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

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ClinicalTrials.gov Identifier: NCT04187612
Recruitment Status : Suspended (Virtual/telephone appointments for patients due to Covid restrictions have halted this research. We may resume when we have the resources, however the current plan is to publish the data we have so far.)
First Posted : December 5, 2019
Last Update Posted : January 6, 2021
Sponsor:
Information provided by (Responsible Party):
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

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.

Condition or disease Intervention/treatment
Apnea, Obstructive Sleep Obesity Device: Bioelectrical Impedance Analysis (BIA)

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 52 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Association of Body Fluid Distribution With Obstructive Sleep Apnea in Pregnant Women With Body Mass Index ≥ 40 kg/m2 - A Prospective Observational Study
Actual Study Start Date : December 2, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Group/Cohort Intervention/treatment
Total body water measurement
Total body water will be measured using Bioelectrical Impedance Analysis (BIA).
Device: Bioelectrical Impedance Analysis (BIA)
BIA will be used to determine total body water




Primary Outcome Measures :
  1. Presence of sleep apnea [ 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.


Secondary Outcome Measures :
  1. Total body water measurement [ 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)

  2. Mallampati score [ 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.

  3. Thyromental distance (cm) [ 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.

  4. Subluxation of mandible beyond maxilla [ 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.

  5. Neck extension [ 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.

  6. Height (cm) [ 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)

  7. Weight (kg) [ 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)

  8. Neck size [ Time Frame: Done during initial exam following consent, this exam will take 1-2 minutes ]
    Circumference around the neck, measured in centimeters.

  9. Questionnaire related to snoring [ 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.

  10. Questionnaire related to sleep [ 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04187612


Locations
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Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Investigators
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Principal Investigator: Mrinalini Balki, MD MOUNT SINAI HOSPITAL
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Responsible Party: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT04187612    
Other Study ID Numbers: 19-06
First Posted: December 5, 2019    Key Record Dates
Last Update Posted: January 6, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
pregnancy
Additional relevant MeSH terms:
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Apnea
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Apnea Syndromes
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases