Systemic SclerosisSIROCONCT04118725
Muscular Respiratory Involvement and Systemic Sclerosis
A study testing Pulmonary function test in people with Systemic Sclerosis and Diaphragm Defect, run by Poitiers University Hospital at 1 site in France.
Trial summary
Dyspnea in systemic sclerosis (ScS) constitute a major factor of functional disability. Intensity of dyspnea is sometimes discordant with objectives data from cardiopulmonary involvements, suggesting unknown additional factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis, Diaphragm Defect, Respiratory Insufficiency
- What is being tested?
- Pulmonary function test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 21 Oct 2019to 7 Jul 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years-old
- ScS fulfilling ACR/EULAR 2013 classification criteria and followed in the department of internal medicine of Poitiers University Hospital
- Written informatory consent
Who cannot join
- Individuals under tutorship or guardianship
- Individuals with reinforced protection: minors, judiciary or administrative decision
- No affiliation to social insurance
- Pregnancy or breastfeeding
- Associated neuromuscular disease (myasthenia, degenerative diseases)
- Bedridden individuals or with health condition not allowing realization or interpretation of PFT and/or EMG (acute cardiac and/or respiratory failure, pneumopathy)
- Individuals with pacemaker and implanted pumps, especially sensing dispositives, as defibrillators ( relative contre-indication to EMG with magnetic stimulation)
- Individuals with contre-indication to gastroesophageal probe: INR >4, oesophageal varices, suspected cardio-facial fracture, oesophageal and/or facial obstacle
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Muscular Respiratory Involvement in Systemic Sclerosis
Dyspnea in systemic sclerosis (ScS) constitute a major factor of functional disability.
Intensity of dyspnea is sometimes discordant with objectives data from cardiopulmonary involvements, suggesting unknown additional factors.
Read more
Diffuse fibrosing myopathy of bad prognosis have been reported in ScS.To now, muscular respiratory involvement has not been evaluated in ScS. Therefore, ScS patients (with or without dyspnea) could have underlying respiratory muscular involvement not detected by current standard of care with pulmonary function tests (PFT).
This project is the first, to the best of our knowledge, to assess frequency of respiratory muscular involvement in ScS and to evaluate a screening strategy of this involvement.
- Conditions
- Systemic Sclerosis, Diaphragm Defect, Respiratory Insufficiency, Pulmonary Function Test, Diaphragmatic Electromyography, Muscular Weakness
- Being tested
- Pulmonary function test
- Medical subject headings
- Scleroderma, Systemic, Respiratory Insufficiency, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary function testDiagnostic test
Diaphragmatic electromyography with measurement of transdiaphragmatic pressure in cases of dyspnea and/or abnormal pulmonary function test (maximum inspiratory pressure and/or lying/seating low vital capacity ratio)
| Study group | Role | What they receive |
|---|---|---|
| Muscular explorations | Experimental | Pulmonary function test and diaphragmatic electromyography Receives: Diagnostic Test: Pulmonary function test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of diaphragmatic involvement among ScS patients with dyspnea and/or with suspected respiratory muscular involvement on pulmonary function tests (PFT)
Number of patients with dyspnea (SADOUL ≥2) and/or with respiratory muscular involvement suspected on PFT (maximum inspiratory pressure (max IP) below definite z-score and/or lying/sitting low vital capacity (LVC) ratio < 75%) having diaphragmatic muscular involvement confirmed by diaphragmatic electromyography (EMG) (latency >8.5ms and amplitudes <0.5mV) by neck electric phrenic stimulation and/or Pdi <20cmH2O after magnetic stimulation
Measured: 4 months maximum (maximum time between PFT realization and date to obtain EMG/Pdi)
Secondary outcomes (6)
Sensitivity, specificity, positive and negative predictive value of pulmonary function tests compared to diaphragmatic involvement confirmed by EMG and Pdi among ScS patients with suspected pulmonary muscular involvement on PFT
Proportion of ScS patients with diaphragmatic involvement confirmed by EMG (latency >8.5ms and amplitudes <0.5mV by neck electric phrenic stimulation and/or Pdi <20cmH2O after magnetic stimulation) compared to proportion of ScS patients with maxIP below definite z-score and/or lying/sitting LVC ratio <75%
Measured: 4 months maximum (maximum time between PFT realization and date to obtain EMG/Pdi)
Sensitivity, specificity, positive and negative predictive value of dyspnea compared to diaphragmatic involvement confirmed by EMG and Pdi
Proportion of ScS patients with diaphragmatic involvement confirmed by EMG (latency >8.5ms and amplitudes <0.5mV by neck electric phrenic stimulation and/or Pdi <20cmH2O after magnetic stimulation) compared to proportion of ScS patients with dyspnea (SADOUL ≥2) or without dyspnea
Measured: 4 months maximum (maximum time between PFT realization and date to obtain EMG/Pdi)
Correlation between diaphragmatic involvement confirmed by EMG and and/or Pdi and dyspnea
Proportion of ScS patients with diaphragmatic involvement confirmed by EMG (latency >8.5ms and amplitudes <0.5mV by neck electric phrenic stimulation and/or Pdi <20cmH2O after magnetic stimulation) and proportion of ScS patients with dyspnea (SADOUL ≥2)
Measured: 4 months maximum (maximum time between PFT realization and date to obtain EMG/Pdi)
Correlation between diaphragmatic involvement confirmed by EMG and and/or Pdi and general and ScS-related factors
Proportion of ScS patients with diaphragmatic involvement confirmed by EMG (latency >8.5ms and amplitudes <0.5mV by neck electric phrenic stimulation and/or Pdi <20cmH2O after magnetic stimulation) and : age in years ; proportion of female; proportion of limited cutaneous or diffuse cutaneous or sine scleroderma ; ScS duration in years, proportion of anti-centromere or anti-Scl70 or anti-ARNpolymeraseIII or "others" autoantibody; proportion of digital tip ulcerations; proportion of subcutaneous calcifications; proportion of arthritis; proportion of arterial pulmonary hypertension; proportion of interstitial lung disease; proportion of renal crisis; proportion of inflammatory myopathy; proportion of immunosuppressant use; modified Rodnan skin score (median, ranging from 0-51)); interlabial length in centimeter; proportion of telangiectasia; proportion of cardiac insufficiency (left and/or right heart); creatine phosphokinase level in UI/mL ; PO2 in mmHg; PCO2 in mmHg
Measured: 4 months maximum (maximum time between PFT realization and date to obtain EMG/Pdi)
Correlation between diaphragmatic involvement confirmed by EMG and and/or Pdi and suspected muscular respiratory on pulmonary function test
Proportion of ScS patients with diaphragmatic involvement confirmed by EMG (latency >8.5ms and amplitudes <0.5mV by neck electric phrenic stimulation and/or Pdi <20cmH2O after magnetic stimulation) and proportion of patients with maxIP below definite z-score and/or lying/sitting LVC ratio < 75%)
Measured: 4 months maximum (maximum time between PFT realization and date to obtain EMG/Pdi)
Correlation between diaphragmatic involvement confirmed by EMG and and/or Pdi and quality of life and functional disability
Proportion of ScS patients with diaphragmatic involvement confirmed by EMG (latency >8.5ms and amplitudes <0.5mV by neck electric phrenic stimulation and/or Pdi <20cmH2O after magnetic stimulation) and total score in the Functional Assessment of Chronic Illness Therapy (FACIT)-Dyspnea-short form (ranging from 0 to 30; higher values represent a worse outcome); physical summary score (mean) from the short form health survey 36 (SF-36) (French version 2.0) ranging from 0 to 100 (higher values represent a worse outcome) ; mental summary score (mean) from the short form health survey 36 (SF-36) (French version 2.0) ranging from 0 to 100 (higher values represent a worse outcome
Measured: 4 months maximum (maximum time between PFT realization and date to obtain EMG/Pdi)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start21 Oct 2019
- Primary completion7 Jul 2021
- Study completion7 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118725
- Sponsor's protocol ID
- 2019-A01047-50
- Acronym
- SIROCO
- Status last verified
- Sep 2021
- First submitted
- 26 Sep 2019
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Muscular Respiratory Involvement in Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT04118725
- Acronym / sponsor ID
- SIROCO / 2019-A01047-50
- Conditions
- Systemic Sclerosis, Diaphragm Defect, Respiratory Insufficiency, Pulmonary Function Test, Diaphragmatic Electromyography, Muscular Weakness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 7 Jul 2021 (actual)
- Study completion
- 7 Jul 2021 (actual)
- First posted
- 8 Oct 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.
