Clinical trial NCT05739617: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea of Adult
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Apnea-Hypopnea Index (AHI)
timeFrame: Baseline to 3 months (post-training)
measure: Change in Oxygen Desaturation Index (ODI)
timeFrame: Baseline to 3 months (post-training)
measure: Change in Maximum Oxygen Consumption (Vo2max)
timeFrame: Baseline to 3 months (post-training)
measure: Change in Tongue Muscle Thickness
timeFrame: Baseline to 3 months (post-training)
measure: Change in Tongue Muscle Stiffness
timeFrame: Baseline to 3 months (post-training)
measure: Change in Tongue Muscle Strength
timeFrame: Baseline to 3 months (post-training)
measure: Change in Tongue Muscle Endurance
timeFrame: Baseline to 3 months (post-training)
measure: Change in Jaw strength
timeFrame: Baseline to 3 months (post-training)
measure: Change in Pharyngeal Airway Volume
timeFrame: Baseline to 3 months (post-training)
measure: Change in Cross Section Area on the Tip of Epiglottis
timeFrame: Baseline to 3 months (post-training)
measure: Change in Anterior to Posterior Distance on the Tip of the Epiglottis
timeFrame: Baseline to 3 months (post-training)
measure: Change in Lateral Distance on the Tip of Epiglottis
timeFrame: Baseline to 3 months (post-training)
measure: Change in daytime sleepiness
timeFrame: Baseline to 3 months (post-training)
measure: Change in Drug-induced Sleep Endoscopy (DISE)
timeFrame: Baseline to 3 months (post-training)
measure: Change in sleep quality
timeFrame: Baseline to 3 months (post-training)
Secondary outcomes:
measure: Change in Maximal Inspiratory Pressure (PImax)
timeFrame: Baseline to 3 months (post-training)
measure: Change in Maximal Expiratory Pressure (PEmax)
timeFrame: Baseline to 3 months (post-training)
measure: Change in forced vital capacity (FVC) % predicted
timeFrame: Baseline to 3 months (post-training)
measure: Change in Forced Expiratory Volume in one second (FEV1)/ forced vital capacity(FVC) %
timeFrame: Baseline to 3 months (post-training)
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: National Cheng Kung University
name: Ching-Hsia Hung, PhD
role: PRINCIPAL_INVESTIGATOR
References: