Respiratory DiseaseNCT05661019
Clinical Feasibility of the Myotrace Measurement
An observational study of Respiratory Disease, run by Philips Clinical & Medical Affairs Global at 1 site in Switzerland.
Trial summary
To evaluate the feasibility of the MYOTRACE NRD (Neural Respiratory Drive) index as an aid to assess the respiratory status of a patient (improving or stable versus deteriorating) as compared to a specialist in thoracic medicine's evaluation in a general care setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Disease
- What is being tested?
- Obtain Myotrace measurements
- How many people
- 56 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 May 2024to 9 Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: During recruitment of the patients, all patients admitted to the general ward who are having a respiratory disease or condition and satisfy the inclusion criteria will be eligible, including patients returning to general ward from ICU admission.
Who may be able to join
- Age 18+, fluent knowledge of English or German.
- Group A: Obstructive ventilatory disorders (conditions resulting in an increased load on the respiratory muscle pump due to hyperinflation ± pronounced hypoxaemia)
- Acute exacerbation of COPD (pronounced hypoxia OR acute or acute on chronic hypercapnic respiratory failure)
- Exacerbation of asthma bronchiale
- Exacerbation of non-CF-bronchiectasis (infectious)
- Infectious exacerbation of lung disease in cystic fibrosis
Show all 11Show fewer
- Group B: Conditions with an increase in NRD due to an impairment in gas exchange (particularly die to diffusion limitation and/or ventilation-perfusion-mismatch
- Exacerbation of an interstitial lung disease (e.g. Idiopathic pulmonary fibrosis (IPF), Non Specific Interstitial Pneumonia (NSIP), Connective tissue disease- associated interstitial lung disease CTD-ILD)
- Worsening of pulmonary arterial hypertension World Health Organisation (WHO) group 1 (e.g. due decompensated heart failure)
- Acute pulmonary embolism
- Pneumonia (resulting in hypoxaemia)
Who cannot join
- Obesity hypoventilation syndrome (rationale: NRD decreased)
- Obesity WHO III with Body Mass Index (BMI) > 40 kg/m2 (rationale: surface EMG signal quality low)
- Hypercapnic respiratory failure due to hypoventilation of central origin, e.g. opiate-induced, Congenital central hypoventilation syndrome, post stroke (rationale: central respiratory control affected)
- Neuromuscular disease affecting respiratory muscles, e.g. motor neurone disease, muscular dystrophy type Duchenne etc. (rationale: EMG signal quality etc. different)
- Decompensated heart failure with atrial fibrillation (rationale: central breathing disturbance common)
- Patients on chronic opioid therapy (e.g. chronic pain, methadone etc.) (rationale: reduced NRD)
- Self reported pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the feasibility of the MYOTRACE NRD (Neural Respiratory Drive) index as an aid to assess the respiratory status of a patient (improving or stable versus deteriorating) as compared to a specialist in thoracic medicine's evaluation in a general care setting.
Read the detailed description
This clinical investigation is designed as a single-arm evaluation of a diseased patient population. This study includes a longitudinal observation study of patients who enter the general ward (admission) until they leave the hospital (discharge).
This study includes standard patient care by the hospital staff with addition of Myotrace measurement, accelerometry and respiratory rate measurement via respiration belt during the NRD measurement.
The primary endpoint of the study is the Neural Respiratory Drive (NRD) index. This index will offline be compared to the specialist in thoracic medicine's assessment of the patient's health status after study closure. The General Ward care team will be blinded to the index values during the study. Re-admission information (i.e. 14 days after discharge) will be collected as well and used in the comparison with NRD index and specialist in thoracic medicine evaluation. Furthermore, the site will be asked to make note of patient events during study participation that are important for the study and study measurements.
The secondary endpoints of the study are the spot-check measurements, other objective and subjective measurements, and the subjective evaluation (e.g. experiences, preferences, acceptance, etc) of the Myotrace measurement protocol/procedures by the healthcare professionals and patients.
In total 50-60 patients will be enrolled.
- Conditions
- Respiratory Disease
- Being tested
- Obtain Myotrace measurements
- Medical subject headings
- Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obtain Myotrace measurementsOther
Myotrace measurement equipment, consisting of an application (i.e. non-medical software) running on a Philips laptop, Porti7 data acquisition system and software (Twente Medical Systems International (TMSi), Netherlands) (CE-approved), ECG cables, and three standard ECG (for EMG) electrodes. Also an on the shelf accelerometry sensor and respiration belt (TMSi) are used for the NRD measurement (CE-approved).
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate Feasibility of the MYOTRACE NRD index
to evaluate the feasibility of the MYOTRACE NRD index as an aid to assess the respiratory status of a patient as compared to a specialist in thoracic medicine's evaluation in a general care setting.
Measured: Mar 2024 (anticipated to be know at end of study)
Secondary outcomes (3)
Added value of NRD index
Investigate the added value of the NRD index on patient assessment, in comparison to the other spot-check measures
Measured: Mar 2024 (anticipated to be know at end of study)
Assess the viability of the MYOTRACE measurement protocol within the spot check practice
Assess the viability of the MYOTRACE measurement protocol within the spot check practice
Measured: Mar 2024 (anticipated to be know at end of study)
Healthcare/patient satisfaction
Level of healthcare professional as well as patient satisfaction, as captured via semi-quantitative and qualitative survey
Measured: Mar 2024 (anticipated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start15 May 2024
- Primary completion9 Jan 2025
- Study completion9 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DiseaseStudies of the same condition, open and under way.
