Pivotal Study of the iNAP® in Adults With OSA

Status Completed

Clinical Trial Summary

A Prospective, Self-controlled, First-night Order Cross-over and Evaluator-blind Pivotal Study to Evaluate the Efficacy and Safety of iNAP® Sleep Therapy System in Adults with Obstructive Sleep Apnea (OSA)

Clinical Trial Description

Obstructive sleep apnea (OSA) impacts sleep quality of patients, which contributes significantly to hypertension, stroke, myocardial infarction and other health problems. Intraoral devices, such as tongue retaining devices, palatal lifting devices and mandibular repositioning devices designed to increase the patency of the airway and to decrease airway obstruction, are used to treat OSA. To this end, the investigators are conducting a prospective, self-controlled, first-night order cross-over and evaluator-blind pivotal study to evaluate the efficacy and safety of iNAP® Sleep Therapy System (iNAP®), a tongue and soft palate retaining intraoral device, in adults with OSA. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03544463
Study type	Interventional
Source	Somnics, Inc.
Contact
Status	Completed
Phase	N/A
Start date	June 6, 2018
Completion date	November 1, 2018

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