Clinical trial

Association of Body Fluid Distribution With Obstructive Sleep Apnea in Pregnant Women With Body Mass Index ≥ 40 kg/m2

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT04187612

Active, not recruitingNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age16 Years to 50 Years

SexFemale

Healthy volunteersAccepted

ConditionApnea, Obstructive Sleep, Obesity

Full registry criteria

Inclusion Criteria: * 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) Exclusion Criteria: * 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

Treatments and study arms

Bioelectrical Impedance Analysis (BIA)

Device

BIA will be used to determine total body water

Primary outcomes

Presence of sleep apnea12 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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Mount Sinai Hospital🇨🇦 Toronto, Ontario, Canada

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