Comprehensive Respiratory Training Exercise Program in Obstructive Sleep Apnea

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

Overview

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.

Interventions

• Other 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.
• Other Sleep hygiene education
  Sleep hygiene education

Primary outcome measures

• Change in Apnea-Hypopnea Index (AHI) [Time frame: Baseline to 3 months (post-training)]
• Change in Oxygen Desaturation Index (ODI) [Time frame: Baseline to 3 months (post-training)]
• Change in Maximum Oxygen Consumption (Vo2max) [Time frame: Baseline to 3 months (post-training)]
• Change in Tongue Muscle Thickness [Time frame: Baseline to 3 months (post-training)]
• Change in Tongue Muscle Stiffness [Time frame: Baseline to 3 months (post-training)]
• Change in Tongue Muscle Strength [Time frame: Baseline to 3 months (post-training)]
• Change in Tongue Muscle Endurance [Time frame: Baseline to 3 months (post-training)]
• Change in Jaw strength [Time frame: Baseline to 3 months (post-training)]
• Change in Pharyngeal Airway Volume [Time frame: Baseline to 3 months (post-training)]
• Change in Cross Section Area on the Tip of Epiglottis [Time frame: Baseline to 3 months (post-training)]

Secondary outcome measures (4)

• Change in Maximal Inspiratory Pressure (PImax) [Time frame: Baseline to 3 months (post-training)]
• Change in Maximal Expiratory Pressure (PEmax) [Time frame: Baseline to 3 months (post-training)]
• Change in forced vital capacity (FVC) % predicted [Time frame: Baseline to 3 months (post-training)]
• Change in Forced Expiratory Volume in one second (FEV1)/ forced vital capacity(FVC) % [Time frame: Baseline to 3 months (post-training)]

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: Diagnosed with any of the following diseases below:

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Taiwan · 1 center

• National Cheng Kung University Hospital — Tainan

Identifiers

NCT: NCT05739617 · A-BR-111-079

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