Snoring Intervention Via Elevoplasty in a Non-surgical Clinical Environment

Not Applicable

Completed

• Conditions: Snoring
• Interventions: Device: Elevoplasty

• Registration Number: NCT03083106
• Lead Sponsor: Zelegent, Inc.

Brief Summary

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

Detailed Description

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 Timeline

• Status Verified: 2017-03
• Study Start: 2017-03-03
• Study First Submitted: 2017-03-03
• Study First Submitted QC: 2017-03-12
• Study First Posted: 2017-03-17
• Primary Completion: 2017-09-29
• Study Completion: 2017-09-29
• Last Update Submitted: 2020-01-28
• Last Update Posted: 2020-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Elevoplasty treatment	Elevoplasty	Single Group Compared to Baseline, Non-Randomized, Multi-Center, Prospective

Primary Outcome Measures

Name	Time	Method
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").	Thirty (30) days post device intervention	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".

Secondary Outcome Measures

Name	Time	Method
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").	One hundred eighty (180) days post device intervention	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".

Trial Locations

Locations (6)

ChicagoENT (*Note: it's important to capitalize the "ENT"); 🇺🇸 Chicago, Illinois, United States

Staten Island University Hospital; 🇺🇸 Staten Island, New York, United States

Park Avenue Sinus & Sleep Center; 🇺🇸 New York, New York, United States

St. Elizabeth's Medical Center; 🇺🇸 Brighton, Massachusetts, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Entrust Medical Group; 🇺🇸 Orange, California, United States