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A Post-marketing Surveillance of the Negative Pressure Sleep Therapy System to Treat Obstructive Sleep Apnea

Obstructive Sleep Apnea (OSA) Clinical Trial

Official title:
A Multi-center, Two-stage, Single-arm, Prospective, First-night Order Cross-over, Evaluator-blind Study to Evaluate the Efficacy, Safety and Tolerance of the iNAP® Sleep Therapy System in Adults With Obstructive Sleep Apnea (OSA)

Clinical Trial Summary

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

Clinical Trial Description

This is a multi-center, two-stage, single-arm, prospective, first-night order cross-over, evaluator-blind, post-marketing surveillance study to evaluate the efficacy, safety and tolerance of the iNAP® Sleep Therapy System (iNAP), a tongue and soft palate retaining intraoral device, in adults with obstructive sleep apnea (OSA). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02698059
Study type Interventional
Source Somnics, Inc.
Contact C.C. Chen, Ph.D.
Email chungchu1@somnics.com
Status Recruiting
Phase N/A
Start date January 22, 2016
Completion date May 2020
View Details
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