The Impact of Exercise on Irisin-BDNF Regulation in Obstructive Sleep Apnea

NCT07799753 | Not Yet Recruiting

• 1 other identifier: B-BR-115-022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. The main questions this study aims to answer are:

1. 1.Does four weeks of aerobic exercise change blood levels of irisin, brain-derived neurotrophic factor (BDNF), and markers related to inflammation?
2. 2.Does aerobic exercise improve sleep apnea, heart rate variability, cognitive function, daytime sleepiness, sleep quality, and daily functioning?
3. 3.Receive sleep education.
4. 4.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.
5. 5.Receive sleep education about OSA, common symptoms, treatment options, and healthy sleep habits.
6. 6.Practice the recommended healthy sleep habits at home during the four-week study period.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline and Week 4

Secondary Outcomes (18)

• Change in Sleep Efficiency

  Baseline and Week 4

• Change in Arousal Index

  Baseline and Week 4

• 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

Study Arms (2)

Aerobic Exercise Group

EXPERIMENTAL

Participants will receive sleep education plus a 4-week supervised aerobic exercise intervention.

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.

Behavioral: Sleep Hygiene Education

Interventions

Supervised Aerobic Exercise BEHAVIORAL

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.

Aerobic Exercise Group

Sleep Hygiene Education BEHAVIORAL

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.

Aerobic Exercise Group; Sleep Hygiene Education

Eligibility Criteria

• Age: 20 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Ching-Hsia Hung, PhD

  National Cheng Kung University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Ting Wu

CONTACT

+886-973501203; wuyiting1224@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: August 28, 2026
• First Posted: September 2, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 22, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)