Comparison for Oral Negative Pressure Therapy and CPAP for OSA Under Sleep Endoscopy Assistance: A Randomized Controlled Trial

Chang Gung Memorial Hospital60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

OSA iNAP DISE

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The Epworth Sleepiness Scale (ESS)

lower ESS means better outcome

Time frame: Change from Baseline ESS at 1 month

The Epworth Sleepiness Scale (ESS)

lower ESS means better outcome

Time frame: Change from Baseline ESS at 2 months

apnea-hypopnea index (AHI)

lower AHI means better outcome

Time frame: Change from Baseline AHI at 2 months