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OpenTrials
Completed

NCT Number: NCT04095078

Ancillary Home Airway Clearance in CF Patients ( HomeCareSIMEOX )

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.

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Key information

Conditions

Pulmonary Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grenoble University Hospital : pneumo-pediatric department, Grenoble, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simeox

Device

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

Primary outcomes

  1. Pulmonary static hyperinflation assessed by residual volume

    Time frame: Change from baseline at 3 months

    Relative variation in Pulmonary residual volume in the SIMEOX® treated group versus control group.

Secondary outcomes

  1. Use assessed by the duration of use of SIMEOX® device

    Time frame: During 3 months of use

    Assess the duration of uses of the device SIMEOX by the patient in the SIMEOX® treated group to assess the use by patient of the device.

  2. Inspiratory capacity

    Time frame: Change from baseline at 3 months

    Relative variation of Inspiratory capacity in liter in the SIMEOX® treated group versus control group

  3. Residual functional capacity (RFC)

    Time frame: Change from baseline at 3 months

    Relative variation of Residual functional capacity (RFC) in liter in the SIMEOX® treated group versus control group

  4. Total lung capacity (TLC)

    Time frame: Change from baseline at 3 months

    Relative variation of Total lung capacity (TLC) in liter in the SIMEOX® treated group versus control group

Sponsors and collaborators

Lead sponsor

Physio-Assist

Industry

Collaborators

  • Icadom

Registry information

Official study title

Efficiency and Acceptability of SIMEOX® Used Autonomously at Home for Bronchial Clearance in Patients With Cystic Fibrosis: Ancillary Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 19, 2019
Registry last updated
Jan 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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