Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05739617
Status:
RECRUITING
Last Update Posted:
2024-03-21
First Post:
2023-02-08
Brief Title:
Comprehensive Respiratory Training Exercise Program in Obstructive Sleep Apnea
Sponsor:
National Cheng-Kung University Hospital
Organization:
National Cheng-Kung University Hospital
Study Overview
Official Title:
Combining Sonography to Explore the Therapeutic Effect and Mechanism of a Comprehensive Respiratory Training Exercise Program on Cardiorespiratory Endurance and Airway Muscle Function in Obstructive Sleep Apnea
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Obstructive sleep apnea OSA is a multi-factorial sleep disorder Complete collapse or partial collapse in the airway increases the risk of developing cardiovascular and kidney-related disease in OSA patients Resulting in an increase in medical expenses and workload for the healthcare worker Multilevel of upper airway muscles especially the genioglossus muscle showed to contribute to airway obstruction as it fatigues easily The endurance level of OSA patients was shown to be significantly lower Therefore the goal of this experimental study is to assess the feasibility and effectiveness of a comprehensive respiratory training exercise program on cardiorespiratory endurance airway muscle function and sleep parameters in patients with obstructive sleep apnea OSA Aside from exploring the therapeutic effect the results of the study will be used to explore the mechanism of the treatment in relation to the changes in the OSA severity
Detailed Description:
Newly diagnosed OSA subjects aged 20-65 years old and with body mass index between 18-30 kgm-2 will be recruited The participants will be randomly divided into the control group sleep hygiene education and the intervention group comprehensive respiratory training exercise program Participants from the intervention group will undergo 3 months of a comprehensive respiratory training exercise program while the control group will be provided sleep hygiene education Polysomnography PSG cardiopulmonary exercise testing sonography during the awake stage functional tasks Müllers maneuver and natural sleep tongue strength and tongue endurance assessment jaw strength measurement Computed Tomography CT Drug-Induced Sleep Endoscopy DISE respiratory muscle strength pulmonary function test and sleep quality questionnaires will be collected before and after 3 months of intervention
Expected contribution to clinical medicine
The feasibility of this comprehensive respiratory training exercise program in improving cardiorespiratory endurance leading to an increase in the survival rate and reduced risk of cardiovascular disease of OSA patients
Based on the ultrasounds findings in the awake stage normal breathing functional tasks and Müllers maneuver and overnight sleep allow a better understanding of the effects of these exercises on the changes of tongue and oropharyngeal structures during the static and dynamic stages
The practicability of the ultrasound assessment in the clinical setting on OSA patients is to identify the changes in the tongue and oropharyngeal structures Based on ultrasound image capture it provides individualized and precise training by modifying the training and providing feedback to OSA patients during their exercise training
Expected contribution to clinical medicine
The feasibility of this comprehensive respiratory training exercise program in improving cardiorespiratory endurance leading to an increase in the survival rate and reduced risk of cardiovascular disease of OSA patients
Based on the ultrasounds findings in the awake stage normal breathing functional tasks and Müllers maneuver and overnight sleep allow a better understanding of the effects of these exercises on the changes of tongue and oropharyngeal structures during the static and dynamic stages
The practicability of the ultrasound assessment in the clinical setting on OSA patients is to identify the changes in the tongue and oropharyngeal structures Based on ultrasound image capture it provides individualized and precise training by modifying the training and providing feedback to OSA patients during their exercise training
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None