The Effect of Continuous Positive Airway Pressure (CPAP) Treatment on Glycemic Control in Gestational Diabetes: A Pilot Randomized-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Average nightly hours of CPAP use
研究概览
简要总结
Clinical trial on effects of continuous positive airway pressure (CPAP) on glucose levels in pregnant patients with sleep-disordered breathing and gestational diabetes
详细描述
Gestational diabetes (GDM), defined as glucose intolerance that is first recognized during pregnancy, is associated with adverse maternal and fetal outcomes. Sleep-disordered breathing (SDB) is characterized by breathing pauses during sleep leading to recurrent arousals and intermittent hypoxia. The resulting increases in sympathetic drive, cortisol and inflammation have been shown to lead to glucose dysregulation. In that SDB is prevalent during pregnancy, SDB may represent a novel risk factor for GDM, as suggested by recent observational studies. No interventional studies evaluating the effects of SDB treatment on GDM outcomes have yet been published.
General Objective: To perform a pilot study to assess the feasibility of conducting a randomized-controlled trial using continuous positive airway pressure (CPAP) to evaluate the effects of SDB treatment on maternal-fetal outcomes in GDM.
Primary Aim of Pilot Study: 1) To assess CPAP adherence in pregnant patients with GDM. Secondary Aims: 2) To assess recruitment and retention rates over ~2 months of treatment 3) To assess adequacy of nasal dilator strips as the control intervention 4) To measure maternal glucose levels to determine sample size calculations for a future large-scale multi-site randomized-controlled trial.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women aged ≥ 18 y referred to the GDM clinic at the McGill University Health Centre
- •>20 weeks and <34 weeks gestational age at time of recruitment
- •Gestational diabetes
- •Sleep-disordered breathing (SDB)
排除标准
- •Pre-gestational type 1 or type 2 diabetes
- •Multiple pregnancy
- •Conception by IVF
- •Prior treatment for SDB
- •severe medical illness
- •Severe SDB (AHI >30) and Epworth Sleepiness Scale >15 or oxygen desaturation index >30 or sustained hypoxia < 80%
- •Habitual sleep duration on average less than 5 hours/night (determined by actigraphy)
- •Cigarette smoking, alcohol consumption or illicit drug use
结局指标
主要结局
Average nightly hours of CPAP use
时间窗: Up to 8 weeks
Calculated over the course of pregnancy, with objective measurement from CPAP device download. CPAP will be initiated at time of diagnosis of sleep apnea after GDM diagnosis, and up until delivery of the baby (expected duration of 6-8 weeks)
次要结局
- Maternal glucose levels(Throughout pregnancy until delivery)
- Recruitment and retention rates in trial(At completion of study (prior to delivery of baby))
研究者
Sushmita Pamidi
Assistant Professor of Medicine
McGill University Health Centre/Research Institute of the McGill University Health Centre
