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It was aimed to investigate the effect of expiratory muscle strength training (EMST) applied at different intensities on systemic inflammation and oxidative stress in patients with moderate obstructive sleep apnea syndrome (OSAS). In the study, 32 male patients diagnosed with moderate OSAS will be included in the study. Participants will then be divided into 2 groups by block randomization. In the three-blind planned study; the first group will receive high-intensity %60 maximum expiratory pressure (MEP) EMST training, and the second group will be given low-intensity 30% of MEP, EMST training for 12 weeks. Disease-related symptoms, disease severity apnea-hypopnea index (AHI), oxidative stress index (OSI) and systemic inflammation level, exercise capacity, respiratory muscle strength, sleep quality, daytime sleepiness, and fatigue severity will be evaluated before and after the study.
Primary outcome measures are; disease severity, oxidative stress index and systemic inflammation.
Secondary outcome measurements are; disease-related symptoms, exercise capacity, respiratory muscle strength, sleep quality, daytime sleepiness, and severity of fatigue.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| H-EMST | Experimental | In 60% of the maximum expiratory pressure (MEP), 25 breaths a day, 7 days / week, a total of 12 weeks will be trained with a 1-minute rest cycle in 5 breaths. Patients will be invited to control every 2 weeks. MEP measurements will be repeated and the training value will be adjusted in 60% of the new measurement. |
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| L-EMST | Experimental | At 30% of the maximum expiratory pressure (MEP), 25 breaths, 7 days / week, a total of 12 weeks will be trained once a day with a 1-minute rest cycle in 5 breaths. Patients will be invited to control every 2 weeks. MEP measurements will be repeated and the training value will be adjusted in 30% of the new measurement. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Expiratory muscle trainig | Other | This exercise will be used to strengthen forced expiratory muscles. |
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| Measure | Description | Time Frame |
|---|---|---|
| Disease severity | Polysomnography recordings will be taken especially sleep efficiency and apnea-hypopnea index (AHI). Higher sleep efficiency and lower AHI values shows that patient have better status and lower disease severity | 2 days |
| Oxidative stress-1 | TAS:Venous blood sample will be taken from the forearms of the patients in a 5 mL gel biochemistry tube with serum separator between 8.00-11.00 in the morning after an overnight fast and will be analyzed with a colorimetric kit. | 5 days |
| Systemic inflammation-1 | CRP:biochemistry laboratory will work on the Abbott Architect C4000 (USA) clinical chemistry autoanalyzer. | 5 days |
| Systemic inflammation-2 | TNF-a:After an overnight fast, venous blood samples will be taken from the forearms of the patients in a 5 mL gel biochemistry tube with serum separator between 8.00-11.00 in the morning and analyzed with the ELISA kit. | 5 days |
| Systemic inflammation-3 | IL10:After an overnight fast, venous blood samples will be taken from the forearms of the patients in a 5 mL gel biochemistry tube with serum separator between 8.00-11.00 in the morning and analyzed with the ELISA kit. | 5 days |
| Systemic inflammation-4 | IL-6:After an overnight fast, venous blood samples will be taken from the forearms of the patients in a 5 mL gel biochemistry tube with serum separator between 8.00-11.00 in the morning and analyzed with the ELISA kit. | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise capacity | 6 minute walking testing (6MWT):The primary outcome is the distance covered in meters or converted measure (such as feet) over 6 minutes. To measure functional aerobic capacity or general fitness, this test may be used in conjunction with VO2 testing. | 2 days |
| Maximal inspiratory and expiratory muscle strength |
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Inclusion Criteria:
5) Patients who do not have a mental problem that will prevent cooperation will be included.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adem Çelik, MD | Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital | Study Chair |
| Sevim Kahraman Yaman, MD | Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital | Study Chair |
| Hüseyin Yaman, MD | Karadeniz Technical University | Study Chair |
| Nurel Erturk, MsC | Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital | Principal Investigator |
| Ebru Çalık Kütükçü, PhD | Hacettepe University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital | Ortahi̇sar | Trabzon | 61100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39297486 | Derived | Erturk N, Celik A, Kahraman Yaman S, Yaman H, Unal F, Calik Kutukcu E. Expiratory muscle strength training reduces oxidative stress and systemic inflammation in men with obstructive sleep apnea syndrome: a double-blinded, randomized parallel trial. Sleep. 2024 Dec 11;47(12):zsae221. doi: 10.1093/sleep/zsae221. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Oxidative stress-2 | TOS:Venous blood sample will be taken from the forearms of the patients in a 5 mL gel biochemistry tube with serum separator between 8.00-11.00 in the morning after an overnight fast and will be analyzed with a colorimetric kit. | 5 days |
Maximal inspiratory and expiratory muscle strength will be evaluated with mouth pressure device. |
| 2 days |
| Daytime sleepiness | Epworth Sleepiness Scale . Minimum and maximum scores: 0-24. The higher Epworth Sleepiness Scale score means the higher that person's average sleep propensity in daily life , or their 'daytime sleepiness' | 2 days |
| Fatigue severity. | Fatigue Severity Scale (FSS)Minimum and maximum scores: 0-7. FSS scores higher than 4 shows high intensity fatigue perception | 2 days |
| Sleep quality | The Pittsburgh Sleep Quality Index (PSQI). Minimum and maximum scores: 0-21. Higher PSQI scores show worse sleep quality. | 2 days |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |