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Pivotal Study of the iNAP® in Adults With OSA

NCT03544463 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-04-04

No results posted yet for this study

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)

Conditions

Interventions

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.

Sponsors & Collaborators

  • Somnics, Inc.

    lead INDUSTRY

Principal Investigators

  • Chia-Mo Lin · Shin Kong Wu Ho-Su Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-06
Primary Completion
2018-09-01
Completion
2018-11-01

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03544463 on ClinicalTrials.gov