NCT02698059

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

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)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: Somnics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Obstructive Sleep Apnea (OSA)

Interventions

Type	Name	Description
DEVICE	iNAP® Sleep Therapy System (iNAP)	The iNAP 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: 2016-01-22
• Primary completion: 2020-02-18
• Completion: 2020-05-01
• First posted: 2016-03-03
• Last updated: 2020-03-18

Locations

8 sites across 2 countries: Germany, Taiwan