Pivotal Study of the iNAP® in Adults With OSA

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: iNAP® Sleep Therapy System

• Registration Number: NCT03544463
• Lead Sponsor: Somnics, Inc.

Brief Summary

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)

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, 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.

Study Timeline

• Study First Submitted: 2018-03-15
• Study First Submitted QC: 2018-05-21
• Study First Posted: 2018-06-01
• Study Start: 2018-06-06
• Primary Completion: 2018-09-01
• Study Completion: 2018-11-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treated	iNAP® Sleep Therapy System	iNAP® Sleep Therapy System Treatment Intervention

Primary Outcome Measures

Name	Time	Method
iNAP®-treated response rate over the apnea-hypopnea index (AHI)*	first treatment night	\*AHI is the number of apnea/hypopnea events divided by total sleep time (TST), i.e., the number of hours of sleep. The reduction rate of AHI is calculated by dividing the AHI reduction on the Tx PSG Study when compared to the Baseline PSG Study with individual baseline AHI. An AHI reduction rate of 50% is considered responsive, namely, responder. Therefore, an overall ratio of responder to the primary endpoint cohort is the response rate.

Secondary Outcome Measures

Name	Time	Method
Negative pressure maintenance time (hr)	first treatment night	The time period of iNAP® in providing effective negative pressure within the oral cavity
Change of Oxygen Desaturation Index (ODI)** from the Baseline PSG Study compared to the Tx PSG Study	first treatment night	\*\*ODI is the event number of oxygen level drops by 3 percent or more from baseline divided by total sleep time (TST), i.e., the number of hours of sleep.
Clinical Global Impression of Change (CGI-C)	first treatment night	Global impression changes as rated by the physicians

Trial Locations

Locations (1)

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