Clinical trial NCT06897761: Development of an Interactive Digital Respiratory Game and Device and Investigation of Its Effectiveness in Children With Bronchiectasis
Official title: Development of an Interactive Digital Respiratory Game and Device and Investigation of Its Effectiveness in Children With Bronchiectasis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bronchiectasis
Keywords: respiratory game, Active Cycle of Breathing Techniques
bronchiectasis
Lead sponsor: Atlas University
Sponsor class: OTHER
First posted: 2025-03-27
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our study aims to develop a personalized interactive digital breathing game and device that can be produced in our country and to provide daily airway cleaning treatment at home via mobile phone or computer without the need for a physiotherapist or healthcare professional with the use of an interactive digital breathing game.

Detailed description: The disruption of airway clearance may lead to obstruction, respiratory infections, gas exchange deterioration, and an increase in mortality and morbidity. Airway clearance is especially crucial in children with bronchiectasis. Postural drainage, manual techniques, positive expiratory pressure, and chest oscillation devices are among airway clearance techniques. The repetitive and frequent use of these techniques strengthens adherence to therapy. With the development of technology and digitalization, Digital Respiratory Games (DRG) offer an alternative solution. DRGs, with their difficulty levels, provide a platform for progression, offering a fun and engaging experience that enhances patient adherence to therapy through storytelling and user interaction. The absence of a locally made DRG in Turkey, despite the chronic respiratory diseases impact, has led to the need for an interactive DRG with personalized features. The developed interactive DRG and device will be Turkey first interactive DRG example, designed to respond to different respiratory maneuvers. The developed DRG and device will detect the lung volume and flow rates and allow for the real-time execution of maneuvers within the Active Cycle of Breathing Techniques (ACBT) in a playful environment. The interactive DRG will enable airway clearance at home and in daily life, without the need for a physiotherapist, in a progressive, fun, and environmentally compatible manner, adjusted to capacity of the user. The interactive DRG and device possess useful model or patentable value and unique features. The aim of the study is to investigate the effectiveness of the locally produced interactive DRG and device in children with bronchiectasis.

The accepted and supported 2022-B-03 call for TUSEB project includes producing personalized interactive digital respiratory games and examining their effects in children with bronchiectasis. A total of 40 children (n=20 in the DRG group and n=20 in the control group) will participate in the study. Participants will perform physical activity exercises specific to their group's treatment protocol, twice a day for 7 days a week, over 8 weeks. Following treatment, their lung function, peripheral respiratory muscles, capacity, treatment adherence, quality of life, and treatment satisfaction will be assessed.

Eligibility criteria: Inclusion Criteria:

* Aged between 7-18 years
* Clinically stable
* No exacerbations or infections
* Possesses a computer, tablet, or mobile phone

Exclusion Criteria:

* Participation in a supervised physiotherapy and rehabilitation program within the last 6 months
* History of lung or liver transplant
* Presence of any cognitive impairment that would hinder the use of the system
* Changes in medical treatment during the study
* Presence of concurrent cardiac, orthopedic, or neurological diseases

Primary outcomes:
measure: 6 Minute Walk Test
timeFrame: baseline and within 1 week after intervention
measure: Evaluation of Expiratory Muscle Strength
timeFrame: baseline and within 1 week after intervention
measure: Evaluation of Inspiratory Muscle Strength
timeFrame: baseline and within 1 week after intervention
Secondary outcomes:
measure: Evaluation of Quality of Life
timeFrame: baseline and within 1 week after intervention
measure: Evaluation of Cough
timeFrame: baseline and within 1 week after intervention
measure: Assessment of Sleep Quality
timeFrame: baseline and within 1 week after intervention
measure: Evaluation of Peripheral Muscle Strength
timeFrame: baseline and within 1 week after intervention
measure: Respiratory Function Test- FEV1 value
timeFrame: baseline and within 1 week after intervention
measure: Respiratory Function Test- FVC value
timeFrame: baseline and within 1 week after intervention
measure: Respiratory Function Test- FEV1/FVC
timeFrame: baseline and within 1 week after intervention
measure: Respiratory Function Test- PEF value
timeFrame: baseline and within 1 week after intervention
Other outcomes:
measure: Evaluation of Participation in the Program
timeFrame: baseline and within 1 week after intervention
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Atlas University
Study officials:
References: