Pivotal Study of the iNAP® in Adults With OSA

Somnics

Status

Completed

Conditions

Obstructive Sleep Apnea

Treatments

Device: iNAP® Sleep Therapy System

Study type

Interventional

Funder types

Industry

Identifiers

NCT03544463

iNAP®-TW-1701

Details and patient eligibility

About

A Prospective, Self-controlled, First-night Order Cross-over and Evaluator-blind Pivotal Study to Evaluate the Efficacy and Safety of iNAP® Sleep Therapy System in Adults with Obstructive Sleep Apnea (OSA)

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, the investigators are conducting a prospective, self-controlled, first-night order cross-over and evaluator-blind pivotal study to evaluate the efficacy and safety of iNAP® Sleep Therapy System (iNAP®), a tongue and soft palate retaining intraoral device, in adults with OSA.

Enrollment

32 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients able to read and sign on the informed consent form and able to comply with study requirements.
Body mass index (BMI) <33 kg/m2
AHI between 15~55
Pass a device feasibility test

Exclusion criteria

Obstructed nasal passages
Hypoxemia (SpO2 <80%)
Primary insomnia or other suspected sleep disorder other than OSA
Muscle diseases, e.g. CSA
Patients with potential complications of sleep apnea that, in the opinion of the Investigator, may affect the study interpretation or the health or safety of the patients