Obstructive Sleep Apnea Syndrome After Oropharyngeal Cancer Treatment
研究概览
详细说明
Obstructive sleep apnea syndrome (OSAS) remains poorly documented in head and neck cancer cancer population, who have a higher risk than the general population. OSAS is a risk factor for quality of life impairment and cardiovascular morbidity and mortality.
This study proposes to carry out an OSAS prevalence study among a locally advanced head and neck cancer population, already treated and to compare the consequences of current therapeutic options in sleep quality.The primary research objective will be a prevalence determination in a locally advanced stages treated population of oropharyngeal cancer. Secondary objectives will be the comparison of the prevalence between the surgical group and the radio-chemotherapy group, the research of predictive factors of presenting an OSAS and the precision of the impact on quality of life.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Marseille、法国、13005
- Service d'ORL et de Chirurgie Cervico-Faciale - Hôpital de la Timone, AP-HM
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patient aged over 18 years old, male or female;
- Patient treated for a first oropharyngeal cancer located in upper airways (velum, side walls, back wall, base of tongue, vallecules), locally advanced, rated T3 or T4, whatever the stage N and M0;
- Patient who received curative treatment either surgical (excision and reconstruction free flap) with adjuvant radiotherapy or concurrent chemoradiotherapy;
- Treatment completed at least 12 months prior to study entry;
- Patient whose cancer disease is under control at exam time;
- Subject affiliated to a social security scheme;
- Subject agreeing to participate in the study and who signed the informed consent form.
Exclusion Criteria:
- Minor patient
- No affiliation to a social security scheme (beneficiary or assignee);
- Patient who did not signed the informed consent form
- Patient with neurological disease that can affect the upper airways function
- Patient has already been treated for head and neck cancer;
- Patient has a lesion classified T1 or T2 or M1;
- Patient has received different treatments: surgical resection without reconstruction, only radiotherapy
- Unweaned alcoholic patients
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Treatment for oropharyngeal cancer by surgery
Disease-free patients treated for locally advanced oropharyngeal cancer for over 12 months by surgery
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实验性的:Treatment for oropharyngeal cancer by radio-chemotherapy
Disease-free patients treated for locally advanced oropharyngeal cancer for over 12 months by radio-chemotherapy
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Measuring the index of apneas and hypopneas (IAH), defined by the number of apneas per sleep hour
大体时间:1 day
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For an IAH <10: no Obstructive Sleep Apnea Syndrome (OSAS) For an IAH>30: severe OSAS is diagnosed
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1 day
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
外科手术的临床试验
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St. Joseph's Healthcare HamiltonHamilton Academic Health Sciences Organization完全的
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Seoul National University HospitalJohnson & Johnson Medical Companies完全的