- More trials run by Philips Clinical & Medical Affairs GlobalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Philips Medizin Systeme
- Responsible party
- Sponsor
- Investigators
- Dr. Schwarz, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661019
- Sponsor's protocol ID
- SEF-2023-300047 Myotrace
- Status last verified
- Dec 2025
- First submitted
- 13 Dec 2022
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will stay within Philips. A publication might occur with de-identified patient data.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Feasibility of the Myotrace Measurement
- ClinicalTrials.gov ID
- NCT05661019
- Acronym / sponsor ID
- SEF-2023-300047 Myotrace
- Conditions
- Respiratory Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Collaborators
- Philips Medizin Systeme
- Study start
- 15 May 2024 (actual)
- Primary completion
- 9 Jan 2025 (actual)
- Study completion
- 9 Jan 2025 (actual)
- First posted
- 22 Dec 2022 (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.
To evaluate the feasibility of the MYOTRACE NRD (Neural Respiratory Drive) index as an aid to assess the respiratory status of a patient (improving or stable versus deteriorating) as compared to a specialist in thoracic medicine's evaluation in a general care setting.
Detailed description
This clinical investigation is designed as a single-arm evaluation of a diseased patient population. This study includes a longitudinal observation study of patients who enter the general ward (admission) until they leave the hospital (discharge).
This study includes standard patient care by the hospital staff with addition of Myotrace measurement, accelerometry and respiratory rate measurement via respiration belt during the NRD measurement.
The primary endpoint of the study is the Neural Respiratory Drive (NRD) index. This index will offline be compared to the specialist in thoracic medicine's assessment of the patient's health status after study closure. The General Ward care team will be blinded to the index values during the study. Re-admission information (i.e. 14 days after discharge) will be collected as well and used in the comparison with NRD index and specialist in thoracic medicine evaluation. Furthermore, the site will be asked to make note of patient events during study participation that are important for the study and study measurements.
The secondary endpoints of the study are the spot-check measurements, other objective and subjective measurements, and the subjective evaluation (e.g. experiences, preferences, acceptance, etc) of the Myotrace measurement protocol/procedures by the healthcare professionals and patients.
In total 50-60 patients will be enrolled.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- During recruitment of the patients, all patients admitted to the general ward who are having a respiratory disease or condition and satisfy the inclusion criteria will be eligible, including patients returning to general ward from ICU admission.
Key inclusion criteria (11 listed)
- Age 18+, fluent knowledge of English or German.
- Group A: Obstructive ventilatory disorders (conditions resulting in an increased load on the respiratory muscle pump due to hyperinflation ± pronounced hypoxaemia)
- Group B: Conditions with an increase in NRD due to an impairment in gas exchange (particularly die to diffusion limitation and/or ventilation-perfusion-mismatch
Key exclusion criteria (7 listed)
- Obesity hypoventilation syndrome (rationale: NRD decreased)
- Obesity WHO III with Body Mass Index (BMI) > 40 kg/m2 (rationale: surface EMG signal quality low)
- Hypercapnic respiratory failure due to hypoventilation of central origin, e.g. opiate-induced, Congenital central hypoventilation syndrome, post stroke (rationale: central respiratory control affected)
- Neuromuscular disease affecting respiratory muscles, e.g. motor neurone disease, muscular dystrophy type Duchenne etc. (rationale: EMG signal quality etc. different)
- Decompensated heart failure with atrial fibrillation (rationale: central breathing disturbance common)
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 |
|---|---|---|
| Obtain Myotrace measurementsMyotrace measurement equipment, consisting of an application (i.e. non-medical software) running on a Philips laptop, Porti7 data acquisition system and software (Twente Medical Systems International (TMSi), Netherlands) (CE-approved), ECG cables, and three standard ECG (for EMG) electrodes. Also an on the shelf accelerometry sensor and respiration belt (TMSi) are used for the NRD measurement (CE-approved). | Other | – |
Primary outcome
Evaluate Feasibility of the MYOTRACE NRD index
Time frame: Mar 2024 (anticipated to be know at end of study)
to evaluate the feasibility of the MYOTRACE NRD index as an aid to assess the respiratory status of a patient as compared to a specialist in thoracic medicine's evaluation in a general care setting.
3 secondary outcomes
Added value of NRD index
Time frame: Mar 2024 (anticipated to be know at end of study)
Assess the viability of the MYOTRACE measurement protocol within the spot check practice
Time frame: Mar 2024 (anticipated to be know at end of study)
Healthcare/patient satisfaction
Time frame: Mar 2024 (anticipated)
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 9 Dec 2025.
- Individual participant dataSharing planned: No. All data will stay within Philips. A publication might occur with de-identified patient data.
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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.
Dr. Schwarz principal investigator
University of Zurich
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 Respiratory Disease, run by Philips Clinical & Medical Affairs Global at 1 site in Switzerland.
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 11 inclusion and 7 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 9 Dec 2025. 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 Switzerland. 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?
Evaluate Feasibility of the MYOTRACE NRD index (time frame: Mar 2024 (anticipated to be know at end of study)). 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 9 Dec 2025.