NCT00805974终止不适用
Study of the Relationship Between Sleep Quality and Daytime-Nighttime Variations of Blood Pressure and Plasma Glucose Type I
University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2005年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Polysomnographic measurements during the D0-D1 night spend at the hospital
研究概览
简要总结
The primary objectives are to compare the mean levels of the sleep quality parameters of subjects : with a nocturnal fall of the SBP (Systolic blood pressure), DBP (diastolic blood pressure) and MAP (mean arterial pressure) over of egal to 10% (dipping subjects) and of subjects with a nocturnal fall of SBP, DBP and MAP inferior to 10% (non dipper subjects).
The secondary objectives are :
Establish correlations between:
- The quality of sleep parameters
- The parameters of BP variations between the diurnal and nocturnal periods and the awake periods of sleep defined in reference to polysomnography.
- The glycemia levels on 24h with a glycemic holter. The parameters of the sympathic system activation evaluated in reference to the measure of the baroreflex sensibility during the awake period.
详细描述
It is a prospective monocentric study after a preliminary period of depistage of the sleep abnormalities by oximetry at home. The patient would be hospitalized for two consecutive days (J0, J1). And the following evaluations will be done:
- Nocturnal oxymetric + Epworth questionnaire + clinical questionnaire to detect sleep perturbations at home.
- Blood pressure + heart rate measure
- Ambulatory blood pressure monitoring on 24 hours
- Polysomnographic measurements during the J0-J1 night spend at the hospital.
- Questionnaire of sleep quality and of quality of life.
- Glycemic measurements on 24h (J0-J1).
- Measure of the baroreflex sensibility during the awake period at J1.
- Electrocardiogram
- Biological examinations (blood and urinary).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- 否
入选标准
- •Male and female patients between 18 and 60 years of age
- •Who have given their written consent to participate in this study
- •Who are affiliated to the French social security system
- •Are able to travel to Grenoble University Hospital
- •Type I diabetes in reference to the 1997 criteria (American Diabetes Association) without any recent cetoacidosis or severe hypoglycaemia during the previous month and with a HbA1c < 10% during the previous month.
- •Normal blood pressure or essential hypertension light or moderate (SBP) at rest in the sitting position >= 140 mmHg and < 180 mmHg and/or PAD >= 90 mmHg et < 110 mmHg), with or without treatment.
排除标准
- •Non stabilised diabetes with at least one episode of acidoketosis decompensation or hypoglycemic coma during the previous month.
- •Diabetic nephropathy patent stage 4 with a creatinine > 150 mol / L and / or creatinine clearance <50 ml / min
- •Diabetic nephropathy in evolution
- •Severe hypertension (SBP at rest in the sitting position >= 180 mmHg and/or DBP >= 110 mmHg)
结局指标
主要结局
Polysomnographic measurements during the D0-D1 night spend at the hospital
时间窗: inclusion visit
Ambulatory blood pressure monitoring on 24 hours
时间窗: inclusion visit
次要结局
- Glycemic measurements on 24h (D0-D1).(inclusion visit)
研究者
研究点 (1)
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