Pilot Study of Negative Pressure Sleep Therapy System to Treat Obstructive Sleep Apnea

Study Overview
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Brief Summary
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This is a pilot study to investigate the efficacy and safety of the Negative Pressure Sleep Therapy System for the treatment of obstructive sleep apnea.

Detailed Description
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This is an open-lable, single-arm, evaluator-blind and prospective study aimed to evaluate the feasibility of the Negative Pressure Sleep Therapy System for the treatment of obstructive sleep apnea.

Official Title
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A Multicenter Pilot Study on the Indications of Negative Pressure Sleep Therapy System for the Treatment of 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: Diagnosis of OSA, based on AHI 10 60 (as assessed per baseline PSG). Subject understands the study protocol and is willing and able to comply with study requirements and sign the informed consent form. BMI ≦ 28. Exclusion Criteria: Poor nasal patency as evidenced by the inability to breathe through the nose with the mouth closed. Oral cavity infection or any other oral or dental condition or problem that would limit subject use of the device. (e.g. dentures, loose tooth/teeth, temporomandibular joint (TMJ) conditions, or any oral or dental condition that the Investigator believes could be exacerbated by the Sleep Therapy System. History of any OSA surgical treatment including uvulopalatopharyngoplasty surgery (UPPP), maxillomandibular advancement surgery (MMA), radio frequency (RF) ablation treatment, palatal stent devices, etc. History of allergic reaction to silicone. Any concomitant diagnosed or suspected sleep or chronic neurological disorders, other than OSA, including insomnia, and central sleep apnea. Currently working nights, rotating night shifts, planned travel across four or more time zones required during study period, or within two weeks prior to study enrollment, or sleep schedule not compatible with sleep lab practices. Current use of medication or other treatment which, in the investigator's opinion, may pose additional risk to the subject or confound the results of the study. Potential sleep apnea complications that, in the opinion of the investigator, may affect the health or safety of the participant, including: low blood oxygen, recent near-miss or prior automobile accident due to sleepiness, reported history of severe cardiovascular disease (including New York Heart Association (NYHA) class III or IV heart failure, CAD with angina or myocardial infarction (MI)/stroke in past 6 months, uncontrolled hypertension or hypotension, cardiac arrhythmias), reported respiratory disorders, or use of medication or other treatment which may pose additional risk to the subject or confound the results of the study. Female subjects who are pregnant or intend to become pregnant during the study period.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Treated with iNAP® Sleep Therapy System on the treatment PSG night. | Device: iNAP® Sleep Therapy System<br>* The iNAP® Sleep Therapy System provides pressure gradient within the oral cavity to pull the tongue toward upper palate and the soft palate forward, which aims to maintain better upper airway patency near the pharynx to prevent sleep-disordered breathing.<br>* Other names: iNAP®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of Apnea-Hypopnea Index (AHI) | The study was terminated. No enough samples for statistical analysis. | One treatment night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of obstructive apnea reduction | The study was terminated. No enough samples for statistical analysis. | One treatment night | 
| Change from baseline of oxygen desaturation index (ODI) | The study was terminated. No enough samples for statistical analysis. | One treatment night | 
| Adverse event (AE)/ serious adverse event (SAE) rate and type | During the entire study period, a total of only 9 events were reported by 8 patients. | From informed consent form obtained to the end of study, average of 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OSA, Oral Pressure Therapy (OPT)