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

September 19, 2019 updated by: Somnics, Inc.

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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, 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.

Study Type

Observational

Enrollment (Anticipated)

76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 111
        • Recruiting
        • Shin Kong Wu Ho-Su Memorial Hospital
        • Contact:
          • Chia-Mo Lin, M.D.
          • Phone Number: +88628332211

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults with obstructive sleep apnea in Taiwan

Description

Inclusion Criteria:

  • Diagnosed with OSA with AHI>5

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events in this entire study.
Time Frame: through study completion, up to 10 weeks
All safety events will be listed and tabulated for their occurrence rate
through study completion, up to 10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
iNAP® Lite-treated clinical success rate
Time Frame: a treated polysomnography or polygraphy assessment night
AHI is the number of apnea/hypopnea events divided by total sleep time (TST), i.e., the number of hours of sleep. Clinical success rate is defined as the proportion of patients in the PP cohort with an AHI reduction of >50% and treated AHI <20 on the Tx PSG Study when compared with the baseline
a treated polysomnography or polygraphy assessment night

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Somnics, Inc.

Investigators

  • Study Chair: Chung-Chu Chen, Ph.D., Somnics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

December 30, 2021

Study Registration Dates

First Submitted

June 6, 2018

First Submitted That Met QC Criteria

June 6, 2018

First Posted (Actual)

June 18, 2018

Study Record Updates

Last Update Posted (Actual)

September 23, 2019

Last Update Submitted That Met QC Criteria

September 19, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iNAP®-TW-1702

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

May or may not share the results in a publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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