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

Overseen By Mrinalini Balki, MD

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Disqualifiers: Renal disease, Liver disease, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

52 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Mrinalini Balki, MD

Principal Investigator

MOUNT SINAI HOSPITAL

Are You a Good Fit for This Trial?

Inclusion Criteria

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)

Participants who give written informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Initial Exam and Measurements

Participants undergo initial exams including subluxation of mandible, snoring questionnaire, thyromental distance, Mallampati score, height, weight, neck extension, neck size, and sleep questionnaire

1 day

1 visit (in-person)

Body Water Measurement

Total body water is measured using Bioelectrical Impedance Analysis (BIA)

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after initial measurements

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bioelectrical Impedance Analysis (BIA)

How Is the Trial Designed?

Group I: Total body water measurement Experimental Treatment 1 Intervention

Total body water will be measured using Bioelectrical Impedance Analysis (BIA).

Who Is Running the Clinical Trial?

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Lead Sponsor

Trials

132

Recruited

11,400+