Pivotal Study of the iNAP® in Adults With OSA

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: iNAP® Sleep Therapy System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treated<br>iNAP® Sleep Therapy System Treatment Intervention | Device: iNAP® Sleep Therapy System<br>* The iNAP® provides a pressure gradient within the oral cavity, which pulls the tongue toward the upper palate and pulls the soft palate forward in a way that enhances the patency of the upper airway near the pharynx so that upper airway patency can be maintained to prevent sleep-disordered breathing.<br>|
| No Intervention: Baseline/Control<br>Self-controlled, pre-treatment baseline condition | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| iNAP®-treated response rate over the apnea-hypopnea index (AHI)* | *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. | first treatment night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression of Change (CGI-C) | Global impression changes as rated by the physicians | first treatment night | 
| Negative pressure maintenance time (hr) | The time period of iNAP® in providing effective negative pressure within the oral cavity | first treatment night | 
| Change of Oxygen Desaturation Index (ODI)** from the Baseline PSG Study compared to the Tx PSG Study | **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. | first treatment night |