NCT03083106 - Snoring Intervention Via Elevoplasty in a Non-surgical Clinical Environment | Crick

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Enrollment

52

Conditions

Snoring

Interventions

ElevoplastyDEVICE

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.

Eligibility

Sex: ALLMin age: 22 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (6)

Entrust Medical Group

Orange, California, United States

ChicagoENT (*Note: it's important to capitalize the "ENT")

Chicago, Illinois, United States

St. Elizabeth's Medical Center

Brighton, Massachusetts, United States

Park Avenue Sinus & Sleep Center

New York, New York, United States

Outcomes

Primary Outcomes

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".

Time frame: Thirty (30) days post device intervention

Secondary Outcomes

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".

Time frame: 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".