The Impact of Exercise on Irisin-Brain-Derived Neurotrophic Factor Regulation in Obstructive Sleep Apnea-Related Neuroinflammation: From Animal Model to Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Apnea-Hypopnea Index (AHI)
研究概览
简要总结
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:
- Does four weeks of aerobic exercise change blood levels of irisin, brain derived neurotrophic factor (BDNF), and markers related to inflammation?
- 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:
- Receive sleep education.
- 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:
- Receive sleep education about OSA, common symptoms, treatment options, and healthy sleep habits.
- 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.
详细描述
Detailed Description Obstructive sleep apnea (OSA) is a common chronic sleep-related breathing disorder characterized by repeated episodes of upper airway obstruction during sleep. These episodes can result in intermittent hypoxia, sleep fragmentation, oxidative stress, systemic inflammation, and autonomic nervous system imbalance. These physiological changes may also affect neuroplasticity, daytime functioning, and cognitive performance.
Intermittent hypoxia associated with OSA may contribute to increased inflammatory activity and altered regulation of brain-derived neurotrophic factor (BDNF), which plays an important role in neuronal survival and neuroplasticity. Irisin, an exercise-related myokine, has been proposed to have anti-inflammatory and neuroprotective effects and may be involved in the regulation of BDNF. However, the effects of structured aerobic exercise on the relationship among irisin, BDNF, inflammatory responses, autonomic nervous system regulation, sleep, and cognitive function in individuals with OSA remain unclear.
The purpose of this randomized controlled study is to investigate the effects of a four-week aerobic exercise intervention in adults with mild to moderate OSA. The study will examine whether aerobic exercise is associated with changes in circulating irisin, BDNF, inflammatory and anti-inflammatory markers, autonomic nervous system regulation, sleep-related outcomes, and cognitive function.
A total of 50 participants will be randomly assigned to either an aerobic exercise group or a sleep education control group, with 25 participants in each group. Participants in both groups will complete assessments before the intervention and again after four weeks.
Participants assigned to the aerobic exercise group will receive sleep education and participate in a supervised treadmill-based aerobic exercise program for four weeks. Exercise will be performed three to five times per week, with each session lasting approximately 45 to 60 minutes. Each exercise session will include a warm-up period, treadmill aerobic exercise, and a cool-down period. Exercise intensity will be individualized using heart rate reserve and will progressively increase over the four-week intervention period. Exercise sessions will be supervised by a physical therapist, and heart rate, blood pressure, oxygen saturation, and perceived exertion will be monitored to support exercise safety and individualized progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Severe psychiatric disorders
- •Major head and neck diseases or cancer
- •Structural abnormalities of the upper airway
- •Pregnancy
- •Alcohol abuse or circadian rhythm disruption, such as shift work
- •Regular exercise within the 6 months before study enrollment, defined as approximately 150 minutes per week of moderate-intensity exercise or 75 minutes per week of vigorous-intensity exercise
研究组 & 干预措施
Aerobic Exercise Group
Participants will receive sleep education plus a 4-week supervised aerobic exercise intervention.
干预措施: Supervised Aerobic Exercise (Behavioral)
Aerobic Exercise Group
Participants will receive sleep education plus a 4-week supervised aerobic exercise intervention.
干预措施: Sleep Hygiene Education (Behavioral)
Sleep Hygiene Education
Participants will receive sleep education only during the 4-week study period.
干预措施: Sleep Hygiene Education (Behavioral)
结局指标
主要结局
Change in Apnea-Hypopnea Index (AHI)
时间窗: Baseline to 4 week (post-training)
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)
时间窗: Baseline and Week 4 (post-training)
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
时间窗: Baseline to 4 week (post-training)
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
时间窗: Baseline to 4 week (post-training)
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.
次要结局
- Change in Sleep Efficiency(Baseline and Week 4 (post-traininig))
- Change in Arousal Index(Baseline and Week 4 (post-training))
- Change in Blood Interleukin-6 (IL-6) Level(Baseline and Week 4)
- Change in Blood Interleukin-1 Beta (IL-1β) Level(Baseline and Week 4)
- Change in Blood Tumor Necrosis Factor-Alpha (TNF-α) Level(Baseline and Week 4)
- Change in Blood Interleukin-10 (IL-10) Level(Baseline and Week 4)
- Change in Standard Deviation of Normal-to-Normal Intervals (SDNN)(Baseline and Week 4)
- Change in Root Mean Square of Successive Differences (RMSSD)(Baseline and Week 4)
- Change in Low-Frequency to High-Frequency Power Ratio (LF/HF Ratio)(Baseline and Week 4)
- Change in Digit Symbol Substitution Test (DSST) Score(Baseline and Week 4)
- Change in Digit Span Test Score(Baseline and Week 4)
- Change in Stroop Color-Word Test Performance(Baseline and Week 4)
- Change in Trail Making Test Performance(Baseline and Week 4)
- Change in Epworth Sleepiness Scale (ESS) Score(Baseline and Week 4)
- Change in Pittsburgh Sleep Quality Index (PSQI) Score(Baseline and Week 4)