Safety and Efficacy of Different Modes of Er:YAG Laser Treatment for Snoring in Comparison With Placebo
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- NightLase Snoring Questionnaire-Question 1: Snoring severity change from baseline
研究概览
简要总结
Two modes of laser (Er:YAG) treatment for snoring will be compared with sham treatment in a randomized clinical trial.
详细描述
The aim of this study is to evaluate the clinical outcome of snoring treatment using non-ablative Er:YAG laser in comparison with sham laser treatment. Furthermore, to different modes of Er:YAG laser will be compared; a long-pulse mode (LP) and proprietary SMOOTH mode (Fotona, Slovenia).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Sham treatment consists of laser treatment according to the same protocol as active treatment but with no energy applied. Clinical measurements will be performed by an evaluator unaware of group assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed consent form
- •Diagnosis of snoring/apnea including partner information
- •Age greater than 18 years.
- •Apnea-Hypopnea index (AHI) less than
- •No significant nasal stenosis.
- •Bed partner present
排除标准
- •People who refuse to participate in the study
- •Presence of concomitant disorders and/or diseases
- •Infections in the throat
- •current use of photosensitive drugs
- •pregnancy
- •scarring in the throat
- •acute pollen allergies
- •People starting with an extreme diet or weight loss plan
- •Patients who do not want to follow post treatment recommendation concerning food and drinks intake
- •Larynx obstruction (floppy epiglottis)
- •Oropharynx obstruction caused by palatine tonsils (>50%).
结局指标
主要结局
NightLase Snoring Questionnaire-Question 1: Snoring severity change from baseline
时间窗: 6 months
This questionnaire consists of eight questions, assessing the severity of snoring (the first question) and other problems associated with sleep-disordered breathing (questions 2-8). Answers will be graded on 11-point scales (0-10) .
次要结局
- Change in percentage snoring time of total sleep time (%) from baseline.(3 months)
- Change in Quality of life Questionnaire score from baseline(12 months)
- Change from baseline in snoring value(6 months)
- NightLase Snoring Questionnaire-Question 1: Snoring severity change from baseline(1 month)
- Change in snoring time (mean duration of episode in s) from baseline.(3 months)
- NightLase Snoring Questionnaire change from baseline(12 months)
- Change in EpWorth somnolence scale from baseline(12 months)
- Change in Apnea - Hypopnea Index (AHI) from baseline.(3 months)
- Change in O2 saturation (%) from baseline.(3 months)
研究者
Luis Monteiro
DMD, Phd, Auxiliar Professor at the IUCS in Periodontal Surgical Clinic, Oral Pathology and Biopathology
Cooperativa de Ensino Superior, Politécnico e Universitário