CFDB - Cystic Fibrosis DataBase

ongoing trials trial from www.clinicaltrials.gov

Home Airway Clearance in CF Patients - Not yet recruiting

Study design (if review, criteria of inclusion for studies)

Interventional - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment

Participants

Pulmonary Cystic Fibrosis - 14 Years and older   (Child, Adult, Older Adult)

Interventions

Device: SIMEOX

Outcome measures

Respiratory score of CFQ-R questionnaire|Variation of forced expiratory volume in 1 second (FEV1)|Total score of CFQ-R questionnaire|Safety of use assessed by incidence of Treatment-Emergent Adverse Events|Satisfaction assessed by "Treatment Satisfaction Questionnaire for Medication"(TSQM) questionnaire|Acceptability assessed by the number of uses of SIMEOX® device|Pulmonary forced vital capacity (FVC)|FEV1/ FVC ratio|Forced expiratory flow|Total lung capacity (TLC)|Residual functional capacity (RFC)|Static lung compliance|Inspiratory capacity|Airway resistance|Diffusion capacity for carbon monoxide|Quality of life assessed by EQ-5D 5L questionnaire : a standardized instrument for measuring generic health status|Physical activity assessed by step counts and moderate-to-vigorous physical activity|Sleep quality assessed by sleep efficiency and fragmentation|Fatigue assessed by VAS (visual analogue scale)|Dyspnea assessed by mMRC (Modified Medical Research Council) score|Exacerbation rate|First exacerbation|Hospitalization rate|Hospitalization duration|Antibiotic therapy

Keywords: Airway clearance technique; Chest physiotherapy; non pharmacological intervention - devices OR physiotherapy; Home;