NCT03222193Unknown不适用
Efficacy Study of the Medical Device TRP Snorless™ in the Treatment of Snoring
Tongue Laboratory2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2017年6月16日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Snore Index
研究概览
简要总结
The Tongue Right Positioner (TRP Snorless™) is a medical device designed to restore physiological tongue positions when functioning or at rest and increase tongue muscles tone. Patient wears TRP Snorless™ daily at least 5 hours during night. Published data suggested that TRP Snorless™ increases oropharynx diameter and nasal patency, favouring airflow in upper airways. Independently of patient's adherence to daily myofascial exercises, the TRP Snorless™ treatment should increase tongue muscles' tone and decrease the risk of snoring during sleep.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman ≥ 18 years and ≤ 65 years at the time of signing informed consent
- •Listed as continuous snorer (snoring at least 4 nights/week)
- •Answer "Extremely loud" or "very loud" to question 1 of SBPS at screening
- •Answer "very severe" or "severe" to question 2 of SBPS at screening
- •Answer "extremely" or "quite a bit" to question 3 of SBPS at screening
- •Dated and signed informed consent
排除标准
- •Severe Mandibular retrognathia and micrognathia
- •Narrow and deep palate (less than 3 cm wide)
- •Lack of three consecutive teeth in the area of (15-16-17-18) or (25-26-27-28).
- •Lingual or labial short frenulum (the tongue cannot reach the upper incisors when mouth can be opened for two fingers)
- •Intolerable gag reflex
- •Known nasal septal deviation
- •Neck circumference > 46 cm
- •Patient currently treated for OSA
- •Patient with AHI≥30 events/hour or with AHI>15 and (SFI) Sleep Fragmentation Index > 20
- •Patient currently treated for central sleep apnoea
- •Addiction to alcoholic beverages (5 drinks per day per NIAAA)
- •Under constant pharmacological treatment for depression, anxiety, chronic pain, insomnia
- •Hypertrophy of tonsils
- •Macroglossia
- •Hypertrophy of uvula
- •Primary gastroesophageal reflux
- •Any other pathology preventing subject from complying with the protocol
- •Subject with recent oropharyngeal surgery or likely during the study
- •Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures
- •Pregnancy
- •Patient with severe Chronic Obstructive Pulmonary Disease
- •Asthmatic patient under inhaled corticoid therapy
研究组 & 干预措施
TRP group
Experimental
Snoring subjects treated with the Tongue Right Positioner (TRP) medical device
干预措施: TRP (Device)
结局指标
主要结局
Snore Index
时间窗: 3 months
number of snores \>36 dB per hour of sleep by BresoDx
次要结局
- Mean sound of snoring/night(3 months)
- Maximum sound of snoring/night(3 months)
- Nasal patency(3 months)
- Apnoea Hypopnea Index(3 months)
- Sleep time(3 months)
- Orofacial functional score (NOT-S questionnaire)(3 months)
- Tongue Endurance score(3 months)
- Quality of sleep(3 months)
- Comfort / Safety(3 months)
- Treatment compliance(3 months)
研究者
研究点 (2)
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