An interventional study of Digital-Gamified Diaphragmatic Training (DGDT) and Standard Mechanical Incentive Spirometer in Pediatric Asthma, Chronic Respiratory Diseases and Obstructive Airway Disease, sponsored by Delta University for Science and Technology. Active, not recruiting at 1 site in Egypt. Open to participants aged 6 Years to 14 Years. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Delta University for Science and Technology · Not applicable, Interventional, and Supportive care
Adherence to traditional pediatric pulmonary rehabilitation exercises is often low due to their repetitive nature, leading to poor respiratory outcomes. Digital-Gamified Diaphragmatic Training (DGDT) integrates real-time biofeedback into smartphone applications to turn breathing exercises into interactive games, encouraging children to practice more consistently. The purpose of this prospective, randomized controlled clinical trial is to evaluate the clinical efficacy of a 12-week home-based DGDT protocol compared to standard mechanical incentive spirometry among pediatric patients aged 6 to 14 years with chronic respiratory conditions. The primary goal is to assess changes in key spirometric parameters-specifically Forced Expiratory Volume in 1 Second (FEV1), Forced Vital Capacity (FVC), and the FEV1/FVC ratio-to determine if gamified digital training offers physiological benefits over standard rehabilitation methods.
Pediatric patients with chronic restrictive or obstructive pulmonary conditions often face challenges maintaining compliance with home rehabilitation regimens. This multi-center, parallel-group randomized clinical trial (1:1 allocation ratio) evaluates whether a low-cost, decentralized digital application can improve objective pulmonary metrics and exercise adherence in pediatric cohorts. Study Procedures:
Eligible participants aged 6-14 years are randomized to either the DGDT Intervention Group or the Standard Control Group. Intervention Group: Participants download an open-access interactive gamified breathing application on their household smartphone. Patients perform guided diaphragmatic breathing for 15 minutes twice daily for 12 weeks. The application provides real-time acoustic/visual feedback to promote controlled inhalation and prolonged exhalation while logging compliance data. Control Group: Participants receive standard three-ball mechanical incentive spirometers and perform an identical schedule (15 minutes, twice daily for 12 weeks) with manual logbook tracking. Outcome Evaluation \& Biosafety:
Spirometric assessments are conducted at baseline, Week 6 (midpoint), and Week 12 (study exit) across outpatient pediatric clinics. To optimize resources and biosafety, baseline and follow-up clinical testing utilize a centralized clinical-grade smart pocket spirometer (MIR Spirobank Smart) with single-use disposable cardboard/plastic mouthpieces and medical-grade sterilization between tests. Statistical Plan:
Changes in FEV1, FVC, and FEV1/FVC ratios from baseline to 6 and 12 weeks will be analyzed using Repeated Measures Analysis of Variance (RM-ANOVA), following an Intent-to-Treat (ITT) approach.
202 studies on the registry are indexed under Lung Diseases, Obstructive; 22 are open to participants now.
This study's enrollment of 170 is above the median of 112 across 123 interventional studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive studies →Delta University for Science and Technology is the lead sponsor of 86 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- Occurrence of an acute pulmonary exacerbation, status asthmaticus, or respiratory tract infection requiring hospitalization within the last 30 days.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants undergo a 12-week home-based protocol using an open-access interactive gamified breathing application on a mobile device for 15 minutes twice daily.
Behavioral: Digital-Gamified Diaphragmatic Training (DGDT)
Participants perform 12 weeks of standard home-based respiratory exercise using a traditional 3-ball mechanical incentive spirometer for 15 minutes twice daily.
Device: Standard Mechanical Incentive Spirometer
Interactive mobile application providing real-time biofeedback and acoustic/visual gamification mechanics to guide slow, deep diaphragmatic breathing and prolonged exhalations.
Standard non-gamified three-ball plastic incentive spirometer utilized for daily respiratory exercise with manual logbook recording.
Change from Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Measured in liters (L) using a clinical-grade smart pocket spirometer to evaluate dynamic lung function and expiratory flow improvement.
Time frame: Baseline, Week 6 (midpoint), and Week 12 (study exit)
Change from Baseline in Forced Vital Capacity (FVC)
Measured in liters (L) via spirometry to evaluate total capacity of air forcefully exhaled following maximum inhalation.
Time frame: Baseline, Week 6 (midpoint), and Week 12 (study exit)
Change from Baseline in FEV1/FVC Ratio
Calculated as the ratio of Forced Expiratory Volume in 1 second to Forced Vital Capacity (expressed as a percentage) to assess airway obstruction severity
Time frame: Baseline, Week 6 (midpoint), and Week 12 (study exit)
Treatment Adherence Rate
Percentage of completed diaphragmatic breathing training sessions logged digitally via the mobile application (intervention group) or manually via logbooks (control group)
Time frame: Continuously over 12 weeks
Plan to share: Yes — De-identified individual participant data (including baseline demographics, spirometric parameters FEV1, FVC, FEV1/FVC, and adherence rates) will be made available upon reasonable request to academic researchers.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will become available beginning 6 months following primary publication and will remain accessible for up to 3 years.
Access criteria: Requests must be directed to the Principal Investigator via email with a formally approved scientific proposal and data transfer agreement. All shared data will remain strictly anonymized in accordance with institutional IRB privacy guidelines.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Delta University for Science and Technology