Obstructive Sleep Apnea of Adult
Conditions
Keywords
obstructive sleep apnea, oropharyngeal rehabilitation, cardiopulmonary rehabilitation
Brief summary
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.
Detailed description
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 (AHI≥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.
Interventions
BEHAVIORALcomprehensive rehabilitation
oropharyngeal rehabilitation, cardiopulmonary rehabilitation, and therapeutic exercise
Sponsors
National Cheng-Kung University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
participants and assessors blinded
Intervention model description
30 participants with moderate or severe OSA (AHI≥15) were randomized into intervention group (N=15) and control group (N=15).
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 35-65 with or without surgery had difficulty accepting or adhering CPAP
Exclusion criteria
* BMI\<32 * Smoking or alcoholism * Severe allergic rhinitis * Stroke history * CVD * Severe restricted or obstructive pulmonary disease * Hypothyroidism * DM or HTN without stable control * Psychiatric disease * Co-existing non-respiratory sleep disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea-hypopea-index | Change from Baseline Apnea-hypopnea-index at 12 weeks | average apnea and hypopnea events per hour during sleep test |
| potential biomarkers of endothelial dysfunction | at 12 weeks | count of ICAM-1, VCAM-1, and NF-κB molecule in plasma serum (%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oropharyngeal muscle function | at 12 weeks | myofunctional scale of genioglossus muscles, mastication muscles, and deglultition muscles |
| Respiratory muscle function | at 12 weeks | PImax(mmH2O), PEmax(mmH2O) |
| Hear rate variability | at 12 weeks | time domain and frequency domain HRV |
Countries
Taiwan
Outcome results
None listed