Association of Body Fluid Distribution With Obstructive Sleep Apnea in Pregnant Women With Body Mass Index ≥ 40 kg/m2 - A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Presence of sleep apnea
研究概览
简要总结
Obstructive Sleep apnea (OSA) is a common and underdiagnosed condition in obese pregnant women with serious and life-threatening complications to the mother and baby. The investiators propose that a non-invasive method may be used to detect patients at risk of OSA, giving these women access to the necessary treatment to treat this condition. The method is a estimation of body water, which has been shown to be linked to OSA in the non-pregnant population. Body water is estimated by applying surface electrodes to a participant who is lying down by measuring bioimpedance through body tissues by applying a tiny current between the electrodes. The electrical stimulation is not felt by the participant and has no negative effects on mother or baby.
详细描述
It is already established that the increasingly prevalent condition of obesity is linked to OSA in pregnancy. Obesity is increasingly prevalent This study will evaluate a novel method of screening for OSA in the obese pregnant population, thereby treating this condition reducing the ill effects to mother and fetus.
This will be a prospective observational cohort study. Eligible participants will be approached for consent during their third-trimester antenatal all-day clinic visit. Body water will be measured by connecting electrodes to participants hands, feet and neck whilst lying supine for approximately 15 minutes.
Data on patient demographics, BMI, medical conditions, water body composition and indicators of OSA (breathing pattern and oxygen levels during sleep) will be collected, as well as data from patients' sleep tests as ordered by their physician.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants who give written informed consent
- •Pregnant women in the third trimester of pregnancy
- •Grade III obesity
- •Patients who have prior diagnosis of OSA within the last one year, and non-compliant to treatment such as continuous positive airway pressure (CPAP), or dental appliance
- •Patients suspected to have OSA based on screening questionnaire (see page 2, OSA-Diagnostic tools for further details)
排除标准
- •Fluid overload states including renal disease, liver disease and congestive heart failure
- •Prior history of vascular surgery in the lower limbs such as varicose vein surgery, vascular by-pass surgery or evidence of venous efficiency.
- •Patients with metal implants in lower limbs or spine, due to possible interference with the leg impedance signals. 58
- •Participants with diagnosed OSA treated with Continuous Positive Airway Pressure (CPAP).
- •Patients requiring urgent sleep physician referral (within four weeks) due to serious medical conditions or safety critical-occupations according to the 2011 Canadian Thoracic Society (CTS) guideline 59 e.g. unstable ischemic heart disease, recent cerebrovascular disease.
- •Implantable cardiac devices
研究组 & 干预措施
Total body water measurement
Total body water will be measured using Bioelectrical Impedance Analysis (BIA).
干预措施: Bioelectrical Impedance Analysis (BIA) (Device)
结局指标
主要结局
Presence of sleep apnea
时间窗: 12 hours
The diagnosis of sleep apnea will be made using apnea hypopnea index (AHI). A diagnosis of OSA is present if a person has an AHI ≥5/hour.
次要结局
- Questionnaire related to snoring(Done during initial exam following consent, this exam will take 1-2 minutes)
- Subluxation of mandible beyond maxilla(Done during initial exam following consent, this exam will take 1-2 minutes)
- Neck extension(Done during initial exam following consent, this exam will take 1-2 minutes)
- Total body water measurement(Following consent, this measurement will be done, and will take approximately 30 minutes)
- Weight (kg)(Done during initial exam following consent, this exam will take 1-2 minutes)
- Mallampati score(Done during initial exam following consent, this exam will take 1-2 minutes)
- Questionnaire related to sleep(Done during initial exam following consent, this exam will take 1-2 minutes)
- Neck size(Done during initial exam following consent, this exam will take 1-2 minutes)
- Thyromental distance (cm)(Done during initial exam following consent, this exam will take 1-2 minutes)
- Height (cm)(Done during initial exam following consent, this exam will take 1-2 minutes)