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The purpose of this study is to investigate the feasibility and effect of a 12-week remotely-supervised rehabilitation program in male patients between 25-65 years old with newly diagnosed obstructive sleep apnea with Apnea-Hypopnea Index greater than 15 episodes per hour indicated to CPAP therapy.
The intervention group will undergo comprehensive remotely-supervised rehabilitaiton program in home conditions with teleconsultation (contains telecoaching, telemonitoring) via regular phone calls and e-mails at least 2 times a week. The intervention will include nutrition, health-related lifestyle and behavioral changes recommendations, and at least 5 times a week 30 minutes of moderate-intensity aerobic training, 10 minutes of inspiratory and expiratory muscle training with breathing device and 10 minutes of oropharyngeal exercise along with individually titrated CPAP therapy.
The control group will undergo individually titrated CPAP therapy only. The participants in both groups will go through the following assessments before and after this study: polysomnography, spirometry, anthropometry and body composition examination, laboratory values examination, quality of life questionnaires, Epworth sleepiness scale, 6-min walking test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Participants will undergo 12-week comprehensive remotely-supervised rehabilitation program along with individually titrated CPAP therapy. |
|
| Control group | No Intervention | Participants will undergo individually titrated CPAP therapy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remotely-supervised rehabilitation program | Other | Include nutrition, health-related lifestyle and behavioral changes recommendations, and at least 5 times a week 30 minutes of moderate-intensity aerobic training, 10 minutes of inspiratory and expiratory muscle training with breathing device and 10 minutes of oropharyngeal exercise along with individually titrated CPAP therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Apnea-Hypopnea Index at Week 12 | Measure will be taken from Polysomnography. Index shows number of apneic or hypopneic periods with duration at least 5 seconds in one hour. Higher Index means worse outcome. | Baseline and Week 12 |
| Change from Baseline in Epworth Sleepiness Scale Score at Week 12 | ESS Score is validated, self-reported instrument of patient's perception of obstructive sleep apnea. Possible scores range is from 0 to 24 points. Higher score means worse outcome. | Baseline and Week 12 |
| Change from Baseline in SF-36 Questionnaire Score at Week 12 | SF-36 Score is validated, self-reported instrument of patient's perception of health state and quality of life. Possible scores range is from 0 to 100 points. Higher score means better outcome. | Baseline and Week 12 |
| Changes from Baseline in Body composition at Week 12 | Measure will be taken from InBody 370. | Baseline and Week 12 |
| Change from Baseline in 6 Minutes Walking Test at Week 12 | 6MWT will be evaluated on flat 30 metres long track marked with two cones. Longer distance means better outcome. | Baseline and Week 12 |
| Change from Baseline in Maximal Inspiratory Pressure at Week 12 | Participants will make 3-5 attempts with 1 minute pause between them. Noted will be the highest score. Higher score means better outcome. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Oxygen Desaturation Index at Week 12 | Measure will be taken from Polysomnography. ODI means number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline. | Baseline and Week 12 |
| Change from Baseline in Neck/Waist/Hip circumferences at Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Brno | Brno | 625 00 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37721786 | Derived | Hnatiak J, Zikmund Galkova L, Winnige P, Batalik L, Dosbaba F, Ludka O, Krejci J. Obstructive Sleep Apnea and a Comprehensive Remotely Supervised Rehabilitation Program: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Sep 18;12:e47460. doi: 10.2196/47460. |
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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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|
| Change from Baseline in Maximal Expiratory Pressure at Week 12 |
Participants will make 3-5 attempts with 1 minute pause between them. Noted will be the highest score. Higher score means better outcome. |
| Baseline and Week 12 |
All circumferences will be measured by tape measure. |
| Baseline and Week 12 |
| Change from Baseline in Body Mass Index at Week 12 | BMI will be calculated of participant's current weight and height. | Baseline and Week 12 |
| Change from Baseline in Forced Vital Capacity at Week 12 | Measure will be taken from Spirometry. | Baseline and Week 12 |
| Change from Baseline in Forced Expiratory Volume in 1 Second at Week 12 | Measure will be taken from Spirometry. | Baseline and Week 12 |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |