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| Name | Class |
|---|---|
| Icadom | INDUSTRY |
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Regular bronchial clearance is essential in patients with cystic fibrosis for their bronchial health. SIMEOX® (Physio-Assist, Aix en Provence, France) is an innovative medical device for the drainage of the bronchial tree.
By changing the rheological properties of mucus, SIMEOX® helps to mobilize secretions and assists their transport to the upper airways. This technology is based on fundamental research on bronchial mucus rheology. At the present time, SIMEOX® device is mainly used over a short period at the time or after an exacerbation in healthcare structures (hospitals, physiotherapy practices, post-care, and rehabilitation units, etc…). The clinical effects observed in the short term encourages long-term autonomous use by the patients themselves.
The overall objective of this study is to evaluate the efficiency and acceptability of SIMEOX® used at home by the patient himself for bronchial clearance in patients with cystic fibrosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SIMEOX | Experimental | Use the device for 3 months in addition to usual care |
|
| Control | No Intervention | Usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIMEOX | Device | Use without obligation, in autonomous and at home of the bronchial clearance device: SIMEOX |
|
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory score of CFQ-R questionnaire | Relative variation in respiratory score of the CFQ-R questionnaire (Cystic Fibrosis Questionnaire -revised version) in the SIMEOX® treated group versus control group. Score range from 0 to 100, with higher score indicating better health. | Change from baseline at 3 months |
| Variation of forced expiratory volume in 1 second (FEV1) | Relative variation of the forced expiratory volume in 1 second (FEV1) in the SIMEOX® treated group versus control group | Change from baseline at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total score of CFQ-R questionnaire | Relative variation in the total score of the CFQ-R questionnaire (Cystic Fibrosis Questionnaire -revised version) in the SIMEOX® treated group versus control group.Score range from 0 to 100, with higher score indicating better health. | Change from baseline at 3 months |
| Safety of use assessed by incidence of Treatment-Emergent Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Hamidfar, MD | CHUGA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens Picardie | Amiens | 80054 | France | |||
| CHU Angers |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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Adaptive prospective, randomized, controlled, multicenter trial, with hierarchical sequential analysis.
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Take note and count all Treatment-Emergent Adverse Events to assess the safe use of SIMEOX® device autonomously at home |
| During 3 months of use |
| Satisfaction assessed by "Treatment Satisfaction Questionnaire for Medication"(TSQM) questionnaire | Total score into a value ranging from the worst satisfaction 0 to the best satisfaction 100 of the TSQM questionnaire in the SIMEOX® treated group to assess the satisfaction | After 3 months of use |
| Acceptability assessed by the number of uses of SIMEOX® device | Count the self-declared number of uses of the device SIMEOX by the patient in the SIMEOX® treated group to assess the acceptability of the device. | During 3 months of use |
| Pulmonary forced vital capacity (FVC) | Relative variation of forced vital capacity in liter in the SIMEOX® treated group versus control group. | Change from baseline at 3 months |
| FEV1/ FVC ratio | Relative variation of FEV1/ FVC ratio in % in the SIMEOX® treated group versus control group. | Change from baseline at 3 months |
| Forced expiratory flow | Relative variation of forced expiratory flow in liter per second in the SIMEOX® treated group versus control group | Change from baseline at 3 months |
| Static lung compliance in Liter | Relative variation of Static lung compliance in liter in the SIMEOX® treated group versus control group | Change from baseline at 3 months |
| Static lung compliance in % of predicted value | Relative variation of Static lung compliance in % of predicted value in the SIMEOX® treated group versus control group | Change from baseline at 3 months |
| Airway resistance | Relative variation of Airway resistance in cmH2O per liter per second in the SIMEOX® treated group versus control group | Change from baseline at 3 months |
