AsthmaMSNA in AsthmaNCT05704101
NHFT Effects on Symptatheic Drive of Asthma Patients
An observational study of Asthma, 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). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2023to 1 Jun 2025
- Phase
- Observational
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Asthma patients (n=20) and Controls (n=10) 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 2:1 ratio for age, sex and body mass index (BMI).
Who may be able to join
- Clinically diagnosed Asthma
- 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 or other pulmonary diseases (e.g. arterial hypertension, systolic heart failure, COPD)
- In-patient stay in the hospital within the last 4 weeks prior to the study examination date
- Severe polyneuropathy
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital RWTH Aachen-Department of Pneumology and Intensive Care
Aachen, North Rhine-Westphalia, 52074
About this study
Official title: Influence of Nasal High-flow Therapy (NHFT) on Ventilation and Sympathetic Drive in Patients With Asthma
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).
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 diseases as in chronic obstructive pulmonary disease (COPD) and pulmonary hypertension (PH). Comprehensive studies investigating sympathetic drive in Asthma as one of the major pulmonary diseases are still lacking. Furthermore, the intention of this study is to determine the impact of Nasal High Flow Therapy (NHFT) on SNA and assess respiratory muscle function using state-of-the-art techniques.
Read the detailed description
Asthma, being one of the major pulmonary diseases affects roughly 300 million people worldwide. This disease leads to airflow obstruction within the lung following chronic inflammation of the respiratory tract, which results in a wide range of symptoms. Overactivity of SNA has been already linked to patients with systolic heart failure and COPD. The investigators postulate that similar pathomechanism is prevalent in Asthma which leads to an overactivity of SNA.
Nasal High Flow Therapy (NHFT) is a recently developed form of oxygen therapy that delivers heated and humidified high-flow oxygen and gas mix through a nasal cannula. In comparison to conventional oxygen therapy, NHFT has been proven substantially beneficial due to additional effects like decreased oxygen dilution, increased FRC, dead space washout with CO2 removal, increased mucociliary function and generation of positive end-expiratory pressure (PEEP) which lead to significantly improved breathing mechanics often preventing the need for invasive machine ventilation (IMV) in various acute diseases. Furthermore, these mechanisms lead to the bronchodilation of small airways in primary obstructive pulmonary diseases like COPD. Positive benefits of NHFT, not only during an acute exacerbation but also with long-term stable disease have been already established in COPD. Similar effects could be expected in bronchial Asthma characterized by obstruction of small airways.
Thus, using a comprehensive, multimodal approach and state-of-the-art technology, this research project is designed to determine the prevalence, extent and nature of increased SNA in Asthma (AIM 1) and evaluate the impact of NHFT on sympathovagal balance in patients (AIM 2).
The project will address the following hypotheses:
- SNA is increased in asthma patients.
- NHFT has a positive impact on the sympathetic drive resulting in decreased SNA.
- Conditions
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asthma patients (n=20) out of them 10 with mild, controlled and 10 with severe, uncontrolled asthma | * Assessments of the SNA-axis. For this, HRV and dBPV will be analyzed using a 3-lead ECG and a continuous non-invasive arterial blood pressure signal. HRV and dBPV will be computed and presented as the high frequency , low frequency , their relative ratio (LF/HF), and the very low frequency component for both. * MSNA will be recorded via a tungsten microelectrode placed in the peroneal nerve. * NHFT at a flow rate of 20/30/40 liters/minute for 30 minutes respectively, with breaks of 15 minutes for all physiological variables to return to baseline. * OSA severity: defined as apnoea-hypopnoea index [AHI] >15/h and obstructive apnoea index [OAI] >5/h * Determination of PH and right HF severity (TAPSE ≤14 mm) and pulmonary arterial pressure (PAsys) using TTE. * Comprehensive lung function and inspiratory muscle strength and function testing as described previously by our group. * Assessment of systemic inflammation in blood samples. | |
| Controls (n=10) (and in a group of healthy controls [2:1] matched for age, sex and BMI). | * Assessments of the SNA-axis. For this, HRV and dBPV will be analyzed using a 3-lead ECG and a continuous non-invasive arterial blood pressure signal. HRV and dBPV will be computed and presented as the high frequency , low frequency , their relative ratio (LF/HF), and the very low frequency component for both. * MSNA will be recorded via a tungsten microelectrode placed in the peroneal nerve. * NHFT at a flow rate of 20/30/40 liters/minute for 30 minutes respectively, with breaks of 15 minutes for all physiological variables to return to baseline. * OSA severity: defined as apnoea-hypopnoea index [AHI] >15/h and obstructive apnoea index [OAI] >5/h * Determination of PH and right HF severity (TAPSE ≤14 mm) and pulmonary arterial pressure (PAsys) using TTE. * Comprehensive lung function and inspiratory muscle strength and function testing as described previously by our group. * Assessment of systemic inflammation in blood samples. |
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)
SVB (sympathovagal balance), HRV (Heart rate variability) and dBPV (diastolic blood pressure variability) 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 low frequency/high frequency (LF/HF), and the very low frequency component (VLF; 0.0-0.04 Hz) for both HRV and dBPV .
