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This is the study entitled "Comparison for oral negative pressure therapy and CPAP for OSA under sleep endoscopy assistance: A randomized controlled trial". CPAP is first line golden standard treatment for Obstructive sleep apnea (OSA). However, the overall CPAP compliance is poor. Recent study reveals that oral negative pressure therapy improves apnea severity in OSA patients with good compliance. However, no study is designed to compare oral negative pressure therapy and CPAP for OSA patients. In addition, the effect of oral negative pressure therapy for hypopharynx is unclear. Therefore, we will perform druginduced sleep endoscopy to evaluate upper airway obstruction of OSA patients before treatment. OSA patients will be assigned into oral negative pressure group or CPAP group for 2 months. Sleepiness, sleep quality, residual apnea severity and compliance will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iNAP | Experimental |
| |
| CPAP | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iNAP | Device | iNAP for the treatment of OSA |
| |
| CPAP |
| Measure | Description | Time Frame |
|---|---|---|
| The Epworth Sleepiness Scale (ESS) | lower ESS means better outcome | Change from Baseline ESS at 1 month |
| The Epworth Sleepiness Scale (ESS) | lower ESS means better outcome | Change from Baseline ESS at 2 months |
| apnea-hypopnea index (AHI) | lower AHI means better outcome | Change from Baseline AHI at 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tsai-Yu Wang, MD | Contact | +886975368076 | wang5531@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Tsang-Tang Hsieh, MD | Institutional Review Board Chang Gung Medical Foundation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Thoracic Medicine, Chang Gung Memorial Hospital | Recruiting | Taipei | 105 | Taiwan |
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| Device |
CPAP for the treatment of OSA |
|