Bronchiectasis AdultNCT04742270
Home Airway Clearance in Patients With Bronchiectasis (Home-Care Bronchiectasis)
A study testing SIMEOX+ respiratory physiotherapy telecare in people with Bronchiectasis Adult, run by Physio-Assist at 3 sites in France.
Trial summary
Bronchiectasis is a chronic multiple etiologies pulmonary disease characterized by permanent dilatation of the caliber of the bronchial tree territory with an alteration of mucociliary clearance. This alteration causes mucus retention and leads to infections and chronic bronchial inflammation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis Adult
- What is being tested?
- SIMEOX+ respiratory physiotherapy telecare
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 3 sitesFrance
- Study dates
- 4 Mar 2021to 31 Dec 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
- Patient with a diagnosis of bronchiectasis confirmed by HR CT scan, regardless of etiology except cystic fibrosis and with estimated bronchorrhea >10mL/d.
- Disease stability, defined as a delay of at least 4 weeks since the end of an exacerbation (end of antibiotic therapy or judged as resolved by the investigator).
- Age > 18 years old
- Patient does not have access to a physiotherapist or does not usually go to a physiotherapy office (<1/week on average)
Who cannot join
- Pneumothorax or severe hemoptysis (more than 30 ml per 24 hours) within 6 weeks before inclusion,
- Patient on transplant list
- Any contraindication to an instrumental bronchial clearance technique (at the discretion of the investigator)
- Patient not available or wishing to change of region within 3 months of inclusion
- Patient is currently participating or has participated within one month prior to inclusion in another clinical intervention research study that may impact the study, the impact of which is at the discretion of the investigator.
- Persons referred to in articles L1121-5 to L1121-8 of the CSP (corresponds to all protected persons: pregnant woman (verified by the dosage of β-HCG for any woman wishing to participate in the protocol and of childbearing age < 60 years), parturient, breastfeeding mother, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure)
Trial locations and contacts
3 sites in 1 country.
France3 sites
Grenoble University-Affiliated Hospital : Pneumology department
Grenoble, 38043
Nice university-affiliated hospital : pneumonoly department
Nice, 06001
Toulouse University-Affiliated Hospital : Pneumology department
Toulouse, 31030
About this study
Official title: Feasibility of Implementing SIMEOX® Using Tele-physiotherapy and Evaluation of Compliance With SIMEOX® at Home for Bronchial Drainage in Patients With Bronchiectasis Other Than Cystic Fibrosis and Who Have Difficulties in Accessing Regular Respiratory Physiotherapy Sessions.
Bronchiectasis is a chronic multiple etiologies pulmonary disease characterized by permanent dilatation of the caliber of the bronchial tree territory with an alteration of mucociliary clearance. This alteration causes mucus retention and leads to infections and chronic bronchial inflammation. Respiratory physiotherapy is one of the cornerstones of the management of these patients, particularly to facilitate bronchial drainage. In patients with abundant bronchial secretions, it is recommended to carry out airway clearance sessions daily or several times a day, which represents a very significant burden of care. Moreover, access to respiratory physiotherapy care isn't always easy for patients due to geographical, time, or professional availability limitations. In addition, few professionals are trained in France for this specific care dedicated to chronic lung disease. Finally with this kind of remote formation and follow up, it may be more suitable for this at-risk patient population in the context of the COVID-19 pandemic situation (limitation of physical contact).
SIMEOX® (Physio-Assist, Aix en Provence, France) is an innovative medical device (CE medical mark) for bronchial tree drainage. The use of this device in autonomy by the patient requires however a specific initial training of a few sessions (3-5 sessions). Tele-physiotherapy could allow remote training of patients in the use of SIMEOX®. This SIMEOX® device used autonomously at home, could provide patients with a practical and efficient bronchial clearance technique.
The overall objective of this pilot study is to evaluate the use of SIMEOX® at home after education in its use by telecare for bronchial drainage in patients with bronchiectasis (non-cystic Fibrosis Bronchiectasis) and who have difficulty accessing usual respiratory physiotherapy sessions.
