Sleep Quality After Nasosinusal Surgery in AERD Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Subjective sleep quality assessed by the Pittsburgh sleep quality index.
研究概览
简要总结
Aspirin exacerbated respiratory disease presents as a triad composed by asthma, eosinophilic rinosinusitis and intolerance to aspirin and NSAIDS. In subjects with chronic rhinosinusitis sleep alterations have been found, with important improvement after surgery, but those alterations and improvements have not been studied in patients diagnosed with AERD who, due to their comorbidities, may present more severe pre surgical symptoms and a more important post-surgical improvement. The investigators aim to study patients with AERD sleep, quality of life and symptoms before surgery, and one, three and six months post-surgery.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AERD patients.
- •Cumbersome nasal polyposis with poor treatment response
排除标准
- •Previously diagnosed sleep disorder.
- •Psychiatric disorder
研究组 & 干预措施
AERD patients
Patients managed with Endoscopic sinus surgery for treatment of AERD.
干预措施: Endoscopic sinus surgery (Procedure)
结局指标
主要结局
Subjective sleep quality assessed by the Pittsburgh sleep quality index.
时间窗: 6 months
Total score in Pittsburgh sleep quality index, basal and after surgery. Total score in Pittsburgh sleep quality index, before and after surgery. The Pittsburgh sleep quality index has a global score in which a higher score indicates a worse sleep quality, with a global score higher than five differentiating those with good and bad sleep quality. In order to obtain the global score, individual questions are grouped in seven components, to which a 0 to 3 score is assigned and all components scores are added. The total range of the global score goes from 0 to 21.
次要结局
- Objective sleep quality assessed by actigraphy.(Basal; 3 and 6 months)
- Asthma symptoms assessed by the Asthma Control Test.(Basal; 1, 3 and 6 months)
- Quality of life assessed by the Asthma Quality of Life Questionnaire(Basal; 1, 3 and 6 months)
- Nasal symptoms assessed by the SNOT - 22(Basal; 1, 3 and 6 months)
研究者
Marcos Alejandro Jimenez Chobillon
Professor
Instituto Nacional de Enfermedades Respiratorias