Effects of Endoscopic Sinus Surgery on Sleep Disorder in Patients With Chronic Rhinosinusitis With Polyps
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Slow-wave sleep duration
研究概览
简要总结
Nasal polyposis (NP) is a chronic inflammatory disease of the nasal and sinus mucosa leading to protrusion of edematous polyps in the nasal cavity. Prevalence of NP among the chronic rhinosinusitis patients is 25-30 %. NP leads to significant limitations in physical, emotional and social aspects of life of the affected patients. Sleep disorder is frequently reported by those patients with impaired nasal breathing. Till now few studies have objectively assessed the impact of NP on sleep quality. the objectives are to figure out sleep disturbances in NP and to analyze the outcomes of sinus surgery on sleep recovering.
详细描述
the objectives are to figure out sleep disturbances in NP and to analyze the outcomes of sinus surgery on sleep recovering.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Patients who underwent endoscopic sinus surgery for recalcitrant nasal polyposis (failure of a 4-month corticosteroid medical treatment) Social insured patient
- •Patient willing to comply with all procedures of the study and its duration
- •Patient giving consent
排除标准
- •Patients with previous nasal surgery for nasal polyposis
- •Patients with previous continuous positive airway pressure therapy for obstructive sleep apnea
- •Non-coverage by the social security scheme
- •Patient unable to receive informed information
- •Refusal to sign the consent
- •Person deprived of the liberty
- •Person benefiting from a system of legal protection (guardianship…)
研究组 & 干预措施
endoscopic sinus surgery
Single group of patients with nasal polyposis eligible for endoscopic sinus surgery
干预措施: Endoscopic sinus surgery (Procedure)
结局指标
主要结局
Change in Slow-wave sleep duration
时间窗: 1 month before surgery and 3 months postoperatively
Slow-wave sleep duration is measured one month before surgery and 3 months after surgery
次要结局
- change in Apnea-hypopnea index(At 1 month before surgery and at 3 months postoperatively)
- change in Epworth sleepiness scale scores(At 1 month before surgery and at 3 months postoperatively)
- change in total sleep duration(At 1 month before surgery and at 3 months postoperatively)
- Change in the number of brief wakefulness(At 1 month before surgery and at 3 months postoperatively)
- Change in time with oxygen desaturation below 90%(At 1 month before surgery and at 3 months postoperatively)