Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
143 participants
INTERVENTIONAL
2020-03-10
2025-03-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SIMEOX
Use the device for 3 months in addition to usual care
SIMEOX
Use without obligation, in autonomous and at home of the bronchial clearance device: SIMEOX
Control
Usual care
No interventions assigned to this group
Interventions
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SIMEOX
Use without obligation, in autonomous and at home of the bronchial clearance device: SIMEOX
Eligibility Criteria
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Inclusion Criteria
* Stabilization of the disease, defined by an at least 4 weeks period since the end of an exacerbation, stabilization will be let to investigator's judgment.
* Age \>12
* Requiring at least 1 bronchial clearing session each week (regardless of the technique)
* Patient (or patient's legal representative if applicable), capable to read and understand the procedure, and capable to express consent for the study protocol.
Exclusion Criteria
* Patient placed on a transplant waiting list
* Any contraindication to an instrumental bronchial clearance technique
* Patients already own and use SIMEOX at home
* Unavailable patient or patient wishing to move to a different region within three months after inclusion.
* Patient currently participating or having participated to another interventional clinical research within a month prior inclusion date, that may impact the study, this impact is left to the investigator's judgment.
* Persons referred by the French Public Health Code to Articles L1121-5 to L1121-8 (includes all protected persons: pregnant women (confirmed by measurement of the serum human chorionic gonadotropin level for any woman wishing to enter the protocol and under childbearing age \< 60), parturient woman, breastfeeding mother, everyone deprived of his liberty by judicial or administrative decision, everyone subject to a legal protection measure.
* Initiation of treatment with a CFTR modulator within the last 3 months
12 Years
ALL
No
Sponsors
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Icadom
INDUSTRY
Physio-Assist
INDUSTRY
Responsible Party
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Principal Investigators
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Rebecca Hamidfar, MD
Role: PRINCIPAL_INVESTIGATOR
CHUGA
Locations
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CHU Amiens Picardie
Amiens, , France
CHU Angers
Angers, , France
CHI Créteil
Créteil, , France
Grenoble University Hospital : pneumo-pediatric department
Grenoble, , France
Grenoble University-Affiliated Hospital : Pneumology department
Grenoble, , France
CHU Lyon HCL
Lyon, , France
Marseille University Hospital - Pneumology department
Marseille, , France
Montpellier Hospital Center
Montpellier, , France
Nice University-Affiliated Hospital : Pneumology department
Nice, , France
Nice University-Affiliated Hospital : Pneumo-pediatric department
Nice, , France
Hôpital Armand-Trousseau
Paris, , France
Hôpital Robert Debré
Paris, , France
CHU Reims
Reims, , France
Fondation Ildys
Roscoff, , France
CHU Felix Guyon
Saint-Denis, , France
CHU De la Réunion Site SUD - Pôle Femme-Mère-Enfant
Saint-Pierre, , France
CHU De la Réunion Site SUD
Saint-Pierre, , France
CHU Toulouse - Hôpital Larrey
Toulouse, , France
CHU Toulouse pediatric
Toulouse, , France
Groupement Hospitalier Brocéliande Atlantique
Vannes, , France
Countries
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Other Identifiers
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Home-Care SIMEOX®
Identifier Type: -
Identifier Source: org_study_id
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