Ancillary Home Airway Clearance in CF Patients ( HomeCareSIMEOX )

NCT ID: NCT04095078

Last Updated: 2022-01-04

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-10

Study Completion Date

2021-12-15

Brief Summary

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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, postcare, 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.

Detailed Description

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Conditions

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Pulmonary Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomized, controlled, multicenter trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SIMEOX

Use the device for 3 months in addition to usual care

Group Type EXPERIMENTAL

SIMEOX

Intervention Type DEVICE

Use without obligation, in autonomous and at home of the bronchial clearance device: SIMEOX

Control

Usual care

Group Type NO_INTERVENTION

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* one of the 56 first patients of HOME-CARE SIMEOX study
* same criteria as HOME-CARE SIMEOX study

Exclusion Criteria

* same criteria as HOME-CARE SIMEOX study
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Icadom

INDUSTRY

Sponsor Role collaborator

Physio-Assist

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boubou Camara, MD

Role: PRINCIPAL_INVESTIGATOR

CHUGA

Locations

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Grenoble University Hospital : pneumo-pediatric department

Grenoble, , France

Site Status

Grenoble University-Affiliated Hospital : Pneumology department

Grenoble, , France

Site Status

Montpellier Hospital Center

Montpellier, , France

Site Status

Nice University-Affiliated Hospital : Pneumology department

Nice, , France

Site Status

Nice University-Affiliated Hospital : Pneumo-pediatric department

Nice, , France

Site Status

Countries

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France

Other Identifiers

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Ancillary Home-Care SIMEOX

Identifier Type: -

Identifier Source: org_study_id

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