NCT03544463

Pivotal Study of the iNAP® in Adults With OSA

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Somnics, Inc. · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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)

Detailed 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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	iNAP® Sleep Therapy System	The iNAP® provides a pressure gradient within the oral cavity, which pulls the tongue toward the upper palate and pulls the soft palate forward in a way that enhances the patency of the upper airway near the pharynx so that upper airway patency can be maintained to prevent sleep-disordered breathing.

Timeline

• Start date: 2018-06-06
• Primary completion: 2018-09-01
• Completion: 2018-11-01
• First posted: 2018-06-01
• Last updated: 2019-04-04

Locations

1 site across 1 country: Taiwan