Read the detailed description
Bronchiectasis is a chronic multiple etiologies pulmonary disease characterized by permanent and abnormal dilatation of the caliber of a territory of the bronchial tree with an alteration of mucociliary clearance. Patients with bronchiectasis have chronic cough and sputum production. Bacterial infections develop in them, leading to loss of lung function. Bronchiectasis affects patients of all ages and sexes, but the prevalence is higher in older women. It is often a complication of a previous lung infection or injury or is due to underlying systemic diseases. The treatment of bronchiectasis is multimodal and non-specific, including anti-inflammatory agents, bronchodilation, and depending on the clinical picture, bronchodilators, and inhaled antibiotics.
Respiratory physiotherapy is one of the cornerstones to facilitate bronchial drainage. In patients with abundant bronchial secretions, it is recommended that bronchial drainage sessions be performed daily or several times a day. These bronchial drainage sessions, whether performed with a physiotherapist or independently, represent a very significant burden of care with limited compliance. Moreover, access to respiratory physiotherapy care is not always easy for patients due to geographical, time or professional availability limitations. Telehealth is recommended to improve the access to care and the quality of care. The Article 53 of French Law No. 2019-774 of July 24, 2019, relating to the organization and transformation of the healthcare system, provides for telecare. In the context of respiratory physiotherapy, this is a session carried out remotely by the physiotherapist, by videotransmission. In the context of the COVID-19 health crisis, this telecare was regulated by the decree of May 11, 2020. The rehabilitation of respiratory diseases (excluding emergencies) was envisaged in this decree. Practical experiences of telecare in respiratory physiotherapy have emerged during this health crisis and have created an opportunity to facilitate access to care for patients.
The general principle expected from bronchial clearance techniques is to modify the viscoelastic properties of secretions and facilitate their elimination; these techniques can be applied simply with the spontaneous breathing of the patient by modifying the respiratory flow and/or the amplitude of ventilation or they can be applied with instrumental aids. SIMEOX® (Physio-Assist, Aix en Provence, France) is an innovative medical device (CE medical mark) for drainage of the bronchial tree: by means of a mouthpiece connected to SIMEOX® a succession of very short air negative pressure are generated in a non-invasive way that disseminate in the bronchial tree a pneumatic vibratory signal that modifies the rheological properties of the mucus, facilitates the mobilization of secretions and assists their transport to the upper airways. The SIMEOX® device was tested in patients with bronchiectasis during respiratory exacerbation during a 7-day hospital stay; patients reported good tolerance of the device; respiratory function and exercise tolerance parameters were improve. However, the patient's autonomous use of this device requires specific training of a few sessions (3 to 5 sessions).
RESEARCH HYPOTHESES Tele-physiotherapy could allow remote training of patients in the use of SIMEOX®. Once trained in its use, patients who have difficulty accessing standard respiratory physiotherapy sessions could be provided with a practical and effective bronchial clearance technique that can be used independently at home.
- Conditions
- Bronchiectasis Adult
- Being tested
- SIMEOX+ respiratory physiotherapy telecare
- Keywords
- Airway Clearance, Bronchiectasis, Respiratory Physiotherapy Telecare
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIMEOX+ respiratory physiotherapy telecareDevice
Every 10 days, the patient's expert physiotherapist will contact the patient by video-transmission or telephone call for motivational reinforcement and technical support in the use of the device.
During these phone calls, a quick 3-question questionnaire will be administered to the patient to monitor events of hemoptysis, chest pain and clinical symptoms of gastroesophageal reflux disease: pyrosis.If patients report this type of event, the physiotherapist will inform the patient's physician for management at his/her discretion.
The expert physiotherapist will also conduct this sessions in order to increase the patient's motivation and compliance to the device. In order to do this, he will identify (in collaboration with the patient), the patient's difficulties and obstacles and he will try to find solutions with him.
| Study group | Role | What they receive |
|---|---|---|
| SIMEOX+ respiratory physiotherapy telecare | Experimental | Use the device for 3 months in addition to usual care Receives: Device: SIMEOX+ respiratory physiotherapy telecare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance
The compliance with the SIMEOX® device at home is assessed by the change in the percentage of patient with an average of at least 3 sessions/week between D15 and 3 months (self-reported compliance by the patient on a diary)
Measured: 3 months after inclusion
Secondary outcomes (20)
Compliance reliability
Comparison of self-reported patient compliance to compliance reported on the "Simeox web application" web platform is assessed by the variation between the total number of sessions self-reported by the patient via a diary and the number of sessions found on the secure web platform "Simeox web application" between D15 and 3 months
Measured: 3 months after inclusion
Device use
The evolution of the use of the device (number of sessions self-reported by the patient) between D15 and 3 months will be described per week for all patients
Measured: 3 months after inclusion
Device satisfaction
Patient satisfaction with the SIMEOX device will be estimated using a visual analog scale from 0 for the worst satisfaction to 10 for the best satisfaction.
