Obstructive Sleep ApneaNCT07799753
The Impact of Exercise on Irisin-BDNF Regulation in Obstructive Sleep Apnea
A study testing Supervised Aerobic Exercise and Sleep Hygiene Education in people with Obstructive Sleep Apnea, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 68 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Supervised Aerobic Exercise and Sleep Hygiene Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2026to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
National Cheng Kung University Hospital
Tainan, 704
Ching-Hsia Hung, PhD, +886-6-2353535 ext. 5939, chhung@mail.ncku.edu.tw
About this study
Official title: The Impact of Exercise on Irisin-Brain-Derived Neurotrophic Factor Regulation in Obstructive Sleep Apnea-Related Neuroinflammation: From Animal Model to Clinical Study
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:
Read more
- 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.
Read the 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 based on cardiopulmonary exercise testing (CPET)-derived parameters 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.
Participants assigned to the control group will receive sleep education covering basic information about OSA, common symptoms, related sleep problems, commonly used treatments, and principles of healthy sleep. Participants will be encouraged to practice the recommended sleep hygiene strategies during the four-week study period. A physical therapist will contact participants during the intervention period to follow up on their participation and general condition.
Assessments will be conducted before the intervention and after completion of the four-week intervention. These assessments will include polysomnography, cardiopulmonary exercise testing (CPET), blood sampling, heart rate variability analysis, cognitive testing, and sleep-related questionnaires.
Blood samples will be collected to examine exercise-related changes in irisin and inflammatory and anti-inflammatory biomarkers. The study will also investigate the BDNF-related response to exercise as part of the proposed irisin-BDNF regulatory pathway. Heart rate variability will be assessed to evaluate autonomic nervous system regulation and sympathetic-parasympathetic balance.
Cognitive assessments will evaluate domains including processing speed, attention, working memory, cognitive flexibility, and executive function. Sleep-related questionnaires will be used to assess daytime sleepiness and subjective sleep quality.
Through the integration of physiological biomarkers, sleep measurements, autonomic nervous system assessment, and cognitive outcomes, this study aims to better understand the potential mechanisms through which aerobic exercise may benefit individuals with mild to moderate OSA. The findings may provide evidence for the potential role of exercise as a non-pharmacological adjunctive strategy for improving OSA-related physiological and neurocognitive dysfunction.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Supervised Aerobic Exercise, Sleep Hygiene Education
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Aerobic ExerciseBehavioural
Participants 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 EducationBehavioural
Participants 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.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise Group | Experimental | Participants will receive sleep education plus a 4-week supervised aerobic exercise intervention. Receives: Behavioral: Supervised Aerobic Exercise; Behavioral: Sleep Hygiene Education |
| Sleep Hygiene Education | Active comparator | Participants will receive sleep education only during the 4-week study period. Receives: Behavioral: Sleep Hygiene Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 4
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.
Measured: Baseline and Week 4
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.
Measured: Baseline and Week 4
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.
Measured: Baseline and Week 4
Secondary outcomes (18)
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.
Measured: Baseline and Week 4
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.
Measured: Baseline and Week 4
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.
Measured: Baseline and Week 4
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.
Measured: Baseline and Week 4
Change in Blood Tumor Necrosis Factor-Alpha (TNF-α) Level
Blood tumor necrosis factor-alpha (TNF-α) levels will be measured before and after the intervention using an enzyme-linked immunosorbent assay (ELISA). TNF-α will be used as a marker of systemic pro-inflammatory activity to evaluate the effect of aerobic exercise on inflammation associated with obstructive sleep apnea.
Measured: Baseline and Week 4
Change in Blood Interleukin-10 (IL-10) Level
Blood interleukin-10 (IL-10) levels will be measured before and after the intervention using an enzyme-linked immunosorbent assay (ELISA). IL-10 will be used as a marker of anti-inflammatory activity to evaluate changes in systemic inflammatory regulation following aerobic exercise.
Measured: Baseline and Week 4
Change in Standard Deviation of Normal-to-Normal Intervals (SDNN)
SDNN will be derived from normal-to-normal R-R intervals obtained using a wearable ECG sensor and analyzed using Kubios HRV software. Data will be presented in milliseconds (ms). Higher SDNN values indicate greater overall heart rate variability.
