Snoring Intervention Via Elevoplasty in a Non-surgical Clinical Environment (SILENCE)

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

Study Overview

• Status: Completed
• Conditions: Snoring
• Intervention / Treatment: Device: Elevoplasty

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • Entrust Medical Group
  • Illinois
    • Chicago, Illinois, United States, 60657
      • ChicagoENT (*Note: it's important to capitalize the "ENT")
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135
      • St. Elizabeth's Medical Center
  • New York
    • New York, New York, United States, 10016
      • Park Avenue Sinus & Sleep Center
    • Staten Island, New York, United States, 10305
      • Staten Island University Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Elevoplasty treatment; Single Group Compared to Baseline, Non-Randomized, Multi-Center, Prospective	Device: Elevoplasty; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean within-subject change in SNAP Diagnostics Home Sleep Study (HSS) Measure #1 from pre-treatment with the device ("Elevo Kit") to post-treatment with the device ("Elevo Kit").	Difference between the two following parameters: (1) Percent (%) of snoring events comprised of the sum of types (I + II) and comprised of the sum of types (III + IV + WL) pre-treatment (2) Percent (%) of snoring events comprised of the sum of types (I + II) and comprised of the sum of types (III + IV + WL) post-treatment. Key to Snoring Event Types (as categorized by SNAP Diagnostics, Inc.) Type I: Mostly Palate Type II: Mostly Palate + tongue Type III: Sound, but no particular pattern, can originate from lungs or from upper airway Type IV: High pitch, more diffuse, similar to asthma Type WL: Wheezing-like. Resulting value of Measure #1 is in percents (%). Note: Measure #1 will be repeated via Home Sleep Study at Day 90 post-treatment and will be repeated via Home Sleep Study at Day 180 post-treatment.	Thirty (30) days post device intervention
Mean within-subject change in SNAP Diagnostics Home Sleep Study (HSS) Measure #2 from pre-treatment with the device ("Elevo Kit") to post-treatment with the device ("Elevo Kit").	Difference between the two following parameters: (1) Average loudness ratio (loudness is measured in decibels [dB]) of events comprised of the sum of types (I + II) and comprised of the sum of types (III + IV + WL) pre-treatment (2) Average loudness ratio of events comprised of the sum of types (I + II) and comprised of the sum of types (III + IV + WL) post-treatment. Key to Snoring Event Types (as categorized by SNAP Diagnostics, Inc.) Type I: Mostly Palate Type II: Mostly Palate + tongue Type III: Sound, but no particular pattern, can originate from lungs or from upper airway Type IV: High pitch, more diffuse, similar to asthma Type WL: Wheezing-like. Resulting value of Measure #2 is an absolute number. Note: Measure #2 will be repeated via Home Sleep Study at Day 90 post-treatment and will be repeated via Home Sleep Study at Day 180 post-treatment.	Thirty (30) days post device intervention
Mean within-subject change of Pittsburgh Sleep Quality Index (PSQI) from pre-treatment with the device ("Elevo Kit") to post-treatment with the device ("Elevo Kit").	Difference between the two following parameters: (1) PSQI Score pre-treatment (2) PSQI Score post-treatment. Resulting value is an absolute number. The PSQI is a self-report (i.e., patient-reported outcome) questionnaire that is comprised of nineteen (19) individual items that create seven (7) components that produce one (1) global score. The PSQI takes 5 - 10 minutes to complete. Note: the PSQI questionnaire will be repeat-administered at Day 90 post device intervention and will be repeat-administered at Day 180 post device intervention.	Thirty (30) days post device intervention
Mean within-subject change of Epworth Sleepiness Scale (ESS) from pre-treatment with the device ("Elevo Kit") to post-treatment with the device ("Elevo Kit").	Difference between the two following parameters: (1) ESS Score pre-treatment (2) ESS Score post-treatment. Resulting value is an absolute number. The ESS is a self-report (i.e., patient-reported outcome) scale that is intended to measure daytime sleepiness and that is measured by use of a very short questionnaire. Note: the ESS questionnaire will be repeat-administered at Day 90 post device intervention and will be repeat-administered at Day 180 post device intervention.	Thirty (30) days post device intervention

Collaborators and Investigators

• Sponsor: Zelegent, Inc.
• Investigators: Principal Investigator: Peter J. Catalano, MD, St. Elizabeth's Medical Center

Publications and helpful links

Helpful Links

• Sponsor Website

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2017
• Primary Completion (Actual): September 29, 2017
• Study Completion (Actual): September 29, 2017

Study Registration Dates

• First Submitted: March 3, 2017
• First Submitted That Met QC Criteria: March 12, 2017
• First Posted (Actual): March 17, 2017

Study Record Updates

• Last Update Posted (Actual): January 30, 2020
• Last Update Submitted That Met QC Criteria: January 28, 2020
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Respiratory Sounds; Snoring
• Other Study ID Numbers: GCP002-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPD will remain confidential to the Investigators and to the Sponsor

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No