The Effect of Self-care Emphasizing on Balloon-Blowing Exercise Program on Severity of Sleep Apne… (NCT06780982) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Self-care Emphasizing on Balloon-Blowing Exercise Program on Severity of Sleep Apnea and Respiratory Muscle Strength Among School Age Children With Obstructive Sleep Apnea
Thailand30 participantsStarted 2024-02-12
Plain-language summary
Obstructive sleep apnea (OSA) is a common condition in school-age children, often leading to sleep disturbances and associated health issues. Non-invasive interventions, such as respiratory muscle training, have shown promise in mitigating the severity of OSA. This study explores the effects of a self-care-focused balloon-blowing exercise program on improving respiratory muscle strength and reducing OSA severity in children.
This research aimed to study the effects of a self-care emphasizing on balloon-blowing exercises program on severity of sleep apnea and respiratory muscle strength in school-aged children diagnosed with mild to moderate obstructive sleep apnea (OSA), receiving treatment at the outpatient ENT department at Siriraj Hospital.
Who can participate
Age range
6 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* School-age children aged 6-12 years diagnosed with obstructive sleep apnea (OSA) of mild to moderate severity (AHI 1-9 events/hour).
* Children receiving a consistent medication dosage with no planned adjustments to increase the dosage.
* Fully conscious, with no hearing problems, and able to understand the Thai language.
* Children voluntarily agree to participate in the study, and their parents consent to provide care during the research period.
* Have a smartphone or tablet capable of using the LINE application, with the ability to operate the application under parental supervision.
* Agree to allow the researcher to communicate via LINE and phone calls.
Exclusion Criteria:
* Children with severe comorbidities or chronic illnesses requiring ongoing treatment.
* Children undergoing treatment with continuous positive airway pressure (CPAP) therapy.
* Children who have engaged in exercise sessions lasting more than 20 minutes per session, at least 3 times per week, within the 6 months prior to the start of data collection.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Respiratory Muscle strength
Timeframe: Change from Baseline Respiratory Muscle strength at 5 weeks