The Impact of Exercise on Irisin-BDNF Regulation in Obstructive Sleep Apnea
NCT07799753, Not applicable, Not yet recruiting, National Cheng-Kung University Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | The Impact of Exercise on Irisin-BDNF Regulation in Obstructive Sleep Apnea | ClinicalTrials.gov |
| NCT number | NCT07799753 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 50 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | National Cheng-Kung University Hospital | ClinicalTrials.gov |
| Conditions | Obstructive Sleep Apnea | ClinicalTrials.gov |
| Interventions | Supervised Aerobic Exercise, Sleep Hygiene Education | ClinicalTrials.gov |
| First posted | 2026-09-02 | ClinicalTrials.gov |
| Last updated | 2026-09-22 | ClinicalTrials.gov |
Registered outcomes 22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Apnea-Hypopnea Index (AHI) | 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. | ClinicalTrials.gov |
| Primary | Change in Oxygen Desaturation Index (ODI) | 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. | ClinicalTrials.gov |
| Primary | Change in Irisin Level | 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. | ClinicalTrials.gov |
| Primary | Change in Brain-Derived Neurotrophic Factor (BDNF) Level | 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. | ClinicalTrials.gov |
| Secondary | Change in Sleep Efficiency | Baseline and Week 4 | 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. | ClinicalTrials.gov |
| Secondary | Change in Arousal Index | Baseline and Week 4 | 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. | ClinicalTrials.gov |
| Secondary | Change in Blood Interleukin-6 (IL-6) Level | Baseline and Week 4 | 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. | ClinicalTrials.gov |
| Secondary | Change in Blood Interleukin-1 Beta (IL-1β) Level | Baseline and Week 4 | 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. | ClinicalTrials.gov |
| Secondary | Change in Blood Tumor Necrosis Factor-Alpha (TNF-α) Level | Baseline and Week 4 | 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. | ClinicalTrials.gov |
| Secondary | Change in Blood Interleukin-10 (IL-10) Level | Baseline and Week 4 | 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. | ClinicalTrials.gov |
| Secondary | Change in Standard Deviation of Normal-to-Normal Intervals (SDNN) | Baseline and Week 4 | 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. | ClinicalTrials.gov |
| Secondary | Change in Root Mean Square of Successive Differences (RMSSD) | Baseline and Week 4 | 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. | ClinicalTrials.gov |
| Secondary | Change in Low-Frequency to High-Frequency Power Ratio (LF/HF Ratio) | Baseline and Week 4 | 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. | ClinicalTrials.gov |
| Secondary | Change in Digit Symbol Substitution Test (DSST) Performance | Baseline and Week 4 | 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. | ClinicalTrials.gov |
| Secondary | Change in Digit Span Test Performance | Baseline and Week 4 | 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. | ClinicalTrials.gov |
| Secondary | Change in Stroop Color-Word Test Performance | Baseline and Week 4 | 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. | ClinicalTrials.gov |
| Secondary | Change in Trail Making Test Performance | Baseline and Week 4 | 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. | ClinicalTrials.gov |
| Secondary | Change in Epworth Sleepiness Scale (ESS) Score | Baseline and Week 4 | 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. | ClinicalTrials.gov |
| Secondary | Change in Pittsburgh Sleep Quality Index (PSQI) Score | Baseline and Week 4 | 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. | ClinicalTrials.gov |
| Secondary | Change in Peak Oxygen Uptake (VO₂peak) | Baseline and Week 4 | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)