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

Somnics

Status: Unknown

Conditions: Obstructive Sleep Apnea of Adult

Treatments: Device: iNAP® Lite Sleep Therapy System

Study type: Observational

Funder types: Industry

Identifiers

NCT03559322

iNAP®-TW-1702

Details and patient eligibility

About

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

Full 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.

Enrollment: 76 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.