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

Not Applicable

• Conditions: iNAP; DISE; OSA
• Interventions: Device: iNAP; Device: CPAP

• Registration Number: NCT04626700
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-14
• Status Verified: 2020-10
• Study First Submitted: 2020-11-01
• Study First Submitted QC: 2020-11-06
• Last Update Submitted: 2020-11-06
• Study First Posted: 2020-11-12
• Last Update Posted: 2020-11-12
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iNAP	iNAP	-
CPAP	CPAP	-

Primary Outcome Measures

Name	Time	Method
apnea-hypopnea index (AHI)	Change from Baseline AHI at 2 months	lower AHI means better outcome
The Epworth Sleepiness Scale (ESS)	Change from Baseline ESS at 2 months	lower ESS means better outcome

Trial Locations

Locations (1)

Division of Thoracic Medicine, Chang Gung Memorial Hospital; 🇨🇳 Taipei, Taiwan