Dyspnea in systemic sclerosis (ScS) constitute a major factor of functional disability.
Intensity of dyspnea is sometimes discordant with objectives data from cardiopulmonary involvements, suggesting unknown additional factors.
Diffuse fibrosing myopathy of bad prognosis have been reported in ScS.To now, muscular respiratory involvement has not been evaluated in ScS. Therefore, ScS patients (with or without dyspnea) could have underlying respiratory muscular involvement not detected by current standard of care with pulmonary function tests (PFT).
This project is the first, to the best of our knowledge, to assess frequency of respiratory muscular involvement in ScS and to evaluate a screening strategy of this involvement.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Muscular explorations | Experimental | Diagnostic Test: Pulmonary function testPulmonary function test and diaphragmatic electromyography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years-old
- ScS fulfilling ACR/EULAR 2013 classification criteria and followed in the department of internal medicine of Poitiers University Hospital
- Written informatory consent
Key exclusion criteria (8 listed)
- Individuals under tutorship or guardianship
- Individuals with reinforced protection: minors, judiciary or administrative decision
- No affiliation to social insurance
- Pregnancy or breastfeeding
- Associated neuromuscular disease (myasthenia, degenerative diseases)
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 |
|---|---|---|
| Pulmonary function testDiaphragmatic electromyography with measurement of transdiaphragmatic pressure in cases of dyspnea and/or abnormal pulmonary function test (maximum inspiratory pressure and/or lying/seating low vital capacity ratio) | Diagnostic test | Muscular explorations |
Primary outcome
Frequency of diaphragmatic involvement among ScS patients with dyspnea and/or with suspected respiratory muscular involvement on pulmonary function tests (PFT)
Time frame: 4 months maximum (maximum time between PFT realization and date to obtain EMG/Pdi)
Number of patients with dyspnea (SADOUL ≥2) and/or with respiratory muscular involvement suspected on PFT (maximum inspiratory pressure (max IP) below definite z-score and/or lying/sitting low vital capacity (LVC) ratio < 75%) having diaphragmatic muscular involvement confirmed by diaphragmatic electromyography (EMG) (latency >8.5ms and amplitudes <0.5mV) by neck electric phrenic stimulation and/or Pdi <20cmH2O after magnetic stimulation
6 secondary outcomes
Sensitivity, specificity, positive and negative predictive value of pulmonary function tests compared to diaphragmatic involvement confirmed by EMG and Pdi among ScS patients with suspected pulmonary muscular involvement on PFT
Time frame: 4 months maximum (maximum time between PFT realization and date to obtain EMG/Pdi)
Sensitivity, specificity, positive and negative predictive value of dyspnea compared to diaphragmatic involvement confirmed by EMG and Pdi
Time frame: 4 months maximum (maximum time between PFT realization and date to obtain EMG/Pdi)
Correlation between diaphragmatic involvement confirmed by EMG and and/or Pdi and dyspnea
Time frame: 4 months maximum (maximum time between PFT realization and date to obtain EMG/Pdi)
Correlation between diaphragmatic involvement confirmed by EMG and and/or Pdi and general and ScS-related factors
Time frame: 4 months maximum (maximum time between PFT realization and date to obtain EMG/Pdi)
Correlation between diaphragmatic involvement confirmed by EMG and and/or Pdi and suspected muscular respiratory on pulmonary function test
Time frame: 4 months maximum (maximum time between PFT realization and date to obtain EMG/Pdi)
Correlation between diaphragmatic involvement confirmed by EMG and and/or Pdi and quality of life and functional disability
Time frame: 4 months maximum (maximum time between PFT realization and date to obtain EMG/Pdi)
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 29 Sep 2021.
- 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. 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?
A study testing Pulmonary function test in people with Systemic Sclerosis and Diaphragm Defect, run by Poitiers University Hospital at 1 site in France.
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 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: finished, as of the sponsor's last update on 29 Sep 2021. 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 France. 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?
Frequency of diaphragmatic involvement among ScS patients with dyspnea and/or with suspected respiratory muscular involvement on pulmonary function tests (PFT) (time frame: 4 months maximum (maximum time between PFT realization and date to obtain EMG/Pdi)). 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 Sep 2021.