Pediatric AsthmaNCT07765264
Clinical and Autonomic Efficacy of Digital-Gamified Diaphragmatic Training in Pediatric Pulmonary Rehabilitation
A study testing Digital-Gamified Diaphragmatic Training (DGDT) and Standard Mechanical Incentive Spirometer in people with Pediatric Asthma and Chronic Respiratory Diseases, run by Delta University for Science and Technology at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Pediatric Asthma, Chronic Respiratory Diseases, Obstructive Airway Disease
- What is being tested?
- Digital-Gamified Diaphragmatic Training (DGDT) and Standard Mechanical Incentive Spirometer
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients aged 6 to 14 years at the time of screening.
- Documented clinical diagnosis of a chronic respiratory condition (e.g., bronchial asthma, post-inflammatory pulmonary conditions), stable under standard pharmacological management for at least 4 consecutive weeks.
- Household access to a functional smartphone (Android or iOS) capable of running mobile applications.
- Written informed consent provided by a parent or legal guardian, and child's verbal or written assent.
Who cannot join
- Occurrence of an acute pulmonary exacerbation, status asthmaticus, or respiratory tract infection requiring hospitalization within the last 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Being tested
- Digital-Gamified Diaphragmatic Training (DGDT), Standard Mechanical Incentive Spirometer
- Keywords
- Gamification, Pediatrics, Spirometry, Telehealth, Pulmonary Rehabilitation
- Medical subject headings
- Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital-Gamified Diaphragmatic Training (DGDT)Behavioural
Interactive mobile application providing real-time biofeedback and acoustic/visual gamification mechanics to guide slow, deep diaphragmatic breathing and prolonged exhalations.
Standard Mechanical Incentive SpirometerDevice
Standard non-gamified three-ball plastic incentive spirometer utilized for daily respiratory exercise with manual logbook recording.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (DGDT) | Experimental | 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. Receives: Behavioral: Digital-Gamified Diaphragmatic Training (DGDT) |
| Control Group (Standard Care) | Active comparator | Participants perform 12 weeks of standard home-based respiratory exercise using a traditional 3-ball mechanical incentive spirometer for 15 minutes twice daily. Receives: Device: Standard Mechanical Incentive Spirometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: Baseline, Week 6 (midpoint), and Week 12 (study exit)
Secondary outcomes (1)
Treatment Adherence Rate
Percentage of completed diaphragmatic breathing training sessions logged digitally via the mobile application (intervention group) or manually via logbooks (control group)
Measured: Continuously over 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start1 Apr 2026
- Primary completion1 Jul 2026
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 allocation parallel-group trial comparing a 12-week Digital-Gamified Diaphragmatic Training (DGDT) home protocol against standard mechanical incentive spirometry.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07765264
- Sponsor's protocol ID
- R-26-08-0015
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Autonomic Efficacy of Digital-Gamified Diaphragmatic Training in Pediatric Pulmonary Rehabilitation
- ClinicalTrials.gov ID
- NCT07765264
- Acronym / sponsor ID
- R-26-08-0015
- Keywords
- Gamification, Pediatrics, Spirometry, Telehealth, Pulmonary Rehabilitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 allocation parallel-group trial comparing a 12-week Digital-Gamified Diaphragmatic Training (DGDT) home protocol against standard mechanical incentive spirometry.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (DGDT) | Experimental | Behavioral: Digital-Gamified Diaphragmatic Training (DGDT)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. |
| Control Group (Standard Care) | Active comparator | Device: Standard Mechanical Incentive SpirometerParticipants perform 12 weeks of standard home-based respiratory exercise using a traditional 3-ball mechanical incentive spirometer for 15 minutes twice daily. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Pediatric patients aged 6 to 14 years at the time of screening.
- Documented clinical diagnosis of a chronic respiratory condition (e.g., bronchial asthma, post-inflammatory pulmonary conditions), stable under standard pharmacological management for at least 4 consecutive weeks.
- Household access to a functional smartphone (Android or iOS) capable of running mobile applications.
- Written informed consent provided by a parent or legal guardian, and child's verbal or written assent.
Key exclusion criteria (1 listed)
- Occurrence of an acute pulmonary exacerbation, status asthmaticus, or respiratory tract infection requiring hospitalization within the last 30 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital-Gamified Diaphragmatic Training (DGDT)Interactive mobile application providing real-time biofeedback and acoustic/visual gamification mechanics to guide slow, deep diaphragmatic breathing and prolonged exhalations. | Behavioural | Intervention Group (DGDT) |
| Standard Mechanical Incentive SpirometerStandard non-gamified three-ball plastic incentive spirometer utilized for daily respiratory exercise with manual logbook recording. | Device | Control Group (Standard Care) |
Primary outcome
Change from Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline, Week 6 (midpoint), and Week 12 (study exit)
Measured in liters (L) using a clinical-grade smart pocket spirometer to evaluate dynamic lung function and expiratory flow improvement.
Change from Baseline in Forced Vital Capacity (FVC)
Time frame: Baseline, Week 6 (midpoint), and Week 12 (study exit)
Measured in liters (L) via spirometry to evaluate total capacity of air forcefully exhaled following maximum inhalation.
Change from Baseline in FEV1/FVC Ratio
Time frame: Baseline, Week 6 (midpoint), and Week 12 (study exit)
Calculated as the ratio of Forced Expiratory Volume in 1 second to Forced Vital Capacity (expressed as a percentage) to assess airway obstruction severity
1 secondary outcome
Treatment Adherence Rate
Time frame: Continuously over 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital-Gamified Diaphragmatic Training (DGDT) and Standard Mechanical Incentive Spirometer in people with Pediatric Asthma and Chronic Respiratory Diseases, run by Delta University for Science and Technology at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Forced Expiratory Volume in 1 Second (FEV1) (time frame: Baseline, Week 6 (midpoint), and Week 12 (study exit)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.