Comprehensive Respiratory Training Exercise Program in Obstructive Sleep Apnea

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Sleep hygiene education: Sleep hygiene education

Study 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.

Eligibility

Primary outcome measure(s)

• Change in Apnea-Hypopnea Index (AHI) — Baseline to 3 months (post-training)
  The apnea-hypopnea index will be obtained from the overnight Polysomnography (PSG) study. PSG will be performed in the sleep center of National Cheng Kung University Hospital. Less than 5 events/hour indicates normal; AHI between 5-14 events/hour indicates mild Obstructive Sleep Apnea(OSA); AHI between 15-30 events/hour indicates moderate OSA; and AHI more than 30 events/hour indicates severe OSA.
• Change in Oxygen Desaturation Index (ODI) — Baseline to 3 months (post-training)
  The average number of desaturation episodes per hour (oxygen desaturation index) will be obtained from the overnight Polysomnography (PSG) study. A decrease in the mean oxygen saturation of ≥4% that lasts for at least 10 seconds indicates an episode of desaturation.
• Change in Maximum Oxygen Consumption (Vo2max) — Baseline to 3 months (post-training)
  Maximum oxygen consumption (Vo2max) will be measured using Cardiopulmonary Exercise Testing (CPET) which will be performed on a static bicycle. The average value of Vo2max in adults is approximately 27-48 mL/kg/min. A greater Vo2max value indicates a better physical fitness level.
• Change in Tongue Muscle Thickness — Baseline to 3 months (post-training)
  Sonography will be performed over the participant's neck region to assess the changes in tongue muscle thickness during normal breathing, Müller's maneuver, functional tasks, and natural sleep. The data on tongue thickness will be presented in millimeters. A greater value indicates a thicker in tongue.
• Change in Tongue Muscle Stiffness — Baseline to 3 months (post-training)
  Ultrasound shear-wave elastography will be performed to assess the changes in tongue-based stiffness. The data will be presented in kPa, with a greater value indicating an increase in tongue stiffness. The minimum value is 0 kPa and the maximum value is 220 kPa.
• Change in Tongue Muscle Strength — Baseline to 3 months (post-training)
  The tongue muscle strength will be measured using an Iowa Oral Performance Instrument (IOPI) device, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA). The minimum score is 0 and a higher score indicates stronger in tongue muscle strength.
• Change in Tongue Muscle Endurance — Baseline to 3 months (post-training)
  The tongue muscle endurance will be measured using an Iowa Oral Performance Instrument (IOPI) device, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA). The data will be presented in seconds. The longer the duration of holding (more than 10 seconds), the greater in the tongue muscle endurance.
• Change in Jaw strength — Baseline to 3 months (post-training)
  Jaw strength will be measured using a 'handheld' dynamometer (MicroFET○R2, Hoggan Scientific, USA). The data will be presented in kilogram-weight. The minimum score is 0 and a higher score indicates stronger in jaw strength.
• Change in Pharyngeal Airway Volume — Baseline to 3 months (post-training)
  Computer Tomography (CT) will be performed. The pharyngeal airway volume will be calculated from the hard palate to the epiglottis and the data will be presented in cm3. The minimum score is 0 and a higher score indicates greater in pharyngeal airway volume.
• Change in Cross Section Area on the Tip of Epiglottis — Baseline to 3 months (post-training)
  Computer Tomography (CT) will be performed. Cross section area on the tip of the epiglottis was measured and the data will be presented in cm2. The minimum score is 0 and a higher score indicates greater in the cross-sectional area of the region.
• Change in Anterior to Posterior Distance on the Tip of the Epiglottis — Baseline to 3 months (post-training)
  The distance between the anterior and posterior pharyngeal wall on the tip of the epiglottis will be measured and presented in cm. The minimal value will be 0 and the greater value indicates a greater distance between the anterior to posterior in this area.
• Change in Lateral Distance on the Tip of Epiglottis — Baseline to 3 months (post-training)
  The distance between the lateral distance on the tip of the epiglottis will be measured and presented in cm. The minimal value will be 0 and the greater value indicates a greater distance between the lateral wall.
• Change in daytime sleepiness — Baseline to 3 months (post-training)
  Epworth Sleepiness Score(ESS) will be used to measure the daytime sleepiness of OSA patients. The total score of ESS range from 0-24. A score greater than 10 indicates greater daytime sleepiness.
• Change in Drug-induced Sleep Endoscopy (DISE) — Baseline to 3 months (post-training)
  The level of obstruction, the degree of obstruction, and the configuration of the obstructive will be identified through the drug-induced sleep endoscopy. The degree of obstruction ranged from 0 to 2. 0: no obstruction; 1: partial obstruction; 2: complete obstruction.
• Change in sleep quality — Baseline to 3 months (post-training)
  Sleep quality will be measured using Pittsburgh Sleep Quality Index (PSQI).The total score ranges from 0 to 21 with a higher total score equal to or more than 5 indicating worse sleep quality.

Trial sites (1)

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