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

• Conditions: Obstructive Sleep Apnea of Adult

• Registration Number: NCT03559322
• Lead Sponsor: Somnics, Inc.

Brief 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

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 Timeline

• Study First Submitted: 2018-06-06
• Study First Submitted QC: 2018-06-06
• Study First Posted: 2018-06-18
• Study Start: 2019-08-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-19
• Last Update Posted: 2019-09-23
• Primary Completion: 2021-08-01
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
iNAP® Lite-treated clinical success rate	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

Trial Locations

Locations (1)

Shin Kong Wu Ho-Su Memorial Hospital; 🇨🇳 Taipei, Taiwan