Effect of Continuous Positive Airway Pressure Treatment on Nocturnal Glycemia of Patients Having Type 1 Diabetes and Sleep Apnea Syndrome: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- change in mean nocturnal glycemia
研究概览
简要总结
Hypothesis: To address the role of continuous positive airway pressure (CPAP)on nocturnal glycemia in patients having type 1 diabetes and sleep apnea syndrome.
Investigators make the hypothesis that sleep apnea syndrome impacts nocturnal glycemia in type 1 diabetic patients and that continuous positive airway pressure treatment will permit to improve the nocturnal glycemic profile.
Study design: Adult patients with type 1 diabetes will be recruited for an extensive study of sleep habits and assessment of sleep breathing disorders. When patients will present with severe sleep apnea syndrome (apnea-hypopnea index above 30 events/hour) and insufficient glycemic control (HbA1c > 7.5%), they will be randomized in continuous positive airway pressure treatment or sham-continuous positive airway pressure treatment group for three months.
Main outcome: Nocturnal glycemic control will be assessed for 5 days before and after three months of the allocated treatment.
详细描述
Quality of clinical study procedures will be checked by on-site audit.
Patient self-reported past medical history will be checked by reviewing medical records.
Paper case report forms will be used.
For the baseline extensive study of sleep habits, the following data are recorded:
- Self-reported sleep diary (7 days)
- Actimetric device (7 days)
- Munich Chronotype Questionnaire
- 24h-dietary recall
- Salivary collections every 30 minutes between 7:30 pm and 22:00 pm on one night to address the dim light melatonin onset.
- Other questionnaires: Job strain questionnaire, EPICES (precarity questionnaire) and DQOL (diabetes related quality of life)
- Nocturnal oxymetry
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Adult patients with type 1 diabetes
排除标准
- •Pregnant women
- •Patient with acute metabolic disorders during the past three months
- •Shift workers
- •Institutionalized patient
- •Enteral and parenteral nutrition
结局指标
主要结局
change in mean nocturnal glycemia
时间窗: 3 months
Measured from continuous glycemic monitoring system
次要结局
- Changes in sleep duration after intervention(3 months)
- Chang in sleep timing after intervention(3 months)
- Change in daily activity after intervention(3 months)
- Change in mean heart rate after intervention(3 months)
- Change in blood pressure(3 months)
- Change in the variability of nocturnal glycemia(3months)
- Change in HbA1c(3 months)
- Change in mean systolic blood pressure after intervention(3 months)
- Change in mean diastolic blood pressure after intervention(3 months)