Snoring Intervention Via Elevoplasty in a Non-surgical Clinical Environment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 6
- 主要终点
- 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").
研究概览
简要总结
Single Group Compared to Baseline, Non-Randomized, Multi-Center, Prospective Safety & Efficacy Study
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Elevoplasty treatment
Single Group Compared to Baseline, Non-Randomized, Multi-Center, Prospective
干预措施: Elevoplasty (Device)
结局指标
主要结局
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").
时间窗: 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".
次要结局
- 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").(One hundred eighty (180) 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").(Ninety (90) days post device intervention)