Clinical trial NCT03083106: Snoring Intervention Via Elevoplasty in a Non-surgical Clinical Environment
Official title: Snoring Intervention Via Elevoplasty in a Non-surgical Clinical Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Snoring
Lead sponsor: Zelegent, Inc.
Sponsor class: INDUSTRY
First posted: 2017-03-17
Enrollment: 52
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Compared to Baseline, Non-Randomized, Multi-Center, Prospective Safety \& Efficacy Study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
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").
timeFrame: Thirty (30) days post device intervention
Secondary outcomes:
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").
timeFrame: Ninety (90) days post device intervention
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").
timeFrame: One hundred eighty (180) days post device intervention
Other outcomes:
measure: 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").
timeFrame: Thirty (30) days post device intervention
measure: 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").
timeFrame: Thirty (30) days post device intervention
measure: 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").
timeFrame: Thirty (30) days post device intervention
measure: 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").
timeFrame: Thirty (30) days post device intervention
Locations:
city: Orange
country: United States
facility: Entrust Medical Group
state: California
city: Chicago
country: United States
facility: ChicagoENT (*Note: it's important to capitalize the "ENT")
state: Illinois
city: Brighton
country: United States
facility: St. Elizabeth's Medical Center
state: Massachusetts
city: New York
country: United States
facility: Park Avenue Sinus & Sleep Center
state: New York
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: St. Elizabeth's Medical Center
name: Peter J. Catalano, MD
role: PRINCIPAL_INVESTIGATOR
References: