Sleep Apnea in Type 1 Diabetes : Prevalence, Role of Glycemic Control and Autonomic Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Compare the prevalence of sleep apnea syndrome by polysomnography between type 1 diabetic patients and healthy volunteers
研究概览
简要总结
Sleep apnea syndrome is strongly associated to type 2 diabet, partly and this is partly due to obesity. Treatment of sleep apnea may improve hypertension, cardiovascular risk and in some studies diabetes status. Few data are available for type 1 diabetes but suggest that the prevalence of sleep apnea syndrome may be high. We plan to compare the prevalence of sleep apnea syndrome assessed by polysomnography in a sample of type 1 diabetic patients and a control group matched by age, gender and body mass index. The secondary objective is to determine if the presence of an autonomic neuropathy or poorly controlled diabetes (assessed by glycosylated haemoglobin) may or not contribute to the presence of sleep apnea in the diabetic group.
详细描述
Diagnostic protocol designed to evaluate if if sleep apnea syndrome is more frequent in type 1 diabetes than in general population and therefore deserves to be more systematically suspected and actively diagnosed in this patients. Sleep apnea syndrome is a heavy burden as a matter of quality of life: it is responsible for fatigue, diurnal sleepiness, cognitive impairment, poor and /or non restorative sleep, morning headaches, depressive mood...Adequate treatment provides a rapid and, most of the time, complete relief of these symptoms.
On an other hand, Sleep Apnea is and independent risk factor for cardiovascular mortality and morbidity in young and middle aged subjects, also reversed by treatment. It might be therefore important for type 1 diabetic patients who have already an increased cardiovascular risk to be properly diagnosed for sleep apnea. A systematic screening for sleep apnea is already recommended for patients with type 2 diabetes by experts.
A secondary objective is to determine if the presence of a sleep apnea syndrome in type 1 diabetic patients is associated to an autonomic neuropathy, a poor glycemic control , a poorer quality of life , a poorer quality of sleep, more severe cardiovascular consequences and biological impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •99 Type 1 diabetic patients
- •man or woman aged 18 to 60 years
- •diagnosed since at least a year
- •having signed a consent
- •with in a national insurance scheme
- •and 46 healthy volunteers matched by age , gender and body mass index
- •man or woman aged 18 to 60 years
- •having signed a consent
- •with in a national insurance scheme
排除标准
- •sleep apnea syndrome already known
- •acute respiratory or cardiovascular disease
- •impairment of consciousness
- •cirrhosis
- •hypnotic, opiate or psychotropic drug treatment 2 weeks ago
- •Pregnant or breast-feeding woman
- •Do not speak French
- •Benefiting from a legal protective measure
- •diabet 1 or 2 just for volunteers people
结局指标
主要结局
Compare the prevalence of sleep apnea syndrome by polysomnography between type 1 diabetic patients and healthy volunteers
时间窗: 3 months
Determine if prevalence of the sleep apnea syndrome is more raised at the patient's diabetics of type 1 (DT1) than in the general population and to collect elements to specify the determiners of this association (presence of an autonomous neuropathy and glycemic balance). sleep apnea syndrome as defined by the International Classification of Sleep Disorders 2
次要结局
- Precise if glycemic balance as defined by glycosylated hemoglobin<7% during the last three months is associated or not to sleep apnea syndrome(3 months)
- Precise if the presence of an autonomic neuropathy (positive at 2 tests) is associated or not to sleep apnea syndrome(3 months)
- Compare the patients with or without sleep apnea regarding consequences especially cardiovascular markers and coagulation factors(3 months)
- Precise clinical symptoms in DT1 patients with Sleep apnea syndrome(3 months)
- Determine if the presence of sleep apnea syndrome has an impact upon quality of life and diabetes complications, micro or macroangiopathy(3 months)