Measured: 3 months after inclusion
General compliance
Overall therapeutic adherence will be estimated by the BMQ questionnaire (Beliefs about Medecines Questionnaire) from 5 for the worst general compliance to 25 for the best general compliance.
Measured: At inclusion
Link between compliance to treatment and Physical activity
The link between treatment compliance and physical activity will be assessed by the IPAQ questionnaire (International Physical Activity Questionnaire). This questionnaire provides separate scores on sedentary, walking, moderate-intensity, and vigorous-intensity activity.
Measured: At inclusion and 3 months after
Poor compliance factors
To determine the factors associated with poor (self-reported) compliance with the SIMEOX® device.
Correlations between insufficient adherence (self-reported; <3 sessions/weeks between D15-D+3 months) to the SIMEOX® device and the following six factors will be sought (age, gender, marital status, socio-professional category, (8 INSEE posts https://www.insee.fr/fr/information/2400059), smoking status, number of drug treatments, severity of bronchiectasis (BSI Score -Bronchiectasia Severity Index), co-morbidities.
Measured: At inclusion
Sputum collection feasability
To evaluate the feasibility of a weekly collection by the patient of the quantity of bronchial secretions after a bronchial clearance session with SIMEOX®.
The feasibility of a weekly collection by the patient will be estimated by the frequency and weight of secretions reported on the patient's diary.
Measured: 3 months after inclusion
Quality of session
To assess the link between the quality of the session found on the web platform and the efficiency of bronchial clearance estimated by the frequency and weight of secretions reported on the patient's diary.
Measured: 3 months after inclusion
Tele-physiotherapy feasability
To evaluate the feasibility of one call every 10 days (reported by the patient in his or her diary) for therapeutic motivational reinforcement.
Measured: 3 months after inclusion
Specific quality of life
To evaluate the effect of SIMEOX®+ tele-physiotherapy on the specific quality of life of bronchiectasis after 3 months of home treatment.
The variation in quality of life will be measured by the change of the Qol-B questionnaire's score (total score and respiratory sub-scores, activity, social functioning, vitality, emotional function, constraints related to treatment) between inclusion and 3 months after inclusion.
Score range from 0 to 100, with higher score representing fewer symptoms or better functioning.
Measured: At inclusion and 3 months after
Global quality of life
Evaluate the effect of SIMEOX®+ tele-physiotherapy on the overall quality of life of respiratory diseases after 3 months of home treatment; The change in overall quality of life for respiratory diseases will be measured before and after 3 months of treatment using the Saint Georges Questionnaire (SGQOL).
Each response to the questionnaire is assigned a unique " value " derived from anterior data. The minimum weight is 0 and the highest is 100. For each component, sum the values assigned to each response. The score is calculated by dividing this sum of the values by the maximum possible score for each component and expressing the result as a percentage.
Measured: At inclusion and 3 months after
Cough perception
Evaluate the effect of SIMEOX®+ tele-physiotherapy on the perception of cough after 3 months of home treatment;The change in cough perception will be measured before and after 3 months of treatment with the Leicester questionnaire.
It consists of 19 items with a 7 point likert response scale (range from 1 to 7). Each item is developed to assess symptoms during cough and impact of cough on three main domains: physical, psychological and social. Scores are calculated as a mean of each domain and the total score is calculated by adding every domain score.
Measured: At inclusion and 3 months after
Bronchial clearance perception
Evaluate the effect of SIMEOX®+ tele-physiotherapy on the perception of bronchial congestion after 3 months of home treatment;The change in perception of bronchial congestion will be measured before and after 3 months of treatment by the Chronic Airways Assessment Test (CAT) questionnaire.
