SnoringSILENCENCT03083106
Snoring Intervention Via Elevoplasty in a Non-surgical Clinical Environment
A study testing Elevoplasty in people with Snoring, run by Zelegent, Inc. at 6 sites in United States.
Trial summary
Single Group Compared to Baseline, Non-Randomized, Multi-Center, Prospective Safety \& Efficacy Study Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Snoring
- What is being tested?
- Elevoplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 6 sitesUnited States
- Study dates
- 3 Mar 2017to 29 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
St. Elizabeth's Medical Center
Brighton, Massachusetts, 02135
Medical University of South Carolina
Charleston, South Carolina, 29425
ChicagoENT (*Note: it's important to capitalize the "ENT")
Chicago, Illinois, 60657
Park Avenue Sinus & Sleep Center
New York, New York, 10016
Entrust Medical Group
Orange, California, 92868
Staten Island University Hospital
Staten Island, New York, 10305
About this study
Single Group Compared to Baseline, Non-Randomized, Multi-Center, Prospective Safety \& Efficacy Study
Read the 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.
- Conditions
- Snoring
- Being tested
- Elevoplasty
- Medical subject headings
- Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Elevoplasty treatment | Other | Single Group Compared to Baseline, Non-Randomized, Multi-Center, Prospective Receives: Device: Elevoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: Thirty (30) days post device intervention
Secondary outcomes (2)
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".
Measured: 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".
Measured: One hundred eighty (180) days post device intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start3 Mar 2017
- Primary completion29 Sep 2017
- Study completion29 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SnoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Compared to Baseline, Non-Randomized, Multi-Center, Prospective Safety \& Efficacy Study
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zelegent, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter J. Catalano, MD, Principal investigator, St. Elizabeth's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083106
- Sponsor's protocol ID
- GCP002-001
- Acronym
- SILENCE
- Status last verified
- Mar 2017
- First submitted
- 3 Mar 2017
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will remain confidential to the Investigators and to the Sponsor
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Snoring Intervention Via Elevoplasty in a Non-surgical Clinical Environment
- ClinicalTrials.gov ID
- NCT03083106
- Acronym / sponsor ID
- SILENCE / GCP002-001
- Conditions
- Snoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Zelegent, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 29 Sep 2017 (actual)
- Study completion
- 29 Sep 2017 (actual)
- First posted
- 17 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Compared to Baseline, Non-Randomized, Multi-Center, Prospective Safety \& Efficacy Study
| Arm | Type | Receives |
|---|---|---|
| Elevoplasty treatment | Other | Device: ElevoplastySingle Group Compared to Baseline, Non-Randomized, Multi-Center, Prospective |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElevoplastyThe 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. | Device | Elevoplasty treatment |
Primary outcome
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").
Time frame: 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".
2 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").
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").
Time frame: One hundred eighty (180) days post device intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
- Individual participant dataSharing planned: No. IPD will remain confidential to the Investigators and to the Sponsor
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter J. Catalano, MD principal investigator
St. Elizabeth's Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elevoplasty in people with Snoring, run by Zelegent, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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"). (time frame: Thirty (30) days post device intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2020.