NCT04928404Unknown不适用
Barbed Suspension of the Tongue Base for Treatment of Obstructive Sleep Apnea Patients
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- changes in obstructive sleep apnea
研究概览
简要总结
Obstructive sleep apnea syndrome (OSAS) is a common clinical condition in which the throat narrows or collapses repeatedly during sleep, causing obstructive sleep apnea events.
One of the most common sites for collapse during sleep is hypo-pharyngeal space. It was founded in 50% of OSA patients those have moderate and severe apnea.
DeRowe et al invented the Tongue base suspension operation in 1998 for sleep disordered breathing.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI of patients less than 35 kg/m
- •Patients who have symptoms and signs of OSA.
- •Moderate to severe OSAHS confirmed by formal polysomnography (defined as an AHI ≥15).
- •Friedman tongue position III or IV.
- •Documented failure/refusal of attempts of conservative treatment measures (not limited to continuous positive airway pressure).
- •The presence of retrolingual collapse confirmed preoperatively with flexible fiberoptic endoscope during Muller maneuver.
- •Patients have macroglossia as defined by posterior airspace (PAS) of ≤10mm.
排除标准
- •Failure to attend postoperative follow-up polysomnography within 6 months of surgery.
- •Previous surgery to the base of the tongue or other surgical treatment of OSAHS.
- •A history of malignancy or infection of the head and neck region, laryngeal trauma, or other previous oropharyngeal/laryngeal surgery.
- •Patients have retrognanthia sella-nasion-supra mentale (SNB) ≥76º.
- •Huge lymphoid tissue of the tongue and/or lingual tonsil.
结局指标
主要结局
changes in obstructive sleep apnea
时间窗: 3 months after intervention
using polysomnography
次要结局
未报告次要终点
研究者
Mohammed Abd Elmateen Moussa
Otorhinolaryngology specialist
Sohag University
研究点 (2)
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