The Efficacy of Intra-oral Neuromuscular Stimulation Training on Primary Snoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Reduction in snoring levels greater than 40dB
研究概览
简要总结
Intraoral Neuromuscular Training for Treatment of Snoring
Objective
Studies show that improving pharyngeal muscle tone can ameliorate obstructive sleep apnoea (OSA) and snoring. The study uses an intra-oral stimulation device (SnooZeal) aimed at a population of snorers. The aim of this study is to assess the efficacy of intra-oral neuromuscular stimulation training during wakefulness on snoring.
Methods
This is a prospective study, recruiting up to 200 patients from the sleep clinics.
In this study, subjects will use the intra-oral stimulation device once a day for 20 minutes each time for a period of 6 weeks. During these 6 weeks, subjects will complete a daily diary of the device use and any side effects or adverse events. Partners also complete a daily snoring score.
Subjects will be followed-up for a further 2 weeks after treatment. They will complete Pittsburgh Sleep Quality Index (PSQI) and subjective sleep quality questionnaires for a further 2 weeks. Partners will also complete the post treatment snoring scores. Sleep study will be repeated.
Outcome measures
The objective evaluation will be based on pre- and post-treatment sleep studies, visual analogue scale (VAS) snoring scores, PSQI and subjective sleep quality questionnaire. All side effects and adverse events will be reported and acted upon according to the risk management structure.
详细描述
Aim/ Objective
The aim of this study will be to assess the efficacy of transoral neuromuscular stimulation training during wakefulness on snoring.
Patients and Methods
This is a prospective observational study, recruiting patients from the sleep clinics at the Department of Otorhinolaryngology, Head and Neck Surgery in Queen's Hospital, Barking, Havering and Redbridge University Hospitals National Health Service (NHS) Trust
Sample size planned is up to 200 participants.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and above at entry into study
- •Subjects must have a live-in partner
- •> 6 months history of habitual snoring (>5 days per week)
排除标准
- •Body Mass Index > 35
- •Apnoea-Hypopnoea Index >15
- •Symptomatic nasal pathology
- •Tonsil Hypertrophy (Tonsil size > Grade 2)
- •Tongue or lip piercing
- •Pacemaker or implanted medical electrical devices
- •Previous oral surgery for snoring
- •Relevant facial skeletal abnormalities
- •Certain oral disease/conditions (see Appendix 3)
- •Any criteria that, in the opinion of the investigator, would make the participant unsuitable for the study due to inability to complete required study procedures
结局指标
主要结局
Reduction in snoring levels greater than 40dB
时间窗: Change between pre-therapy (day -14 to -1) and end of therapy (day 43-49)
Reduction of 20 % in the percentage of time spent snoring at levels greater than 40 dB. This will be achieved using WatchPat (510K - K161579) sleep studies
Visual analogue scale (VAS) snoring scores
时间窗: Change between average of pre-therapy (day -14 to day -1), during therapy (day 29 to 42) and post therapy (day 43 to 56)
Visual analogue scale (VAS) of snoring is a subjective assessment of the participant's severity of scoring by their partner on a scale of 1 - 10 (1 being no snoring, 10 being intolerable snoring). This assessment will be done on a daily basis for the 2 weeks prior to intervention, 6 weeks of intervention and 2 weeks post intervention.
次要结局
- Pittsburgh Sleep Quality Index (PSQI)(Change between pre-therapy (day -1) and post therapy (day 56))
- Epworth Sleepiness Scale (ESS)(Change between pre-therapy (day -1) and post therapy (day 56))