Snoring Intervention Via Elevoplasty in a Non-surgical Clinical Environment

Completed · Not applicable

Conditions studied: Snoring

In brief

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

Key facts

Study ID

NCT03083106

Run by

Zelegent, Inc.

People needed

52

Starts

2017-03-03

Expected to finish

2017-09-29

Last updated by the study team

2020-01-30

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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