Primary outcome
Assessments of the sympathetic nerve activity axis (Non invasive)
Time frame: 2 years
sympathovagal balance (SVB), HRV and dBPV will be analysed using a 3-lead electrocardiogram (sampling rate 1000Hz) and a continuous non-invasive arterial blood pressure signal (CNAP® technology, sampling rate 100Hz). HRV (ms2 based on continuously recorded variability in RR intervals) and (diastolic) BPV (expressed as mmHg2 based on continuously recorded variability in diastolic BP) will be computed by time domain analysis and by frequency domain analysis and presented as the high frequency component (HF; 0.15-0.4 Hz), low frequency component (LF; 0.04-0.15 Hz), their relative ratio (LF/HF), and the very low frequency component (VLF; 0.0-0.04 Hz) for both HRV and dBPV .
Assessments of the sympathetic nerve activity axis (Invasive)
Time frame: 2 years
Muscle SNA will be recorded via a tungsten microelectrode carefully placed in the peroneal nerve Plasma catecholamines will be assessed Muscle SNA will be recorded via a tungsten microelectrode carefully placed in the peroneal nerve Plasma catecholamines will be assessed Muscle SNA will be recorded via a tungsten microelectrode carefully placed in the peroneal nerve. Plasma catecholamines will be assessed
4 secondary outcomes
OSA severity
Time frame: 2 years
Determination of PH and right HF severity
Time frame: 2 years
Comprehensive lung function and inspiratory muscle function testing as previously described by our group
Time frame: 2 years
Assessment of systemic inflammation
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Background: PubMed 31461730Spiesshoefer J, Becker S, Tuleta I, Mohr M, Diller GP, Emdin M, Florian AR, Yilmaz A, Boentert M, Giannoni A. Impact of Simulated Hyperventilation and Periodic Breathing on Sympatho-Vagal Balance and Hemodynamics in Patients with and without Heart Failure. Respiration. 2019;98(6):482-494. doi: 10.1159/000502155. Epub 2019 Aug 28.
- Background: PubMed 32396905Spiesshoefer J, Herkenrath S, Henke C, Langenbruch L, Schneppe M, Randerath W, Young P, Brix T, Boentert M. Evaluation of Respiratory Muscle Strength and Diaphragm Ultrasound: Normative Values, Theoretical Considerations, and Practical Recommendations. Respiration. 2020;99(5):369-381. doi: 10.1159/000506016. Epub 2020 May 12.
- Background: PubMed 31029769Spiesshoefer J, Henke C, Herkenrath S, Brix T, Randerath W, Young P, Boentert M. Transdiapragmatic pressure and contractile properties of the diaphragm following magnetic stimulation. Respir Physiol Neurobiol. 2019 Aug;266:47-53. doi: 10.1016/j.resp.2019.04.011. Epub 2019 Apr 25.
- Background: PubMed 31695357Dreher M, Neuzeret PC, Windisch W, Martens D, Hoheisel G, Groschel A, Woehrle H, Fetsch T, Graml A, Kohnlein T. Prevalence Of Chronic Hypercapnia In Severe Chronic Obstructive Pulmonary Disease: Data From The HOmeVent Registry. Int J Chron Obstruct Pulmon Dis. 2019 Oct 18;14:2377-2384. doi: 10.2147/COPD.S222803. eCollection 2019.
- Individual participant dataSharing planned: Undecided
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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.
Michael Dreher, Professor study director
RWTH Aachen University
Jens Spiesshoefer, MD principal investigator
RWTH Aachen University
Binaya Regmi, MD study chair
RWTH Aachen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Sympathetic Nervous System Diseases, run by RWTH Aachen University at 1 site in Germany.
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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Dreher, Professor (+492418088763 ext. 88763, mdreher@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessments of the sympathetic nerve activity axis (Non invasive) (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04849806, which also lists 4 linked publications.
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 28 Jan 2026; AzTrials last refreshed its copy on 1 Nov 2026.