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临床试验/NCT02245659
NCT02245659已完成不适用

The Effect of Continuous Positive Airway Pressure (CPAP) Treatment on Glycemic Control in Gestational Diabetes: A Pilot Randomized-Controlled Trial

McGill University Health Centre/Research Institute of the McGill University Health Centre2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2015年3月1日最近更新:
适应症

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

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

发起方
McGill University Health Centre/Research Institute of the McGill University Health Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sushmita Pamidi

Assistant Professor of Medicine

McGill University Health Centre/Research Institute of the McGill University Health Centre

研究点 (2)

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