Outcome measure: LF/HF ratio of HRV.
Measured: 1 year
Assessments of the sympathetic nerve activity axis (Invasive)
MSNA will be recorded via a tungsten microelectrode carefully placed in the peroneal nerve.
Outcome measure: Burst Incidence (MSNA Bursts /100 beats).
Measured: 1 year
Secondary outcomes (3)
OSA severity
Outcome measure: Apnea-hypopnea Index/h (AHI /h; Scale 0 - 150 /h with higher values indicating more severe sleep apnea).
Measured: 1 year
Determination of PH (pulmonary hypertension) and right HF (heart failure) severity
Outcome measure: TAPSE (tricuspid annular plane systolic excursion; mm).
Measured: 1 year
Comprehensive lung function and inspiratory muscle function testing as previously described by our group
Outcome measure: Sniff nasal pressure (SNIP; cmH2O).
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 posted30 Jan 2023
- Study start1 Jul 2023
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- ResMed
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704101
- Sponsor's protocol ID
- CTCA 22-274
- Acronym
- MSNA in Asthma
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2023
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 31029769Dysart K, Miller TL, Wolfson MR, Shaffer TH. Research in high flow therapy: mechanisms of action. Respir Med. 2009 Oct;103(10):1400-5. doi: 10.1016/j.rmed.2009.04.007. Epub 2009 May 21.
PubMed 19467849Bruni A, Garofalo E, Cammarota G, Murabito P, Astuto M, Navalesi P, Luzza F, Abenavoli L, Longhini F. High Flow Through Nasal Cannula in Stable and Exacerbated Chronic Obstructive Pulmonary Disease Patients. Rev Recent Clin Trials. 2019;14(4):247-260. doi: 10.2174/1574887114666190710180540.
PubMed 31291880Garrard CS, Seidler A, McKibben A, McAlpine LE, Gordon D. Spectral analysis of heart rate variability in bronchial asthma. Clin Auton Res. 1992 Apr;2(2):105-11. doi: 10.1007/BF01819665.
PubMed 1638105
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
- Influence of Nasal High-flow Therapy (NHFT) on Ventilation and Sympathetic Drive in Patients With Asthma
- ClinicalTrials.gov ID
- NCT05704101
- Acronym / sponsor ID
- MSNA in Asthma / CTCA 22-274
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- ResMed
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 30 Jan 2023 (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).
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 diseases as in chronic obstructive pulmonary disease (COPD) and pulmonary hypertension (PH). Comprehensive studies investigating sympathetic drive in Asthma as one of the major pulmonary diseases are still lacking. Furthermore, the intention of this study is to determine the impact of Nasal High Flow Therapy (NHFT) on SNA and assess respiratory muscle function using state-of-the-art techniques.
Detailed description
Asthma, being one of the major pulmonary diseases affects roughly 300 million people worldwide. This disease leads to airflow obstruction within the lung following chronic inflammation of the respiratory tract, which results in a wide range of symptoms. Overactivity of SNA has been already linked to patients with systolic heart failure and COPD. The investigators postulate that similar pathomechanism is prevalent in Asthma which leads to an overactivity of SNA.
Nasal High Flow Therapy (NHFT) is a recently developed form of oxygen therapy that delivers heated and humidified high-flow oxygen and gas mix through a nasal cannula. In comparison to conventional oxygen therapy, NHFT has been proven substantially beneficial due to additional effects like decreased oxygen dilution, increased FRC, dead space washout with CO2 removal, increased mucociliary function and generation of positive end-expiratory pressure (PEEP) which lead to significantly improved breathing mechanics often preventing the need for invasive machine ventilation (IMV) in various acute diseases. Furthermore, these mechanisms lead to the bronchodilation of small airways in primary obstructive pulmonary diseases like COPD. Positive benefits of NHFT, not only during an acute exacerbation but also with long-term stable disease have been already established in COPD. Similar effects could be expected in bronchial Asthma characterized by obstruction of small airways.
Thus, using a comprehensive, multimodal approach and state-of-the-art technology, this research project is designed to determine the prevalence, extent and nature of increased SNA in Asthma (AIM 1) and evaluate the impact of NHFT on sympathovagal balance in patients (AIM 2).
The project will address the following hypotheses:
- SNA is increased in asthma patients.
