Status:
NOT_YET_RECRUITING
Effectiveness of Gamified Mobile Health Apps for Airway Clearance Therapy in Children and Adolescents With Cystic Fibrosis
Lead Sponsor:
Universidad de Córdoba
Conditions:
Cystic Fibrosis (CF)
Eligibility:
All Genders
8-20 years
Phase:
NA
Brief Summary
The aim of this randomized controlled trial is to evaluate the effectiveness of gamified mobile health (mHealth) applications for airway clearance therapy in children and adolescents with cystic fibro...
Eligibility Criteria
Inclusion
- Population with cystic fibrosis (CF), aged 8-20 years.
- Individuals using or not using CFTR modulators (e.g., Kaftrio, Kalydeco, etc.), regardless of their specific mutation.
Exclusion
- Forced Vital Capacity (FVC) and/or Forced Expiratory Volume in the first second (FEV1) \< 40%.
- Oxygen therapy or continuous mechanical ventilation.
- Moderate hemoptysis or recent pneumothorax (within the past 3 months).
- Presence of an active, uncontrolled respiratory infection exacerbation that required hospitalization within the 30 days prior to the intervention.
- Other conditions such as neuromuscular disorders or cognitive difficulties (Mini-Mental State Examination score \< 19 points).
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06958094
Start Date
January 1 2026
End Date
January 1 2027
Last Update
May 8 2025
Active Locations (1)
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1
Asociación Andaluza de Fibrosis Quística
Seville, Seville, Spain, 41013