Score range from 0 to 40, with higher score representing better health.
Measured: At inclusion and 3 months after
Respiratory function :Variation of forced expiratory volume in 1 second (FEV1)
Evaluate the effect of SIMEOX®+ tele-physiotherapy on respiratory function after 3 months of home treatment on the forced expiratory volume in 1 second (FEV1)
Measured: At inclusion and 3 months after
Respiratory function :Pulmonary forced vital capacity (FVC)
Evaluate the effect of SIMEOX®+ tele-physiotherapy on respiratory function after 3 months of home treatment on relative variation of forced vital capacity in liter
Measured: At inclusion and 3 months after
Respiratory function :FEV1/ FVC ratio
Evaluate the effect of SIMEOX®+ tele-physiotherapy on respiratory function after 3 months of home treatment on relative variation of FEV1/ FVC ratio in %
Measured: At inclusion and 3 months after
Respiratory function : Forced Expiratory Flow (FEF)
Evaluate the effect of SIMEOX®+ tele-physiotherapy on respiratory function after 3 months of home treatment on relative variation of FEF in %
Measured: At inclusion and 3 months after
Exacerbation
Evaluate the effect of SIMEOX®+ tele-physiotherapy on the number of respiratory exacerbations; Respiratory exacerbations will be documented by the investigating physicians according to the EMBARC consensus definition.
Measured: 3 months after inclusion
First exacerbation onset
Evaluate the effect of SIMEOX®+ tele-physiotherapy on the time to onset of the first respiratory exacerbation.The date of consultation and/or hospitalization attesting to the exacerbation will be documented in the e-CRF to estimate the time to first exacerbation.
Measured: 3 months after inclusion
Adverse events
Adverse events and device causality will be monitored through a questionnaire of 4 items (hemoptysis, chest pain, gastro-esophageal reflux, other) during tele-physiotherapie sessions and eventual event will be collected in the eCRF
Measured: 3 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start4 Mar 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bronchiectasis AdultStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- There is no comparison procedure included in this feasibility trial. Patients will be their own control.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Physio-Assist
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Icadom
- Responsible party
- Sponsor
- Investigators
- Rebecca Hamidfar, MD, Principal investigator, Grenoble university affiliated hospital : pneumology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04742270
- Sponsor's protocol ID
- 2020-03
- Status last verified
- Jan 2022
- First submitted
- 26 Jan 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hamidfar R, Murris-Espin M, Mahot M, Abouly R, Gauchez H, Jacques S, Joffray E, Arnol N, Morin L, Leroy S, Borel JC. Feasibility of home initiation of an airway clearance device (SIMEOX) by telecare in people with non-cystic fibrosis bronchiectasis: a pilot study. BMJ Open Respir Res. 2023 Jul;10(1):e001722. doi: 10.1136/bmjresp-2023-001722.
PubMed 37524523
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Implementing SIMEOX® Using Tele-physiotherapy and Evaluation of Compliance With SIMEOX® at Home for Bronchial Drainage in Patients With Bronchiectasis Other Than Cystic Fibrosis and Who Have Difficulties in Accessing Regular Respiratory Physiotherapy Sessions.
- ClinicalTrials.gov ID
- NCT04742270
- Acronym / sponsor ID
- 2020-03
- Conditions
- Bronchiectasis Adult
- Keywords
- Airway Clearance, Bronchiectasis, Respiratory Physiotherapy Telecare
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Physio-AssistIndustry (pharma, biotech, devices)
- Collaborators
- Icadom
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 8 Feb 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.
Bronchiectasis is a chronic multiple etiologies pulmonary disease characterized by permanent dilatation of the caliber of the bronchial tree territory with an alteration of mucociliary clearance. This alteration causes mucus retention and leads to infections and chronic bronchial inflammation. Respiratory physiotherapy is one of the cornerstones of the management of these patients, particularly to facilitate bronchial drainage. In patients with abundant bronchial secretions, it is recommended to carry out airway clearance sessions daily or several times a day, which represents a very significant burden of care. Moreover, access to respiratory physiotherapy care isn't always easy for patients due to geographical, time, or professional availability limitations. In addition, few professionals are trained in France for this specific care dedicated to chronic lung disease. Finally with this kind of remote formation and follow up, it may be more suitable for this at-risk patient population in the context of the COVID-19 pandemic situation (limitation of physical contact).