| Diffusion capacity for carbon monoxide | Relative variation of Diffusion capacity for carbon monoxide in % in the SIMEOX® treated group versus control group | Change from baseline at 3 months |
| Quality of life assessed by EQ-5D 5L questionnaire : a standardized instrument for measuring generic health status | Relative variation of the scores of EQ-5D (a standardized instrument for measuring generic health status) questionnaire in the SIMEOX® treated group versus control group to asess the generic quality of life.Each 5 descriptive items have a value ranging from 1(best) to 5 (worst) and the visual analogic scale item should be scored from 0 (worst health) to 100 (best health). | Change from baseline at 3 months |
| Physical activity assessed by step counts and moderate-to-vigorous physical activity | Compare the effect of SIMEOX autonomous treatment at home versus usual care on step counts and moderate-to-vigorous physical activity measured by actigraph device | Change from baseline at 3 months |
| Sleep quality assessed by sleep efficiency and fragmentation | Compare the effect of SIMEOX autonomous treatment at home versus usual care on sleep efficiency and fragmentation measured by actigraph device | Change from baseline at 3 months |
| Fatigue assessed by VAS (visual analogue scale) | Compare the effect of SIMEOX autonomous treatment at home versus usual care on fatigue experienced after a drainage session assessed by the VAS score between 0 and 10 | During 3 months of use |
| Dyspnea assessed by mMRC (Modified Medical Research Council) score | Compare the effect of SIMEOX autonomous treatment at home versus usual care on mMRC (Modified Medical Research Council) score into a value ranging from the least severe dyspnea 0 to the most serious dyspnea 4 | Change from baseline at 3 months |
| Exacerbation rate | Compare the effect of SIMEOX autonomous treatment at home versus usual care on respiratory exacerbation rate | After 3 months of use |
| First exacerbation | Compare the effect of SIMEOX autonomous treatment at home versus usual care on the time to onset of the first exacerbation. | During 3 months of use |
| Hospitalization rate | Compare the effect of SIMEOX autonomous treatment at home versus usual care on hospitalization rate for respiratory exacerbation | After 3 months of use |
| Hospitalization duration | Compare the effect of SIMEOX autonomous treatment at home versus usual care on hospitalization duration for respiratory exacerbation | After 3 months of use |
| Antibiotic therapy | Compare the effect of SIMEOX autonomous treatment at home versus usual care on antibiotic therapy rate (intravenous or oral) | After 3 months of use |
| Adherence telemonitoring feasibility | Adherence telemonitoring feasibility is assessed by comparing self-declared data (number of treatment session) and electronically transmitted data. Electronically transmitted data will be transmitted by the SIMEOX-ANDROID application to an electronic secured platform. In the SIMEOX® treated group only. | After 3 months of use |
| Acceptability of SIMEOX-ANDROID application assessed by self-questionnaire AES (acceptability E-SCALE) | Total score into a value ranging from the worst acceptability 6 to the best acceptability 30 of the self-questionnaire AES (acceptability E-SCALE) in the SIMEOX® treated group to assess the SIMEOX-ANDROID application acceptability | After 3 months of use |
| Angers |
| 49993 |
| France |
| CHI Créteil | Créteil | 94000 | France |
| Grenoble University Hospital : pneumo-pediatric department | Grenoble | 38043 | France |
| Grenoble University-Affiliated Hospital : Pneumology department | Grenoble | 38043 | France |
| CHU Lyon HCL | Lyon | 69495 | France |
| Marseille University Hospital - Pneumology department | Marseille | 13005 | France |
| Montpellier Hospital Center | Montpellier | 34000 | France |
| Nice University-Affiliated Hospital : Pneumology department | Nice | 06002 | France |
| Nice University-Affiliated Hospital : Pneumo-pediatric department | Nice | 06200 | France |
| Hôpital Armand-Trousseau | Paris | 75012 | France |
| Hôpital Robert Debré | Paris | 75019 | France |
| CHU Reims | Reims | 51092 | France |
| Fondation Ildys | Roscoff | 29684 | France |
| CHU Felix Guyon | Saint-Denis | 97400 | France |
| CHU De la Réunion Site SUD - Pôle Femme-Mère-Enfant | Saint-Pierre | 97448 | France |
| CHU De la Réunion Site SUD | Saint-Pierre | 97448 | France |
| CHU Toulouse - Hôpital Larrey | Toulouse | 31059 | France |
| CHU Toulouse pediatric | Toulouse | 31059 | France |
| Groupement Hospitalier Brocéliande Atlantique | Vannes | 56017 | France |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |