Pilot Study of Negative Pressure Sleep Therapy System to Treat Obstructive Sleep Apnea

NCT02324790 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2018-03-19

No results posted yet for this study

Summary

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

Conditions

Interventions

DEVICE

iNAP® Sleep Therapy System

The iNAP® Sleep Therapy System 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.

Sponsors & Collaborators

  • Somnics, Inc.

    lead INDUSTRY

Principal Investigators

  • C.M. Lin, M.D. · Shin Kong Wu Ho-Su Memorial Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-01-13
Completion
2016-01-13

Countries

  • Taiwan

Study Locations

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Entities

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 NCT02324790 on ClinicalTrials.gov