NCT04440618Unknown不适用
Prevalence of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) Following Squamous Cell Carcinomas of the Oropharynx Treatment by Combined Chemoradiotherapy
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Prevalence of obstructive sleep apnea hypopnea syndrome after treatment by combined chemoradiotherapy.
研究概览
简要总结
The study's aim is to determinate the prevalence of obstructive sleep apnea hypopnea syndrome after treatment by combined chemoradiotherapy in a locally advanced stages treated population of oropharyngeal cancer. Indeed, the level of knowledge about the consequences of oropharyngeal cancer treatment on sleep quality remains poor but the few studies published on the subject suggest an increased risk of development of OSAHS for these patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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 old
- •Performance Status 0-2
- •Squamous cell carcinoma of the oropharynx treated with concomitant chemoradiotherapy
- •Treatment termination time greater than 6 months at inclusion
- •Tumor classification (American Joint Committee on Cancer 8th) T2-T4 N0-N3
- •Patient in complete remission at inclusion
- •patient's consent's obtained after information
排除标准
- •Previous treatment for upper aerodigestive tract cancer
- •Incomplete radiotherapyTreatment
- •Neurological pathology wich may affect the functions of the upper aerodigestive tract
- •Pregnant or breastfeeding woman
- •Unweaned alcoholism
- •Tracheotomized patient at the time of the study
- •Patient under protection: subjects with guardianship or under law protection
- •No health insurance coverage
结局指标
主要结局
Prevalence of obstructive sleep apnea hypopnea syndrome after treatment by combined chemoradiotherapy.
时间窗: Day 28
Number of patients with obstructive sleep apnea hypopnea syndrome after treatment combined chemoradiotherapy.
次要结局
- Severity of OSAHS as a function of the post-therapeutic delay.(Day 28)
研究者
研究点 (1)
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