Use of Intraoral Device to Treat Snoring, Sleep Apnea, and Other Symptoms of Sleep-Disordered Breathing in Children
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 8
- 主要终点
- Sleep Study
研究概览
简要总结
The clinical hypothesis of this study is that a currently marketed mouthguard may also be able to reduce the symptoms of sleep-disordered breathing in children.
详细描述
The purpose of this study is to evaluate the safety and efficacy of an mouthguard (Vivos Grow/Vivos Way) to reduce sleep-disordered breathing (SDB) in children, including:
snoring, mild to moderate obstructive sleep apnea (OSA), and upper airway resistance syndrome (UARS) in children.
The subjects enrolled in this study will be using the Vivos Grow/Vivos Way to correct orthodontic issues and must also present with signs of SDB.
The study will recruit pediatric subjects who have already elected to utilize the study device for their orthodontic treatment; if they meet the inclusion and exclusion criteria they can be included in the study.
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
盲法说明
No masking is possible, as each child will serve as their own control in using the mouthguard, and their progress will be compared to their measurements prior to beginning the trial.
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over the age of 6 and under the age of 18 years
- •Permanent dentition or mixed dentition at time of evaluation
- •Diagnosis of sleep-disordered breathing (including snoring, upper airway resistance syndrome, and/or mild to moderate obstructive sleep apnea)
- •Have chosen to have orthodontic treatment
- •Living in the United States
- •Signed Informed Consent Form
排除标准
- •Poor oral hygiene
- •Uncontrolled diabetes
- •Severe obstructive sleep apnea (AHI> 10/hr)
- •Enlarged tonsils of a Grade 4 (>75% of space between pillars)
- •Diagnosed with a Temporomandibular join condition (TMJ)
- •Any severe breathing or respiratory disorder, such as chronic asthma, emphysema, COPD, or a similar condition
- •Orthodontic braces in situ
结局指标
主要结局
Sleep Study
时间窗: An initial evaluation before treatment and upon completion of the study (an average of 1 year)
A home sleep study before and after treatment to assess any changes in sleep disturbance.
Pediatric Sleep Questionnaire
时间窗: An initial evaluation before treatment and upon completion of the study (an average of 1 year)
Validated questionnaire for determining sleep-related breathing disorders, snoring, and behavior in childrne. The change in score on the PSQ will be assessed. It is scored from 0-1 with higher scores indicating increased symptoms of sleep disturbance and sleep-disordered breathing. Each question is tallied and an average of all answers (from 3 different subsections) gives the final score.
次要结局
- Sleep Related Breathing Disordered Questionnaire (SRBD)(An initial evaluation before treatment and upon completion of the study (an average of 1 year))
- Airway Volume(An initial evaluation before treatment and upon completion of the study (an average of 1 year))