Comprehensive Respiratory Training Exercise Program in Obstructive Sleep Apnea

NCT05739617 | Recruiting

• 1 other identifier: A-BR-111-079
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea of Adult

Outcome Measures

Primary Outcomes (15)

• Change in Apnea-Hypopnea Index (AHI)

  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.

  Baseline to 3 months (post-training)

• Change in Oxygen Desaturation Index (ODI)

  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.

  Baseline to 3 months (post-training)

• Change in Maximum Oxygen Consumption (Vo2max)

  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.

  Baseline to 3 months (post-training)

• Change in Tongue Muscle Thickness

  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.

  Baseline to 3 months (post-training)

• Change in Tongue Muscle Stiffness

  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.

  Baseline to 3 months (post-training)

• Change in Tongue Muscle Strength

  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.

  Baseline to 3 months (post-training)

• Change in Tongue Muscle Endurance

  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.

  Baseline to 3 months (post-training)

• Change in Jaw strength

  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.

  Baseline to 3 months (post-training)

• Change in Pharyngeal Airway Volume

  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.

  Baseline to 3 months (post-training)

• Change in Cross Section Area on the Tip of Epiglottis

  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.

  Baseline to 3 months (post-training)

• Change in Anterior to Posterior Distance on the Tip of the Epiglottis

  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.

  Baseline to 3 months (post-training)

• Change in Lateral Distance on the Tip of Epiglottis

  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.

  Baseline to 3 months (post-training)

• Change in daytime sleepiness

  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.

  Baseline to 3 months (post-training)

• Change in Drug-induced Sleep Endoscopy (DISE)

  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.

  Baseline to 3 months (post-training)

• Change in sleep quality

  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.

  Baseline to 3 months (post-training)

Secondary Outcomes (4)

• Change in Maximal Inspiratory Pressure (PImax)

  Baseline to 3 months (post-training)

• Change in Maximal Expiratory Pressure (PEmax)

  Baseline to 3 months (post-training)

• Change in forced vital capacity (FVC) % predicted

  Baseline to 3 months (post-training)

• Change in Forced Expiratory Volume in one second (FEV1)/ forced vital capacity(FVC) %

  Baseline to 3 months (post-training)

Study Arms (2)

Sleep Hygiene Education

SHAM COMPARATOR

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

Other: Sleep hygiene education

Comprehensive Respiratory Training Exercise Program

EXPERIMENTAL

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

Other: Comprehensive Respiratory Training Exercise Program

Interventions

Comprehensive Respiratory Training Exercise Program 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.

Comprehensive Respiratory Training Exercise Program

Sleep hygiene education OTHER

Sleep hygiene education

Sleep Hygiene Education

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Taiwan, 704, Taiwan

RECRUITING

Study Officials

• Ching-Hsia Hung, PhD

  National Cheng Kung University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun-Hui Ong, MS

CONTACT

+886-9-37839992; junhui.ong611@gmail.com

Ching-Hsia Hung, PhD

CONTACT

+886-6-2353535; chhung@mail.ncku.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 22, 2023
• Study Start: March 1, 2023
• Primary Completion (Estimated): May 20, 2026
• Study Completion (Estimated): July 16, 2026
• Last Updated: June 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)