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

Zelegent

Status: Completed

Conditions: Snoring

Treatments: Device: Elevoplasty

Study type: Interventional

Funder types: Industry

Identifiers

NCT03083106

GCP002-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Elevoplasty treatment

Other group

Description:

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

Treatment:

Device: Elevoplasty