Mount Sinai Hospital
Toronto, Ontario, M5G1X5, Canada
NCT Number: NCT04187612
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.
This study is active but is not currently recruiting participants.
Notify Me16 year–50 year
Female
Observational
Toronto, Ontario, M5G1X5, Canada
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
BIA will be used to determine total body water
Time frame: 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.
Time frame: Following consent, this measurement will be done, and will take approximately 30 minutes
Total body water will be measured using Bioelectrical Impedance Analysis (BIA)
Time frame: Done during initial exam following consent, this exam will take 1-2 minutes
The patient is asked to open their mouth wide and stick out their tongue. Upon observation, the view is classified/scored as Class 1-4. Class one would be least likely to have airway problems and 4 most likely.
Time frame: Done during initial exam following consent, this exam will take 1-2 minutes
The distance between the thyroid notch and the tip of the jaw with the head extended is evaluated.
Time frame: Done during initial exam following consent, this exam will take 1-2 minutes
The patient is asked to extend their mandible beyond the top lip if possible. Scoring is yes or no.
Time frame: Done during initial exam following consent, this exam will take 1-2 minutes
The patient is asked to extend their neck, looking upwards and back, as far as comfortably possible. Scoring is yes if movement is possible, no if extension is not possible.
Time frame: Done during initial exam following consent, this exam will take 1-2 minutes
Height measured in cm to calculate Body Mass index (BMI)
Time frame: Done during initial exam following consent, this exam will take 1-2 minutes
Weight measured in kg to calculate Body Mass index (BMI)
Time frame: Done during initial exam following consent, this exam will take 1-2 minutes
Circumference around the neck, measured in centimeters.
Time frame: Done during initial exam following consent, this exam will take 1-2 minutes
Patients will be asked if they snore, if others can hear their snoring and if they are bothered by it. Yes or no answers.
Time frame: Done during initial exam following consent, this exam will take 1-2 minutes
Patients will be asked if they wake frequently during sleep, if they wake with a choking sensation, and whether they doze off or fall asleep while sitting/talking. Yes or no answers.
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Other
Association of Body Fluid Distribution With Obstructive Sleep Apnea in Pregnant Women With Body Mass Index ≥ 40 kg/m2 - A Prospective Observational Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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