NCT02324790

Pilot Study of Negative Pressure Sleep Therapy System to Treat Obstructive Sleep Apnea

A Multicenter Pilot Study on the Indications of Negative Pressure Sleep Therapy System for the Treatment of Obstructive Sleep Apnea (OSA)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Somnics, Inc. · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot study to investigate the efficacy and safety of the Negative Pressure Sleep Therapy System for the treatment of obstructive sleep apnea.

Detailed description

This is an open-lable, single-arm, evaluator-blind and prospective study aimed to evaluate the feasibility of the Negative Pressure Sleep Therapy System for the treatment of obstructive sleep apnea.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	iNAP® Sleep Therapy System	The iNAP® Sleep Therapy System provides pressure gradient within the oral cavity to pull the tongue toward upper palate and the soft palate forward, which aims to maintain better upper airway patency near the pharynx to prevent sleep-disordered breathing.

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-01-13
• Completion: 2016-01-13
• First posted: 2014-12-24
• Last updated: 2018-03-19

Locations

4 sites across 1 country: Taiwan