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

NCT04187612 | Active Not Recruiting

• 1 other identifier: 19-06
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Apnea, Obstructive Sleep; Obesity

Keywords

pregnancy

Outcome Measures

Primary Outcomes (1)

• Presence of sleep apnea

  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.

  12 hours

Secondary Outcomes (10)

• Total body water measurement

  Following consent, this measurement will be done, and will take approximately 30 minutes

• Mallampati score

  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

• 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

Study Arms (1)

Total body water measurement

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

Device: Bioelectrical Impedance Analysis (BIA)

Interventions

Bioelectrical Impedance Analysis (BIA) DEVICE

BIA will be used to determine total body water

Total body water measurement

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Eligible participants will be approached for consent at our high risk maternal and infant program clinic on the day of their regularly scheduled appointment.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Obesity

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mrinalini Balki, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 5, 2019
• Study Start: December 2, 2019
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)