NHFT Effects on Symptatheic Drive of Asthma Patients (MSNA in Asthma)

January 26, 2026 updated by: RWTH Aachen University

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.

Study Overview

Status

Completed

Conditions

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:

  1. SNA is increased in asthma patients.
  2. NHFT has a positive impact on the sympathetic drive resulting in decreased SNA.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

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

Study Locations

  • Germany
    • North Rhine-Westphalia
      • Aachen, North Rhine-Westphalia, Germany, 52074
        • University Hospital RWTH Aachen-Department of Pneumology and Intensive Care

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

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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).

Description

Inclusion Criteria:

  • Clinically diagnosed Asthma
  • Age ≥ 18
  • Ability and willingness to give informed consent to participate in the study

Exclusion Criteria:

  • 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

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year
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).
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OSA severity
Time Frame: 1 year
Outcome measure: Apnea-hypopnea Index/h (AHI /h; Scale 0 - 150 /h with higher values indicating more severe sleep apnea).
1 year
Determination of PH (pulmonary hypertension) and right HF (heart failure) severity
Time Frame: 1 year
Outcome measure: TAPSE (tricuspid annular plane systolic excursion; mm).
1 year
Comprehensive lung function and inspiratory muscle function testing as previously described by our group
Time Frame: 1 year
Outcome measure: Sniff nasal pressure (SNIP; cmH2O).
1 year

Collaborators and Investigators

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

Sponsor

RWTH Aachen University

Collaborators

ResMed

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

July 1, 2023

Primary Completion (Actual)

June 1, 2025

Study Completion (Actual)

June 1, 2025

Study Registration Dates

First Submitted

January 6, 2023

First Submitted That Met QC Criteria

January 19, 2023

First Posted (Actual)

January 30, 2023

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTCA 22-274

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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