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Tests game-style phone apps for airway clearance in children with cystic fibrosis

Tests game-based phone apps for clearing airways in children and teens with cystic fibrosis.

Plain-language title generated from the registry record
Registry title: Effectiveness of Gamified Mobile Health Apps for Airway Clearance Therapy in Children and Adolescents With Cystic Fibrosis

Key facts

Where
Seville, SpainSee the site

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and young people with cystic fibrosis. It tests game-based phone apps against usual breathing techniques for clearing the airways.

Age
8 to 20 years
Sex
All sexes can join.
Disease stage
Cystic fibrosis. Lung function (FVC and FEV1) must not be below 40%.
Earlier treatment
People can join whether or not they take CFTR modulators such as Kaftrio or Kalydeco.
Biomarker or test result
Any specific CF gene mutation is allowed.

Main reasons for not taking part

  • FVC and/or FEV1 below 40%
  • Oxygen therapy or continuous mechanical ventilation
  • Moderate hemoptysis or a pneumothorax in the past 3 months
  • Active, uncontrolled lung infection flare that needed hospital care in the past 30 days
  • Neuromuscular disorders or cognitive difficulties (Mini-Mental State Examination score below 19)

Read by machine on 9 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 8 and 20 years old?

Source: NCT06958094, who can take part

Where in Spain

  • Asociación Andaluza de Fibrosis QuísticaSeville, SpainContact: Prof. Alvaro Alba Rueda, Master. Current PhD studentNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Universidad de Córdoba
Trial code
NCT06958094
Record updated
8 May 2025
Original description
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 fibrosis. Primary outcomes include Forced Vital Capacity (FVC), Forced Expiratory Volume in the first second (FEV₁), adherence to therapy, health-related quality of life (HRQoL), and satisfaction with the intervention. The intervention will consist of 20-minute sessions, performed twice daily over a 24-week period. At least a total of 36 participants aged 8 to 18 years with cystic fibrosis will be randomly assigned to three equally sized groups: the experimental group (gamified mHealth apps: Voice Volume Catcher, Scream Go Hero, and Chicken Scream), the control group (conventional airway clearance techniques: Autogenic Drainage, Active Cycle of Breathing Techniques, and Positive Expiratory Pressure therapy), and the mixed group (10 minutes of gamified mHealth apps combined with 10 minutes of conventional techniques). This study seeks to provide evidence on the feasibility and clinical benefits of integrating gamification into airway clearance therapy to improve respiratory outcomes and patient engagement in pediatric cystic fibrosis care.Read full original descriptionShow less

Effectiveness of Gamified Mobile Health Apps for Airway Clearance Therapy in Children and Adolescents With Cystic Fibrosis: A 24-Week Randomized Controlled Trial.

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 fibrosis. Primary outcomes include Forced Vital Capacity (FVC), Forced Expiratory Volume in the first second (FEV₁), adherence to therapy, health-related quality of life (HRQoL), and satisfaction with the intervention. The intervention will consist of 20-minute sessions, performed twice daily over a 24-week period. At least a total of 36 participants aged 8 to 18 years with cystic fibrosis will be randomly assigned to three equally sized groups: the experimental group (gamified mHealth apps: Voice Volume Catcher, Scream Go Hero, and Chicken Scream), the control group (conventional airway clearance techniques: Autogenic Drainage, Active Cycle of Breathing Techniques, and Positive Expiratory Pressure therapy), and the mixed group (10 minutes of gamified mHealth apps combined with 10 minutes of conventional techniques). This study seeks to provide evidence on the feasibility and clinical benefits of integrating gamification into airway clearance therapy to improve respiratory outcomes and patient engagement in pediatric cystic fibrosis care.

Inclusion Criteria:; 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 Criteria:; 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).

ClinicalTrials.gov NCT06958094