Clinical trial NCT06780982: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea of Child
Keywords: Obstructive Sleep Apnea
Self-Efficacy
Balloon-Blowing
Muscle strength
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The experimental group received the self-care emphasizing on balloon-blowing exercises program for five weeks based on Orem's self-care theory (2001), while the control group received regular nursing care.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Thirty children participated, divided into two groups: 15 children received the self-care emphasizing on balloon-blowing exercises program for five weeks based on Orem's self-care theory (2001), and 15 children received regular nursing care. The research instruments included a severity assessment scale for apnea and a self-care behavior assessment scale for children with OSA. Both instruments had content validity indexes of 0.95 and 0.80, and their reliability, Cronbach's alpha, were 0.83 and 0.76, respectively. Respiratory muscle strength was measured using a Respiratory Pressure Meter. Data were analyzed using statistical t-tests.

Eligibility criteria: 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.

Primary outcomes:
measure: Respiratory Muscle strength
timeFrame: Change from Baseline Respiratory Muscle strength at 5 weeks
Secondary outcomes:
measure: Severity of sleep apnea
timeFrame: Change from Baseline severity of sleep apnea at 5 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Nursing, Chulalongkorn University
Study officials:
References:
citation: Camacho M, Certal V, Abdullatif J, Zaghi S, Ruoff CM, Capasso R, Kushida CA. Myofunctional Therapy to Treat Obstructive Sleep Apnea: A Systematic Review and Meta-analysis. Sleep. 2015 May 1;38(5):669-75. doi: 10.5665/sleep.4652.
citation: Koka V, De Vito A, Roisman G, Petitjean M, Filograna Pignatelli GR, Padovani D, Randerath W. Orofacial Myofunctional Therapy in Obstructive Sleep Apnea Syndrome: A Pathophysiological Perspective. Medicina (Kaunas). 2021 Apr 1;57(4):323. doi: 10.3390/medicina57040323.
citation: Schivinski CIS, Manna BC, Belem FJDM, Castilho T. THERAPEUTIC BLOWING TOYS: DOES THE OVERLAP OF VENTILATORY STIMULI ALTER THE RESPIRATORY MECHANICS OF HEALTHY SCHOOLCHILDREN? Rev Paul Pediatr. 2020 Mar 9;38:e2018259. doi: 10.1590/1984-0462/2020/38/2018259. eCollection 2020.
citation: Zecha-Stallinger A, Wenzel V, Wagner-Berger HG, von Goedecke A, Lindner KH, Hormann C. A strategy to optimise the performance of the mouth-to-bag resuscitator using small tidal volumes: effects on lung and gastric ventilation in a bench model of an unprotected airway. Resuscitation. 2004 Apr;61(1):69-74. doi: 10.1016/j.resuscitation.2003.12.012.
citation: Misra A, Pawar R, Pal A. Effect of Balloon-Blowing Exercise on Oxygen Saturation in COVID-19 Patients. Cureus. 2023 Jun 11;15(6):e40250. doi: 10.7759/cureus.40250. eCollection 2023 Jun.
citation: Marcus CL, Loughlin GM. Obstructive sleep apnea in children. Semin Pediatr Neurol. 1996 Mar;3(1):23-8. doi: 10.1016/s1071-9091(96)80025-8.
citation: Potsic WP. Sleep apnea in children. Otolaryngol Clin North Am. 1989 Jun;22(3):537-44.
citation: Ishman SL, Li C, Dhanda Patil R. Sleep Renewed: Innovations in Sleep Apnea Care for Adults and Children. Otolaryngol Clin North Am. 2024 Jun;57(3):xv-xvi. doi: 10.1016/j.otc.2024.02.018. Epub 2024 Mar 8. No abstract available.
citation: Redline S, Cook K, Chervin RD, Ishman S, Baldassari CM, Mitchell RB, Tapia IE, Amin R, Hassan F, Ibrahim S, Ross K, Elden LM, Kirkham EM, Zopf D, Shah J, Otteson T, Naqvi K, Owens J, Young L, Furth S, Connolly H, Clark CAC, Bakker JP, Garetz S, Radcliffe J, Taylor HG, Rosen CL, Wang R; Pediatric Adenotonsillectomy Trial for Snoring (PATS) Study Team. Adenotonsillectomy for Snoring and Mild Sleep Apnea in Children: A Randomized Clinical Trial. JAMA. 2023 Dec 5;330(21):2084-2095. doi: 10.1001/jama.2023.22114.
citation: Erturk N, Calik-Kutukcu E, Arikan H, Savci S, Inal-Ince D, Caliskan H, Saglam M, Vardar-Yagli N, Firat H, Celik A, Yuce-Ege M, Ardic S. The effectiveness of oropharyngeal exercises compared to inspiratory muscle training in obstructive sleep apnea: A randomized controlled trial. Heart Lung. 2020 Nov-Dec;49(6):940-948. doi: 10.1016/j.hrtlng.2020.07.014. Epub 2020 Aug 13.