DISE, iNAP, OSA
Conditions
Brief summary
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.
Interventions
DEVICEiNAP
iNAP for the treatment of OSA
DEVICECPAP
CPAP for the treatment of OSA
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* mild to moderate OSA
Exclusion criteria
* hypopharynx obstruction * ASA classification of physical status)\>3 * allergy toDexmedetomidine * COPD stage IV * Asthma with exacerbation * severe CHF * age \< 18 year-old * claustraphobia * any reason : can not tolerate CPAP * second or third degree AVB
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Epworth Sleepiness Scale (ESS) | Change from Baseline ESS at 1 month | lower ESS means better outcome |
| apnea-hypopnea index (AHI) | Change from Baseline AHI at 2 months | lower AHI means better outcome |
Countries
Taiwan
Contacts
Primary ContactTsai-Yu Wang, MD
Outcome results
None listed