Real World Experiences of the iNAP® Lite in OSA Adults in Taiwan

Last updated: September 19, 2019
Sponsor: Somnics, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sleep Apnea Syndromes

Treatment

N/A

Clinical Study ID

NCT03559322
iNAP®-TW-1702
  • Ages > 18
  • All Genders

Study Summary

A Prospective, Observational, Post-market Surveillance Study to Evaluate the Long-term Safety and Efficacy of the iNAP® Lite Sleep Therapy System in Adults with Obstructive Sleep Apnea

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed with OSA with AHI>5

Exclusion

Exclusion Criteria:

  • Patients with central sleep apnea (CSA).

  • Patients with have severe respiratory disorders such as pulmonary diseases,pneumothorax, etc.

  • Patients with loose teeth or advanced periodontal disease.

  • Patients with pathologically low blood pressure.

Study Design

Total Participants: 76
Study Start date:
August 01, 2019
Estimated Completion Date:
December 30, 2021

Study 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, we are conducting a prospective, observational, post-market surveillance study to evaluate the long-term safety and efficacy of the iNAP® Lite sleep therapy system (iNAP® Lite), a tongue and soft palate retaining intraoral device, in adults with OSA.

Connect with a study center

  • Shin Kong Wu Ho-Su Memorial Hospital

    Taipei, 111
    Taiwan

    Active - Recruiting

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