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NCT Number: 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

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.

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Key information

Conditions

Obstructive Sleep Apnea of Child Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Nursing, Chulalongkorn University

Bangkok, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Balloon-Blowing exercise program

Behavioral

he program begins with a one-on-one session on the first day of the research project and continues with home-based care through the LINE application on a smartphone for 5 weeks. The program consists of four steps:

  • Decision-Making in Self-Care
  • Setting Goals and Planning Self-Care
  • Self-Care Implementation: practicing the balloon-blowing exercise daily for 3 sets of 3 balloons per set (a total of 9 balloons/day), with a 1-minute rest between sets, over a period of 5 weeks.
  • Maintaining Self-Care Behaviors

Standard nursing care

Behavioral

The actions of nurses towards school-age children with obstructive sleep apnea at the hospital involve screening patient records and distributing educational materials in the form of brochures to individual pediatric patients and their parents. The knowledge provided in the brochures includes instructions on how to administer inhaled medication, avoiding allergens, performing facial and neck muscle exercises, and attending follow-up appointments as scheduled.

Primary outcomes

  1. Respiratory Muscle strength

    Time frame: Change from Baseline Respiratory Muscle strength at 5 weeks

    espiratory muscle strength is assessed using a Respiratory Pressure Meter (MicroRPM®) by Micromedical, a brand from the United Kingdom. This device evaluates respiratory muscle strength by measuring the maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP), with results recorded in cmH₂O.

    The maximal inspiratory pressure represents the strength of the inspiratory muscles, while the maximal expiratory pressure reflects the strength of the expiratory muscles. Measurements are obtained by having the participant exert maximal and rapid respiratory effort through the Respiratory Pressure Meter, sustaining the pressure for 2 seconds. Each measurement is repeated three times, and the average of the three readings is recorded in cmH₂O.

    Higher scores indicate greater respiratory muscle strength, while lower scores signify reduced strength. The recorded data is documented in the Maximal Inspiratory and Expiratory Pressure Recording Form (Appendix D). All assessments are con

Secondary outcomes

  1. Severity of sleep apnea

    Time frame: Change from Baseline severity of sleep apnea at 5 weeks

    The severity of sleep apnea is assessed using the Sleep-Related Breathing Disorder Pediatric Sleep Questionnaire (SRBD-PSQ), which evaluates the severity of obstructive sleep apnea (OSA). The questionnaire consists of 22 items addressing the frequency of snoring, loud snoring, observed apneas, difficulty breathing during sleep, daytime sleepiness, hyperactivity or inattention, and symptoms of obstructive sleep apnea. Responses are scored as follows: "Yes" = 1 point, "No" = 0 points, and "Don't know" is considered missing.

    The total score is calculated by summing the scores of all answered items and dividing by the number of items answered (excluding items marked as missing). The score ranges from 0 to 1, with higher scores indicating greater severity of OSA and lower scores indicating less severity.

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Acronym: "SEES"

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 17, 2025
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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