Obstructive Sleep Apnea Syndrome In Patients Treated For Cancer Of The Upper Aerodigestive Tract : The SAOS-K Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Occurence of obstructive sleep apnea syndrome
研究概览
简要总结
Prospective open-label, non-randomized, monocentric, cohort study, to assess the prevalence and severity of sleep apnea syndrome in patients treated for cancer of the upper aerodigestive tract.
The patient follows a usual course of care including, at the end of the treatment of his cancer of the upper aerodigestive tract, screening for obstructive sleep apnea syndrome at 3 months and 6 months (Epworth score and ventilatory polygraphy)
详细描述
Prospective open-label, non-randomized, monocentric, cohort study, to assess the prevalence and severity of sleep apnea syndrome in patients treated for cancer of the upper aerodigestive tract.
Patients are included in the study when they are hospitalized for panendoscopy. Thereafter, it takes about 1 month to start any treatment. The duration of treatment is estimated at about 5 months (the longest regimen would be induction chemotherapy followed by surgery and adjuvant complementary treatment). After which the patient follows a usual course of care including, at the end of the treatment of his cancer of the upper aerodigestive tract, screening for obstructive sleep apnea syndrome at 3 months and 6 months (Epworth score and ventilatory polygraphy).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •macroscopic lesion suggestive of a cancerous tumour of the upper aerodigestive tract (oral cavity, oropharynx, larynx, hypopharynx, cavum, cervical lymph node metastases with an occult primary cancer)
- •awaiting anatomopathological confirmation
排除标准
- •history of cancer of the upper aerodigestive tract
- •history of known obstructive sleep apnea syndrome
- •cancer of the thyroid, salivary glands, nose and paranasal sinuses
- •patients under guardianship or curatorship
结局指标
主要结局
Occurence of obstructive sleep apnea syndrome
时间窗: 3 months after the end of treatment for cancer of the upper aerodigestive tract
Obstructive sleep apnea syndrome is defined by an apnea-hypopnea index greater than or equal to 15 per hour
次要结局
- Epworth score(at 3 months and 6 months)
- Delay in onset of obstructive sleep apnea syndrome after completion of cancer treatment(during the 6 months follow-up)
- Occurence of obstructive sleep apnea syndrome(6 months after the end of treatment for cancer of the upper aerodigestive tract)