Comprehensive Respiratory Training Exercise Program in Obstructive Sleep Apnea

NCT ID: NCT05739617

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2026-07-16

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 kg.m-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, Müller's 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 ultrasound's findings in the awake stage (normal breathing, functional tasks, and Müller's 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.

Conditions

Obstructive Sleep Apnea of Adult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sleep Hygiene Education

Participants will received once per month of sleep hygiene education for three months.

Group Type: SHAM_COMPARATOR

Sleep hygiene education

Intervention Type: OTHER

Sleep hygiene education

Comprehensive Respiratory Training Exercise Program

Participants will received Comprehensive Respiratory Training Exercise Program twice per weeks for three months.

Group Type: EXPERIMENTAL

Comprehensive Respiratory Training Exercise Program

Intervention Type: OTHER

This comprehensive respiratory training exercise program consists of four main components, including oropharyngeal muscle training, respiratory muscle training, aerobic exercise, and sleep hygiene education.

Interventions

Comprehensive Respiratory Training Exercise Program

This comprehensive respiratory training exercise program consists of four main components, including oropharyngeal muscle training, respiratory muscle training, aerobic exercise, and sleep hygiene education.

Intervention Type: OTHER

Sleep hygiene education

Sleep hygiene education

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Newly diagnosed with OSA (AHI≥ 5 events per hour)
• Age between 20 to 65 years old
• BMI of 18-30 kg.m-2

Exclusion Criteria

• Central or mixed types of sleep apnea
• Neuromuscular disease
• Severe cardiovascular disease
• Active psychiatric disease
• Head or neck disease or cancer
• Structural abnormalities over the upper respiratory airway
• Performed any operation or treatment over the neck before
• Pregnancy

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cheng-Kung University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ching-Hsia Hung, PhD

Role: PRINCIPAL_INVESTIGATOR

National Cheng Kung University

Locations

National Cheng Kung University Hospital

Tainan City, Taiwan, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Jun-Hui Ong, MS

Role: CONTACT

junhui.ong611@gmail.com

+886-9-37839992

Ching-Hsia Hung, PhD

Role: CONTACT

chhung@mail.ncku.edu.tw

+886-6-2353535 ext. 5939

Facility Contacts

Ching-Hsia Hung, PhD

Role: primary

chhung@mail.ncku.edu.tw

06-2353535 ext. 5939

Other Identifiers

A-BR-111-079

Identifier Type: -

Identifier Source: org_study_id