SIMEOX® (Physio-Assist, Aix en Provence, France) is an innovative medical device (CE medical mark) for bronchial tree drainage. The use of this device in autonomy by the patient requires however a specific initial training of a few sessions (3-5 sessions). Tele-physiotherapy could allow remote training of patients in the use of SIMEOX®. This SIMEOX® device used autonomously at home, could provide patients with a practical and efficient bronchial clearance technique.
The overall objective of this pilot study is to evaluate the use of SIMEOX® at home after education in its use by telecare for bronchial drainage in patients with bronchiectasis (non-cystic Fibrosis Bronchiectasis) and who have difficulty accessing usual respiratory physiotherapy sessions.
Detailed description
Bronchiectasis is a chronic multiple etiologies pulmonary disease characterized by permanent and abnormal dilatation of the caliber of a territory of the bronchial tree with an alteration of mucociliary clearance. Patients with bronchiectasis have chronic cough and sputum production. Bacterial infections develop in them, leading to loss of lung function. Bronchiectasis affects patients of all ages and sexes, but the prevalence is higher in older women. It is often a complication of a previous lung infection or injury or is due to underlying systemic diseases. The treatment of bronchiectasis is multimodal and non-specific, including anti-inflammatory agents, bronchodilation, and depending on the clinical picture, bronchodilators, and inhaled antibiotics.
Respiratory physiotherapy is one of the cornerstones to facilitate bronchial drainage. In patients with abundant bronchial secretions, it is recommended that bronchial drainage sessions be performed daily or several times a day. These bronchial drainage sessions, whether performed with a physiotherapist or independently, represent a very significant burden of care with limited compliance. Moreover, access to respiratory physiotherapy care is not always easy for patients due to geographical, time or professional availability limitations. Telehealth is recommended to improve the access to care and the quality of care. The Article 53 of French Law No. 2019-774 of July 24, 2019, relating to the organization and transformation of the healthcare system, provides for telecare. In the context of respiratory physiotherapy, this is a session carried out remotely by the physiotherapist, by videotransmission. In the context of the COVID-19 health crisis, this telecare was regulated by the decree of May 11, 2020. The rehabilitation of respiratory diseases (excluding emergencies) was envisaged in this decree. Practical experiences of telecare in respiratory physiotherapy have emerged during this health crisis and have created an opportunity to facilitate access to care for patients.
The general principle expected from bronchial clearance techniques is to modify the viscoelastic properties of secretions and facilitate their elimination; these techniques can be applied simply with the spontaneous breathing of the patient by modifying the respiratory flow and/or the amplitude of ventilation or they can be applied with instrumental aids. SIMEOX® (Physio-Assist, Aix en Provence, France) is an innovative medical device (CE medical mark) for drainage of the bronchial tree: by means of a mouthpiece connected to SIMEOX® a succession of very short air negative pressure are generated in a non-invasive way that disseminate in the bronchial tree a pneumatic vibratory signal that modifies the rheological properties of the mucus, facilitates the mobilization of secretions and assists their transport to the upper airways. The SIMEOX® device was tested in patients with bronchiectasis during respiratory exacerbation during a 7-day hospital stay; patients reported good tolerance of the device; respiratory function and exercise tolerance parameters were improve. However, the patient's autonomous use of this device requires specific training of a few sessions (3 to 5 sessions).
RESEARCH HYPOTHESES Tele-physiotherapy could allow remote training of patients in the use of SIMEOX®. Once trained in its use, patients who have difficulty accessing standard respiratory physiotherapy sessions could be provided with a practical and effective bronchial clearance technique that can be used independently at home.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- There is no comparison procedure included in this feasibility trial. Patients will be their own control.
| Arm | Type | Receives |
|---|---|---|
| SIMEOX+ respiratory physiotherapy telecare | Experimental | Device: SIMEOX+ respiratory physiotherapy telecareUse the device for 3 months in addition to usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with a diagnosis of bronchiectasis confirmed by HR CT scan, regardless of etiology except cystic fibrosis and with estimated bronchorrhea >10mL/d.
