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

Primary Purpose

Snoring

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Elevoplasty
Sponsored by
Zelegent, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Snoring

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Entrust Medical Group
  • ChicagoENT (*Note: it's important to capitalize the "ENT")
  • St. Elizabeth's Medical Center
  • Park Avenue Sinus & Sleep Center
  • Staten Island University Hospital
  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Elevoplasty treatment

Arm Description

Single Group Compared to Baseline, Non-Randomized, Multi-Center, Prospective

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

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".
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".

Full Information

First Posted
March 3, 2017
Last Updated
January 28, 2020
Sponsor
Zelegent, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03083106
Brief Title
Snoring Intervention Via Elevoplasty in a Non-surgical Clinical Environment
Acronym
SILENCE
Official Title
Snoring Intervention Via Elevoplasty in a Non-surgical Clinical Environment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 3, 2017 (Actual)
Primary Completion Date
September 29, 2017 (Actual)
Study Completion Date
September 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zelegent, Inc.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Snoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Compared to Baseline, Non-Randomized, Multi-Center, Prospective Safety & Efficacy Study
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elevoplasty treatment
Arm Type
Other
Arm Description
Single Group Compared to Baseline, Non-Randomized, Multi-Center, Prospective
Intervention Type
Device
Intervention Name(s)
Elevoplasty
Intervention Description
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.
Primary Outcome Measure Information:
Title
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").
Description
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 Outcome Measure Information:
Title
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").
Description
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
Title
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").
Description
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
One hundred eighty (180) days post device intervention
Other Pre-specified Outcome Measures:
Title
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").
Description
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.
Time Frame
Thirty (30) days post device intervention
Title
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").
Description
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.
Time Frame
Thirty (30) days post device intervention
Title
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").
Description
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.
Time Frame
Thirty (30) days post device intervention
Title
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").
Description
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.
Time Frame
Thirty (30) days post device intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter J. Catalano, MD
Organizational Affiliation
St. Elizabeth's Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Entrust Medical Group
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
ChicagoENT (*Note: it's important to capitalize the "ENT")
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
St. Elizabeth's Medical Center
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Park Avenue Sinus & Sleep Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Staten Island University Hospital
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will remain confidential to the Investigators and to the Sponsor

Learn more about this trial

Snoring Intervention Via Elevoplasty in a Non-surgical Clinical Environment

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