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

NCT02698059 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2020-03-18

No results posted yet for this study

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.

Conditions

  • Obstructive Sleep Apnea (OSA)

Interventions

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.

Sponsors & Collaborators

  • Somnics, Inc.

    lead INDUSTRY

Principal Investigators

  • Hartmut Schneider, M.D. · American Sleep Clinic Frankfurt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-22
Primary Completion
2020-02-18
Completion
2020-05-31

Countries

  • Germany
  • Taiwan

Study Locations

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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 NCT02698059 on ClinicalTrials.gov