In-Home Study of Intraoral Device for Reducing Snoring Among Habitual Snorers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Zyppah, Inc.
- 入组人数
- 604
- 试验地点
- 2
- 主要终点
- Snoring Severity Scale
研究概览
简要总结
Online patient registration to participate in clinical trial to test OTC mouthpiece that controls position of the tongue to reduce snoring.
详细描述
Patient will complete informed consent, inclusion/exclusion criteria, sleep apnea and snoring surveys online. If patient meets all criteria for the study, patient will be provided with a treatment device for use for a 10 day treatment period. Patient will complete the trial upon providing final online surveys.
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
- Double (Care Provider, Investigator)
盲法说明
The data is compiled and analyzed by an outside, independent organization
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Over 18 years of age
- •Living in the United States
- •Signing the Informed Consent Form
排除标准
- •Missing teeth (as the device won't be properly fitted)
- •Any severe breathing or respiratory disorder, such as chronic asthma, emphysema, COPD, or a similar condition
- •Poor dental health, such as severe gum disease, loose teeth, an abscess, mouth sores, or bleeding gums
- •A dental implant placed within the last three months
- •Diagnosed with a Temporomandibular joint condition (TMJ)
- •Actively experiencing any mouth or jaw pain, including clenching of the teeth, grinding, or any other physical injury to the jaw or teeth
- •Full dentures
- •Diagnosis of sleep apnea
- •Less than 18 years of age
结局指标
主要结局
Snoring Severity Scale
时间窗: Baseline and 10 Days
The Snoring Severity Scale (SSS) is a 9-point, validated scale to measure the severity of snoring. A total of three questions are asked: 1) "How often do you snore, 2) "How long do you snore", and 3) How audible is your snoring. Answers for each of these questions are summed for a total SSS score. A score of '0' would indicate no snoring at all, while a score of '9' would indicate the most severe snoring as measured by the SSS. Outcome measure reported as change with use of the device over pre-trial. In this case, a negative ('-') would represent improvement in snoring symptoms, while a positive ('+') number would indicate an increase in snoring severity.
Visual-Analogue Scale, Self-Reported Snoring Habits
时间窗: Baseline and 10 Days
Quantitative assessment on 1-10 scale. Outcome measurement reported as a percentage change from pre-trial with use of the device. A negative ('-') percentage would indicate a reduction in snoring symptoms as measured by the VAS, while a positive percentage ('+') result would indicate an increase in the measured symptom.
次要结局
未报告次要终点