Snoring Intervention Via Elevoplasty in a Non-surgical Clinical Environment

Study Overview
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Brief Summary
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Single Group Compared to Baseline, Non-Randomized, Multi-Center, Prospective Safety & Efficacy Study

Detailed Description
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Evaluate the safety and efficacy of the Zelegent, Inc. Elevo™ Kit Snoring Intervention Device (a minimally invasive, barbed, absorbable suture implant) in the reduction of simple snoring through subjective evaluation of snoring and objective snoring sound analysis. The Zelegent, Inc. Elevo™ Kit Snoring Intervention Device is intended to reduce or eliminate simple snoring in the target patient population via minimally invasive implantation of specialized barbed, absorbable sutures in the soft palate for the purpose of stiffening by way of shortening and lifting the soft palate thereby addressing the root cause of snoring.

Official Title
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Snoring Intervention Via Elevoplasty in a Non-surgical Clinical Environment

Conditions
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Snoring

Intervention / Treatment
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* Device: Elevoplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 22 years (no maximum age) Has consistent Bed/Sleep Partner willing to provide Co-Participant Informed Consent Apnea Hypopnea Index (AHI) of < 15 verified by polysomnogram (PSG) or by SNAP® Diagnostics Home Sleep Study (HSS) Has basic computer literacy (e.g., email) and home internet access or smartphone Chronic, simple snoring (verified by Bed/Sleep Partner) No prior surgical treatment for snoring Bed/Sleep Partner willing and capable of providing Informed Consent Exclusion Criteria: Age < 22 years Has no consistent Bed/Sleep Partner Apnea Hypopnea Index (AHI) > 15 indicative of Obstructive Sleep Apnea Intermittent or occasional snoring Body Mass Index (BMI) > 32 kg/m2 Modified Mallampati 3 or 4 Tonsil Grade 3 or 4+ Significant nasal obstruction Previous palatal surgery Current cigarette smoker Known history of coronary artery disease or stroke Chronic obstructive pulmonary disease (COPD) Diabetes (Type I or Type II) non-controlled by medical management Major depression or non-controlled psychiatric illness Drug or alcohol abuse Untreated or poorly controlled hypertension Anticoagulation therapy History of bleeding or clotting disorder Pregnant Female

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: Single Group Compared to Baseline, Non-Randomized, Multi-Center, Prospective Safety & Efficacy Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Elevoplasty treatment<br>Single Group Compared to Baseline, Non-Randomized, Multi-Center, Prospective | Device: Elevoplasty<br>* The Elevo™ Kit Snoring Intervention Device is designed to facilitate deployment of the Elevo™ suture implant into the submucosal tissue of the soft palate via a minimally invasive, outpatient procedure performed by an otolaryngologist in a medical office setting.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean within-subject change in Snoring Visual Analog Scale from pre-treatment with the device (Elevo Kit) to Snoring Visual Analog Scale post-treatment with the device (Elevo Kit). | Difference between the two following parameters: (1) Snoring Visual Analog Scale (VAS) pre-intervention with the device (Elevo Kit) (2) Snoring Visual Analog Scale (VAS) post-intervention with the device (Elevo Kit). Resulting value is in an absolute number i.e., a numeric 1 to 10 response by the sleep/bed partner to the VAS inquiry Please indicate, by selecting a number on the scale below, the loudness of your partner's snoring. A numeric 0 response corresponds to Light Loudness. A numeric 5 response corresponds to Moderate Loudness. A numeric 10 response corresponds to Intense Loudness. | Thirty (30) days post device intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean within-subject change in Snoring Visual Analog Scale from pre-treatment with the device (Elevo Kit) to Snoring Visual Analog Scale post-treatment with the device (Elevo Kit). | Difference between the two following parameters: (1) Snoring Visual Analog Scale (VAS) pre-intervention with the device (Elevo Kit) (2) Snoring Visual Analog Scale (VAS) post-intervention with the device (Elevo Kit). Resulting value is in an absolute number i.e., a numeric 1 to 10 response by the sleep/bed partner to the VAS inquiry Please indicate, by selecting a number on the scale below, the loudness of your partner's snoring. A numeric 0 response corresponds to Light Loudness. A numeric 5 response corresponds to Moderate Loudness. A numeric 10 response corresponds to Intense Loudness. | Ninety (90) days post device intervention | 
| Mean within-subject change in Snoring Visual Analog Scale from pre-treatment with the device (Elevo Kit) to Snoring Visual Analog Scale post-treatment with the device (Elevo Kit). | Difference between the two following parameters: (1) Snoring Visual Analog Scale (VAS) pre-intervention with the device (Elevo Kit) (2) Snoring Visual Analog Scale (VAS) post-intervention with the device (Elevo Kit). Resulting value is in an absolute number i.e., a numeric 1 to 10 response by the sleep/bed partner to the VAS inquiry Please indicate, by selecting a number on the scale below, the loudness of your partner's snoring. A numeric 0 response corresponds to Light Loudness. A numeric 5 response corresponds to Moderate Loudness. A numeric 10 response corresponds to Intense Loudness. | One hundred eighty (180) days post device intervention |