NCT04626700

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

Thoracic Department, Chang Gung Memorial Hospital, Linko Main Branch

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• OSA
• iNAP
• DISE

Interventions

Type	Name	Description
DEVICE	iNAP	iNAP for the treatment of OSA
DEVICE	CPAP	CPAP for the treatment of OSA

Timeline

• Start date: 2019-08-14
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2020-11-12
• Last updated: 2020-11-12

Locations

1 site across 1 country: Taiwan