Measured: Baseline and Week 4
Change in Root Mean Square of Successive Differences (RMSSD)
RMSSD will be derived from normal-to-normal R-R intervals obtained using a wearable ECG sensor and analyzed using Kubios HRV software. Data will be presented in milliseconds (ms). Higher RMSSD values generally indicate greater parasympathetic cardiac modulation.
Measured: Baseline and Week 4
Change in Low-Frequency to High-Frequency Power Ratio (LF/HF Ratio)
The LF/HF ratio will be calculated from frequency-domain heart rate variability analysis using Kubios HRV software. It will be used to evaluate changes in autonomic nervous system regulation and sympathetic-parasympathetic balance following the intervention.
Measured: Baseline and Week 4
Change in Digit Symbol Substitution Test (DSST) Performance
The Digit Symbol Substitution Test will be used to assess processing speed, attention efficiency, and related cognitive performance. Participants will match symbols with corresponding numbers within 120 seconds. The raw score will be used for analysis, with higher scores indicating better performance.
Measured: Baseline and Week 4
Change in Digit Span Test Performance
The Digit Span Test will be used to assess attention, short-term memory, and working memory. Forward and backward digit span performance will be evaluated before and after the intervention. Higher scores indicate better cognitive performance.
Measured: Baseline and Week 4
Change in Stroop Color-Word Test Performance
The Stroop Color-Word Test will be used to assess attention, selective attention, inhibitory control, and executive function. Performance will be evaluated using completion time, errors, and interference-related performance as specified in the study protocol. Shorter completion time and fewer errors indicate better cognitive performance. Changes from baseline to Week 4 will be compared between groups.
Measured: Baseline and Week 4
Change in Trail Making Test Performance
Performance will be evaluated using completion time for Parts A and B. Shorter completion time indicates better performance. Changes from baseline to Week 4 will be compared between groups.
Measured: Baseline and Week 4
Change in Epworth Sleepiness Scale (ESS) Score
The Epworth Sleepiness Scale will be used to assess subjective daytime sleepiness. The scale consists of eight situations rated from 0 to 3, resulting in a total score ranging from 0 to 24. Higher scores indicate greater daytime sleepiness.
Measured: Baseline and Week 4
Change in Pittsburgh Sleep Quality Index (PSQI) Score
The Pittsburgh Sleep Quality Index will be used to assess subjective sleep quality over the previous month. The questionnaire evaluates multiple components of sleep quality and produces a total score ranging from 0 to 21. Higher scores indicate poorer sleep quality.
Measured: Baseline and Week 4
Change in Peak Oxygen Uptake (VO₂peak)
For cardiorespiratory fitness, peak oxygen uptake (VO₂peak) will be measured using cardiopulmonary exercise testing (CPET). Data will be presented in mL/kg/min. A higher value indicates better cardiorespiratory fitness and aerobic exercise capacity.
Measured: Baseline and Week 4
Change in Oxygen Uptake at Anaerobic Threshold (VO₂ at AT)
For submaximal aerobic exercise capacity, oxygen uptake at the anaerobic threshold (VO₂ at AT) will be assessed using cardiopulmonary exercise testing (CPET). Data will be presented in mL/kg/min. A higher value indicates greater submaximal aerobic exercise capacity.
Measured: Baseline and Week 4
Change in Work Rate at Anaerobic Threshold
Work rate at the anaerobic threshold will be assessed using cardiopulmonary exercise testing (CPET) performed on a cycle ergometer. Data will be presented in watts. A higher value indicates greater exercise capacity at the anaerobic threshold.
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ching-Hsia Hung, PhD, Principal investigator, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799753
- Sponsor's protocol ID
- B-BR-115-022
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Exercise on Irisin-Brain-Derived Neurotrophic Factor Regulation in Obstructive Sleep Apnea-Related Neuroinflammation: From Animal Model to Clinical Study
- ClinicalTrials.gov ID
- NCT07799753
- Acronym / sponsor ID
- B-BR-115-022
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 based on cardiopulmonary exercise testing (CPET)-derived parameters 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.
Participants assigned to the control group will receive sleep education covering basic information about OSA, common symptoms, related sleep problems, commonly used treatments, and principles of healthy sleep. Participants will be encouraged to practice the recommended sleep hygiene strategies during the four-week study period. A physical therapist will contact participants during the intervention period to follow up on their participation and general condition.
Assessments will be conducted before the intervention and after completion of the four-week intervention. These assessments will include polysomnography, cardiopulmonary exercise testing (CPET), blood sampling, heart rate variability analysis, cognitive testing, and sleep-related questionnaires.
Blood samples will be collected to examine exercise-related changes in irisin and inflammatory and anti-inflammatory biomarkers. The study will also investigate the BDNF-related response to exercise as part of the proposed irisin-BDNF regulatory pathway. Heart rate variability will be assessed to evaluate autonomic nervous system regulation and sympathetic-parasympathetic balance.
Cognitive assessments will evaluate domains including processing speed, attention, working memory, cognitive flexibility, and executive function. Sleep-related questionnaires will be used to assess daytime sleepiness and subjective sleep quality.
Through the integration of physiological biomarkers, sleep measurements, autonomic nervous system assessment, and cognitive outcomes, this study aims to better understand the potential mechanisms through which aerobic exercise may benefit individuals with mild to moderate OSA. The findings may provide evidence for the potential role of exercise as a non-pharmacological adjunctive strategy for improving OSA-related physiological and neurocognitive dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise Group | Experimental | Behavioral: Supervised Aerobic Exercise, Behavioral: Sleep Hygiene EducationParticipants will receive sleep education plus a 4-week supervised aerobic exercise intervention. |
| Sleep Hygiene Education | Active comparator | Behavioral: Sleep Hygiene EducationParticipants will receive sleep education only during the 4-week study period. |
Who may qualify
- Ages
- 20 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised Aerobic ExerciseParticipants 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. | Behavioural | Aerobic Exercise Group |
| Sleep Hygiene EducationParticipants 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. | Behavioural | Aerobic Exercise Group, Sleep Hygiene Education |
Primary outcome
Change in Apnea-Hypopnea Index (AHI)
Time frame: Baseline and Week 4
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)
Time frame: Baseline and Week 4
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
Time frame: Baseline and Week 4
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
Time frame: Baseline and Week 4
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.
18 secondary outcomes
Change in Sleep Efficiency
Time frame: Baseline and Week 4
Change in Arousal Index
Time frame: Baseline and Week 4
Change in Blood Interleukin-6 (IL-6) Level
Time frame: Baseline and Week 4
Change in Blood Interleukin-1 Beta (IL-1β) Level
Time frame: Baseline and Week 4
Change in Blood Tumor Necrosis Factor-Alpha (TNF-α) Level
Time frame: Baseline and Week 4
Change in Blood Interleukin-10 (IL-10) Level
Time frame: Baseline and Week 4
Change in Standard Deviation of Normal-to-Normal Intervals (SDNN)
Time frame: Baseline and Week 4
Change in Root Mean Square of Successive Differences (RMSSD)
Time frame: Baseline and Week 4
Change in Low-Frequency to High-Frequency Power Ratio (LF/HF Ratio)
Time frame: Baseline and Week 4
Change in Digit Symbol Substitution Test (DSST) Performance
Time frame: Baseline and Week 4
Change in Digit Span Test Performance
Time frame: Baseline and Week 4
Change in Stroop Color-Word Test Performance
Time frame: Baseline and Week 4
Change in Trail Making Test Performance
Time frame: Baseline and Week 4
Change in Epworth Sleepiness Scale (ESS) Score
Time frame: Baseline and Week 4
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: Baseline and Week 4
Change in Peak Oxygen Uptake (VO₂peak)
Time frame: Baseline and Week 4
Change in Oxygen Uptake at Anaerobic Threshold (VO₂ at AT)
Time frame: Baseline and Week 4
Change in Work Rate at Anaerobic Threshold
Time frame: Baseline and Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ching-Hsia Hung, PhD principal investigator
National Cheng Kung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Aerobic Exercise and Sleep Hygiene Education in people with Obstructive Sleep Apnea, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi-Ting Wu (+886-973501203, wuyiting1224@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Apnea-Hypopnea Index (AHI) (time frame: Baseline and Week 4). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.