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

Obstructive Sleep Apnea of Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03559322
• Other study ID #: iNAP®-TW-1702
• Status: Recruiting
• Start date: August 1, 2019
• Est. completion date: December 30, 2021

Study information

• Verified date: September 2019
• Source: Somnics, Inc.
• Contact: Chen-Ning Huang, Ph.D.
• Phone: +886-3-550-9623
• Email: HuangCN[@]somnics.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: December 30, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea of Adult
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• iNAP® Lite Sleep Therapy System
Class II intraoral devices for snoring and/or obstructive sleep apnea

Locations

Country	Name	City	State
Taiwan	Shin Kong Wu Ho-Su Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Somnics, Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events in this entire study.	All safety events will be listed and tabulated for their occurrence rate	through study completion, up to 10 weeks
Secondary	iNAP® Lite-treated clinical success rate	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