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In previous review study, it was hypothesized that a comprehensive rehabilitation can combine both local pharyngeal muscle exercise and systemic cardiopulmonary rehabilitation for the OSA patients with oropharyngeal muscle dysfunction or ventilator drive instability. To develop a comprehensive rehabilitation model is of innovative care strategy in this study.
BACKGROUND: Obstructive sleep apnea (OSA) is a prevalent sleep-related breathing disorder, which was characterized by repetitive events of complete and partial obstructions of the upper airway. The pathogenesis of OSA is interacted by multiple factors, primarily including upper airway (UA) anatomic impairment, ventilatory drive instability, and oropharyngeal muscle dysfunction. However, studies have proven prior oropharyngeal exercise was designed for those OSA patients with oropharyngeal muscle dysfunction. Unlike prior oropharyngeal exercise, comprehensive rehabilitation should emphasize the cardiorespiratory regulation capability in addition to oropharyngeal function.
OBJECTIVES: Therefore, the purpose of this study is to explore both the clinical and biological effects of our comprehensive rehabilitation, we used PSG data as clinical effect and biomarker of inflammation expression as biological effect.
METHODS: Thirty subjects with moderate or severe OSA (AHIā„15) were randomized into intervention group (N=15) and control group (N=15). In intervention group, a 12-week-intervention of out-patient rehabilitation program included oropharyngeal muscle training, threshold respiratory muscle training, and therapeutic exercise.
ANTICIPATED OUTCOMES: The preliminary results would demonstrate promisingly clinical effects and biological effects of our comprehensive rehabilitation model. Therefore, the further studies should emphasize the methods to differentiate diagnosis for the indicated patients with oropharyngeal muscle dysfunction or ventilatory drive instability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group | Experimental | We conducted a twice a week, 12-week-intervention of 'comprehensive rehabilitation' |
|
| control group | No Intervention | We kept the patients for the waiting list until after completing baseline and 12-week measurement |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| comprehensive rehabilitation | Behavioral | oropharyngeal rehabilitation, cardiopulmonary rehabilitation, and therapeutic exercise |
|
| Measure | Description | Time Frame |
|---|---|---|
| Apnea-hypopea-index | average apnea and hypopnea events per hour during sleep test | Change from Baseline Apnea-hypopnea-index at 12 weeks |
| potential biomarkers of endothelial dysfunction | count of ICAM-1, VCAM-1, and NF-ĪŗB molecule in plasma serum (%) | at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Oropharyngeal muscle function | myofunctional scale of genioglossus muscles, mastication muscles, and deglultition muscles | at 12 weeks |
| Respiratory muscle function | PImax(mmH2O), PEmax(mmH2O) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chinghsia Hung, PhD | National Cheng-Kung University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cheng Kung University Hospital | Tainan | 704 | Taiwan |
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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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30 participants with moderate or severe OSA (AHIā„15) were randomized into intervention group (N=15) and control group (N=15).
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participants and assessors blinded
| at 12 weeks |
| Respiratory muscle function | pulmonary function test (FVC%,FEV1%,FEF50%,FIF50%) | at 12 weeks |
| Hear rate variability | time domain and frequency domain HRV | at 12 weeks |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |