The goal of this clinical trial is to learn whether aerobic exercise can improve sleep and nervous system regulation in adults with mild to moderate obstructive sleep apnea (OSA). The study will also examine whether exercise changes blood markers related to inflammation and brain health.
The main questions this study aims to answer are:
1. Does four weeks of aerobic exercise change blood levels of irisin, brain-derived neurotrophic factor (BDNF), and markers related to inflammation? 2. Does aerobic exercise improve sleep apnea, heart rate variability, cognitive function, daytime sleepiness, sleep quality, and daily functioning?
Researchers will compare an aerobic exercise group with a sleep education group to determine whether adding regular aerobic exercise provides additional benefits for people with mild to moderate OSA.
Participants will be randomly assigned to one of two groups.
Participants in the aerobic exercise group will:
1. Receive sleep education. 2. Complete four weeks of supervised treadmill exercise, three to five times per week. Each session will last about 45 to 60 minutes. Exercise intensity will be adjusted to each participant's heart rate and physical condition.
Participants in the comparison group will:
1. Receive sleep education about OSA, common symptoms, treatment options, and healthy sleep habits. 2. Practice the recommended healthy sleep habits at home during the four-week study period.
Participants in both groups will complete assessments before and after the four-week study period. These assessments will include an overnight sleep study, blood tests, heart rate measurements, cognitive tests, and questionnaires about daytime sleepiness, sleep quality, and daily functioning.
Adults aged 20 years or older
Diagnosed with mild to moderate pure obstructive sleep apnea by polysomnography (PSG)
Body mass index (BMI) between 18 and 40 kg/m²
Central or mixed sleep apnea
History of central or peripheral neurological disorders, such as dementia
Musculoskeletal disorders that prevent participation in the prescribed exercise program
Cardiovascular conditions associated with a high risk for exercise
Parallel
Supervised Aerobic Exercise
BehavioralParticipants will receive a 4-week supervised treadmill aerobic exercise program, performed 3-5 times per week for approximately 45-60 minutes per session. Exercise intensity will be individualized based on cardiopulmonary exercise testing (CPET)-derived parameters and progressively adjusted during the intervention. Each session will include warm-up, aerobic exercise, and cool-down periods.
Sleep Hygiene Education
BehavioralParticipants will receive a 20-30-minute sleep education session covering basic information about obstructive sleep apnea, common symptoms, treatment options, and sleep hygiene principles. Participants will be instructed to practice the recommended sleep hygiene strategies at home during the 4-week study period.
Change in Apnea-Hypopnea Index (AHI)
Description: 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)
The oxygen desaturation index (ODI) will be assessed using overnight polysomnography and will be used to evaluate changes in the frequency of nocturnal oxygen desaturation events following the intervention.
Change in Irisin Level
Blood irisin levels will be measured before and after the intervention using an enzyme-linked immunosorbent assay to evaluate exercise-related changes in circulating irisin.
Change in Brain-Derived Neurotrophic Factor (BDNF) Level
Blood BDNF levels will be measured before and after the intervention using an enzyme-linked immunosorbent assay to evaluate changes in BDNF associated with aerobic exercise.
Change in Sleep Efficiency
Sleep efficiency will be assessed using overnight polysomnography and expressed as the percentage of total sleep time relative to time spent in bed. It will be used to evaluate changes in objective sleep quality following the 4-week intervention.
Change in Arousal Index
The arousal index will be assessed using overnight polysomnography and expressed as the number of arousals per hour of sleep. It will be used to evaluate changes in sleep fragmentation following the intervention.
Change in Blood Interleukin-6 (IL-6) Level
Blood interleukin-6 (IL-6) levels will be measured before and after the intervention using an enzyme-linked immunosorbent assay (ELISA). IL-6 will be used as a marker of systemic pro-inflammatory activity to evaluate whether aerobic exercise reduces inflammation in participants with obstructive sleep apnea.
Change in Blood Interleukin-1 Beta (IL-1β) Level
Blood interleukin-1 beta (IL-1β) levels will be measured before and after the intervention using an enzyme-linked immunosorbent assay (ELISA). IL-1β will be used as a marker of systemic pro-inflammatory activity to evaluate changes in inflammatory response following aerobic exercise.
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