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

OSA Clinical Trial

Official title:

Thoracic Department, Chang Gung Memorial Hospital, Linko Main Branch

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04626700
• Other study ID #: 201802177A3
• Status: Recruiting
• Phase: N/A
• Start date: August 14, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2020
• Source: Chang Gung Memorial Hospital
• Contact: Tsai-Yu Wang, MD
• Phone: +886975368076
• Email: wang5531[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• DISE
• iNAP
• OSA

Intervention

Device:
• iNAP
iNAP for the treatment of OSA
• CPAP
CPAP for the treatment of OSA

Locations

Country	Name	City	State
Taiwan	Division of Thoracic Medicine, Chang Gung Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Epworth Sleepiness Scale (ESS)	lower ESS means better outcome	Change from Baseline ESS at 1 month
Primary	The Epworth Sleepiness Scale (ESS)	lower ESS means better outcome	Change from Baseline ESS at 2 months
Primary	apnea-hypopnea index (AHI)	lower AHI means better outcome	Change from Baseline AHI at 2 months