- Disease stability, defined as a delay of at least 4 weeks since the end of an exacerbation (end of antibiotic therapy or judged as resolved by the investigator).
- Age > 18 years old
- Patient does not have access to a physiotherapist or does not usually go to a physiotherapy office (<1/week on average)
Key exclusion criteria (6 listed)
- Pneumothorax or severe hemoptysis (more than 30 ml per 24 hours) within 6 weeks before inclusion,
- Patient on transplant list
- Any contraindication to an instrumental bronchial clearance technique (at the discretion of the investigator)
- Patient not available or wishing to change of region within 3 months of inclusion
- Patient is currently participating or has participated within one month prior to inclusion in another clinical intervention research study that may impact the study, the impact of which is at the discretion of the investigator.
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 |
|---|---|---|
| SIMEOX+ respiratory physiotherapy telecareEvery 10 days, the patient's expert physiotherapist will contact the patient by video-transmission or telephone call for motivational reinforcement and technical support in the use of the device. During these phone calls, a quick 3-question questionnaire will be administered to the patient to monitor events of hemoptysis, chest pain and clinical symptoms of gastroesophageal reflux disease: pyrosis.If patients report this type of event, the physiotherapist will inform the patient's physician for management at his/her discretion. The expert physiotherapist will also conduct this sessions in order to increase the patient's motivation and compliance to the device. In order to do this, he will identify (in collaboration with the patient), the patient's difficulties and obstacles and he will try to find solutions with him. | Device | SIMEOX+ respiratory physiotherapy telecare |
Primary outcome
Compliance
Time frame: 3 months after inclusion
The compliance with the SIMEOX® device at home is assessed by the change in the percentage of patient with an average of at least 3 sessions/week between D15 and 3 months (self-reported compliance by the patient on a diary)
20 secondary outcomes
Compliance reliability
Time frame: 3 months after inclusion
Device use
Time frame: 3 months after inclusion
Device satisfaction
Time frame: 3 months after inclusion
General compliance
Time frame: At inclusion
Link between compliance to treatment and Physical activity
Time frame: At inclusion and 3 months after
Poor compliance factors
Time frame: At inclusion
Sputum collection feasability
Time frame: 3 months after inclusion
Quality of session
Time frame: 3 months after inclusion
Tele-physiotherapy feasability
Time frame: 3 months after inclusion
Specific quality of life
Time frame: At inclusion and 3 months after
Global quality of life
Time frame: At inclusion and 3 months after
Cough perception
Time frame: At inclusion and 3 months after
Bronchial clearance perception
Time frame: At inclusion and 3 months after
Respiratory function :Variation of forced expiratory volume in 1 second (FEV1)
Time frame: At inclusion and 3 months after
Respiratory function :Pulmonary forced vital capacity (FVC)
Time frame: At inclusion and 3 months after
Respiratory function :FEV1/ FVC ratio
Time frame: At inclusion and 3 months after
Respiratory function : Forced Expiratory Flow (FEF)
Time frame: At inclusion and 3 months after
Exacerbation
Time frame: 3 months after inclusion
First exacerbation onset
Time frame: 3 months after inclusion
Adverse events
Time frame: 3 months after inclusion
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 4 Jan 2022.
- Derived from this study: PubMed 37524523Hamidfar R, Murris-Espin M, Mahot M, Abouly R, Gauchez H, Jacques S, Joffray E, Arnol N, Morin L, Leroy S, Borel JC. Feasibility of home initiation of an airway clearance device (SIMEOX) by telecare in people with non-cystic fibrosis bronchiectasis: a pilot study. BMJ Open Respir Res. 2023 Jul;10(1):e001722. doi: 10.1136/bmjresp-2023-001722.
- 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.
Rebecca Hamidfar, MD principal investigator
Grenoble university affiliated hospital : pneumology department
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIMEOX+ respiratory physiotherapy telecare in people with Bronchiectasis Adult, run by Physio-Assist at 3 sites 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 4 inclusion and 6 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 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Compliance (time frame: 3 months after inclusion). 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 NCT04742270, which also lists 1 linked publication.
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 4 Jan 2022.