Obstructive Sleep Apnea of Child"SEES"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
A study testing Balloon-Blowing exercise program and Standard nursing care in people with Obstructive Sleep Apnea of Child, run by Chulalongkorn University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Obstructive Sleep Apnea of Child
- What is being tested?
- Balloon-Blowing exercise program and Standard nursing care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- 12 Feb 2024to 8 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea of Child
- Being tested
- Balloon-Blowing exercise program, Standard nursing care
- Keywords
- Obstructive Sleep Apnea, Self-Efficacy, Balloon-Blowing, Muscle strength
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon-Blowing exercise programBehavioural
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 careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Balloon-blowing exercises | Experimental | The 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:
1. Decision-Making in Self-Care: Discussions to build rapport with the child, assess self-care deficits, and evaluate the child's current self-care behaviors based on their perceptions and experiences.
2. Setting Goals and Planning Self-Care: Explanation self-care behaviors to the child and their parents and collaborate to create a care plan.
3. Self-Care Implementation: The child and parents download educational materials via the LINE application and 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.
4. Maintaining Self-Care Behaviors: Encouragements for performing all five behaviors by having the child review materials via the LINE application once a week. Receives: Behavioral: Balloon-Blowing exercise program |
| Standard nursing care | Experimental | The control group received standard nursing care, which 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. Receives: Behavioral: Standard nursing care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Muscle strength
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
Measured: Change from Baseline Respiratory Muscle strength at 5 weeks
Secondary outcomes (1)
Severity of sleep apnea
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.
Measured: Change from Baseline severity of sleep apnea at 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start12 Feb 2024
- Primary completion16 Mar 2024
- Study completion8 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea of ChildStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suwimon Rojnawee, PhD, RN, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780982
- Sponsor's protocol ID
- 829/66
- Acronym
- "SEES"
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2025
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25348130Koka 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.
PubMed 33915707Schivinski 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.
PubMed 32159645Zecha-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.
PubMed 15081184Misra 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.
PubMed 37440814Marcus 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.
PubMed 8795838Potsic WP. Sleep apnea in children. Otolaryngol Clin North Am. 1989 Jun;22(3):537-44.
PubMed 2657582Ishman 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.
PubMed 38458954Redline 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.
PubMed 38051326Erturk 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.
PubMed 32800391
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06780982
- Acronym / sponsor ID
- "SEES" / 829/66
- Conditions
- Obstructive Sleep Apnea of Child
- Keywords
- Obstructive Sleep Apnea, Self-Efficacy, Balloon-Blowing, Muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 16 Mar 2024 (actual)
- Study completion
- 8 May 2024 (actual)
- First posted
- 17 Jan 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Balloon-blowing exercises | Experimental | Behavioral: Balloon-Blowing exercise programThe 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: 1. Decision-Making in Self-Care: Discussions to build rapport with the child, assess self-care deficits, and evaluate the child's current self-care behaviors based on their perceptions and experiences. 2. Setting Goals and Planning Self-Care: Explanation self-care behaviors to the child and their parents and collaborate to create a care plan. 3. Self-Care Implementation: The child and parents download educational materials via the LINE application and 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. 4. Maintaining Self-Care Behaviors: Encouragements for performing all five behaviors by having the child review materials via the LINE application once a week. |
| Standard nursing care | Experimental | Behavioral: Standard nursing careThe control group received standard nursing care, which 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Balloon-Blowing exercise programhe 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: 1. Decision-Making in Self-Care 2. Setting Goals and Planning Self-Care 3. 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. 4. Maintaining Self-Care Behaviors | Behavioural | Experimental: Balloon-blowing exercises |
| Standard nursing careThe 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. | Behavioural | Standard nursing care |
Primary outcome
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
1 secondary outcome
Severity of sleep apnea
Time frame: Change from Baseline severity of sleep apnea at 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Results publication: PubMed 25348130Camacho 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.
- Results publication: PubMed 33915707Koka 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.
- Results publication: PubMed 32159645Schivinski 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.
- Results publication: PubMed 15081184Zecha-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.
- Results publication: PubMed 37440814Misra 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.
- Results publication: PubMed 8795838Marcus 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.
- Results publication: PubMed 2657582Potsic WP. Sleep apnea in children. Otolaryngol Clin North Am. 1989 Jun;22(3):537-44.
- Results publication: PubMed 38458954Ishman 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.
- Results publication: PubMed 38051326Redline 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.
- Results publication: PubMed 32800391Erturk 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.
- Individual participant dataSharing planned: No
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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 Balloon-Blowing exercise program and Standard nursing care in people with Obstructive Sleep Apnea of Child, run by Chulalongkorn University at 1 site in Thailand.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 17 Jan 2025. 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Respiratory Muscle strength (time frame: Change from Baseline Respiratory Muscle strength at 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06780982, which also lists 10 linked publications.
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 17 Jan 2025.