- NHFT has a positive impact on the sympathetic drive resulting in decreased SNA.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma patients (n=20) out of them 10 with mild, controlled and 10 with severe, uncontrolled asthma | – | –* Assessments of the SNA-axis. For this, HRV and dBPV will be analyzed using a 3-lead ECG and a continuous non-invasive arterial blood pressure signal. HRV and dBPV will be computed and presented as the high frequency , low frequency , their relative ratio (LF/HF), and the very low frequency component for both. * MSNA will be recorded via a tungsten microelectrode placed in the peroneal nerve. * NHFT at a flow rate of 20/30/40 liters/minute for 30 minutes respectively, with breaks of 15 minutes for all physiological variables to return to baseline. * OSA severity: defined as apnoea-hypopnoea index [AHI] >15/h and obstructive apnoea index [OAI] >5/h * Determination of PH and right HF severity (TAPSE ≤14 mm) and pulmonary arterial pressure (PAsys) using TTE. * Comprehensive lung function and inspiratory muscle strength and function testing as described previously by our group. * Assessment of systemic inflammation in blood samples. |
| Controls (n=10) (and in a group of healthy controls [2:1] matched for age, sex and BMI). | – | –* Assessments of the SNA-axis. For this, HRV and dBPV will be analyzed using a 3-lead ECG and a continuous non-invasive arterial blood pressure signal. HRV and dBPV will be computed and presented as the high frequency , low frequency , their relative ratio (LF/HF), and the very low frequency component for both. * MSNA will be recorded via a tungsten microelectrode placed in the peroneal nerve. * NHFT at a flow rate of 20/30/40 liters/minute for 30 minutes respectively, with breaks of 15 minutes for all physiological variables to return to baseline. * OSA severity: defined as apnoea-hypopnoea index [AHI] >15/h and obstructive apnoea index [OAI] >5/h * Determination of PH and right HF severity (TAPSE ≤14 mm) and pulmonary arterial pressure (PAsys) using TTE. * Comprehensive lung function and inspiratory muscle strength and function testing as described previously by our group. * Assessment of systemic inflammation in blood samples. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Asthma patients (n=20) and Controls (n=10) 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 2:1 ratio for age, sex and body mass index (BMI).
Key inclusion criteria (3 listed)
- Clinically diagnosed Asthma
- Age ≥ 18
- Ability and willingness to give informed consent to participate in the study
Key exclusion criteria (5 listed)
- Atrial fibrillation
- Active pacing of the heart by a cardiac pacemaker (i.e. no intrinsic heart rate)
- Clinically pre-established cardiovascular disease or other pulmonary diseases (e.g. arterial hypertension, systolic heart failure, COPD)
- In-patient stay in the hospital within the last 4 weeks prior to the study examination date
- Severe polyneuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessments of the sympathetic nerve activity axis (Non invasive)
Time frame: 1 year
SVB (sympathovagal balance), HRV (Heart rate variability) and dBPV (diastolic blood pressure variability) 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 low frequency/high frequency (LF/HF), and the very low frequency component (VLF; 0.0-0.04 Hz) for both HRV and dBPV . Outcome measure: LF/HF ratio of HRV.
Assessments of the sympathetic nerve activity axis (Invasive)
Time frame: 1 year
MSNA will be recorded via a tungsten microelectrode carefully placed in the peroneal nerve. Outcome measure: Burst Incidence (MSNA Bursts /100 beats).
3 secondary outcomes
OSA severity
Time frame: 1 year
Determination of PH (pulmonary hypertension) and right HF (heart failure) severity
Time frame: 1 year
Comprehensive lung function and inspiratory muscle function testing as previously described by our group
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 19467849Dysart K, Miller TL, Wolfson MR, Shaffer TH. Research in high flow therapy: mechanisms of action. Respir Med. 2009 Oct;103(10):1400-5. doi: 10.1016/j.rmed.2009.04.007. Epub 2009 May 21.
- Background: PubMed 31291880Bruni A, Garofalo E, Cammarota G, Murabito P, Astuto M, Navalesi P, Luzza F, Abenavoli L, Longhini F. High Flow Through Nasal Cannula in Stable and Exacerbated Chronic Obstructive Pulmonary Disease Patients. Rev Recent Clin Trials. 2019;14(4):247-260. doi: 10.2174/1574887114666190710180540.
- Background: PubMed 1638105Garrard CS, Seidler A, McKibben A, McAlpine LE, Gordon D. Spectral analysis of heart rate variability in bronchial asthma. Clin Auton Res. 1992 Apr;2(2):105-11. doi: 10.1007/BF01819665.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Asthma, 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 3 inclusion and 5 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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: 1 year). 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 NCT05704101, which also lists 6 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.