Comprehensive Respiratory Training Exercise Program in Obstructive Sleep Apnea

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-65
SponsorNational Cheng-Kung University Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Newly diagnosed with OSA (AHI≥ 5 events per hour)

Age between 20 to 65 years old

BMI of 18-30 kg.m-2

Disqualifiers

Central or mixed types of sleep apnea

Neuromuscular disease

Severe cardiovascular disease

Active psychiatric disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Comprehensive Respiratory Training Exercise Program

    Other intervention

    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

    Other intervention

    Sleep hygiene education

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Sleep Hygiene EducationSham comparator 1 intervention
Group B: Comprehensive Respiratory Training Exercise ProgramExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline to 3 months (post-training)
2

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.

Time frame
Baseline to 3 months (post-training)
3

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.

Time frame
Baseline to 3 months (post-training)
4

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.

Time frame
Baseline to 3 months (post-training)

Secondary outcomes

1

Change in Maximal Inspiratory Pressure (PImax)

For respiratory muscle strength, maximal inspiratory pressure (PImax) will be measured using Respiratory Pressure Meter. Data will be presented in cmH2O. The minimal score will be 0, and a higher value indicates stronger in the inspiratory muscle.

Time frame
Baseline to 3 months (post-training)
2

Change in Maximal Expiratory Pressure (PEmax)

For respiratory muscle strength, maximal expiratory pressure (PEmax) will be measured using Respiratory Pressure Meter. Data will be presented in cmH2O. The minimal score will be 0, and a higher value indicates stronger in the expiratory muscle.

Time frame
Baseline to 3 months (post-training)
3

Change in forced vital capacity (FVC) % predicted

The respiratory muscle function on the forced vital capacity (FVC) % predicted will be collected using spirometry. The normal value is between 80% to 120%; mild abnormality: is 70-79%; moderate abnormality: is 60-69%; severe abnormality: is less than 60%.

Time frame
Baseline to 3 months (post-training)
4

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

The respiratory muscle function on the Forced Expiratory Volume in one second (FEV1)/ forced vital capacity(FVC) will be collected using spirometry. The normal value for the FEV1/FVC % is equal to or greater than 70%; mild abnormality: 60-69%; moderate abnormality: 50-59%; severe abnormality: less than 50%.

Time frame
Baseline to 3 months (post-training)

Other outcomes

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