Apnea, Obstructive SleepNCT04187612
Association of Body Fluid Distribution With Obstructive Sleep Apnea in Pregnant Women With Body Mass Index ≥ 40 kg/m2
An observational study of Apnea, Obstructive Sleep and Obesity, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Apnea, Obstructive Sleep, Obesity
- What is being tested?
- Bioelectrical Impedance Analysis (BIA)
- Type of treatment
- Medical device
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- 2 Dec 2019to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Apnea, Obstructive Sleep, Obesity
- Being tested
- Bioelectrical Impedance Analysis (BIA)
- Keywords
- pregnancy
- Medical subject headings
- Sleep Apnea, Obstructive, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioelectrical Impedance Analysis (BIA)Device
BIA will be used to determine total body water
| Study group | Role | What they receive |
|---|---|---|
| Total body water measurement | Total body water will be measured using Bioelectrical Impedance Analysis (BIA). Receives: Device: Bioelectrical Impedance Analysis (BIA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 hours
Secondary outcomes (10)
Total body water measurement
Total body water will be measured using Bioelectrical Impedance Analysis (BIA)
Measured: Following consent, this measurement will be done, and will take approximately 30 minutes
Mallampati score
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.
Measured: Done during initial exam following consent, this exam will take 1-2 minutes
Thyromental distance (cm)
The distance between the thyroid notch and the tip of the jaw with the head extended is evaluated.
Measured: Done during initial exam following consent, this exam will take 1-2 minutes
Subluxation of mandible beyond maxilla
The patient is asked to extend their mandible beyond the top lip if possible. Scoring is yes or no.
Measured: Done during initial exam following consent, this exam will take 1-2 minutes
Neck extension
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.
Measured: Done during initial exam following consent, this exam will take 1-2 minutes
Height (cm)
Height measured in cm to calculate Body Mass index (BMI)
Measured: Done during initial exam following consent, this exam will take 1-2 minutes
Weight (kg)
Weight measured in kg to calculate Body Mass index (BMI)
Measured: Done during initial exam following consent, this exam will take 1-2 minutes
Neck size
Circumference around the neck, measured in centimeters.
Measured: Done during initial exam following consent, this exam will take 1-2 minutes
Questionnaire related to snoring
Patients will be asked if they snore, if others can hear their snoring and if they are bothered by it. Yes or no answers.
Measured: Done during initial exam following consent, this exam will take 1-2 minutes
Questionnaire related to sleep
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.
Measured: Done during initial exam following consent, this exam will take 1-2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start2 Dec 2019
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apnea, Obstructive SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mrinalini Balki, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187612
- Sponsor's protocol ID
- 19-06
- Status last verified
- Mar 2026
- First submitted
- 26 Nov 2019
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04187612
- Acronym / sponsor ID
- 19-06
- Conditions
- Apnea, Obstructive Sleep, Obesity
- Keywords
- pregnancy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total body water measurement | – | Device: Bioelectrical Impedance Analysis (BIA)Total body water will be measured using Bioelectrical Impedance Analysis (BIA). |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioelectrical Impedance Analysis (BIA)BIA will be used to determine total body water | Device | Total body water measurement |
Primary outcome
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.
10 secondary outcomes
Total body water measurement
Time frame: Following consent, this measurement will be done, and will take approximately 30 minutes
Mallampati score
Time frame: Done during initial exam following consent, this exam will take 1-2 minutes
Thyromental distance (cm)
Time frame: Done during initial exam following consent, this exam will take 1-2 minutes
Subluxation of mandible beyond maxilla
Time frame: Done during initial exam following consent, this exam will take 1-2 minutes
Neck extension
Time frame: Done during initial exam following consent, this exam will take 1-2 minutes
Height (cm)
Time frame: Done during initial exam following consent, this exam will take 1-2 minutes
Weight (kg)
Time frame: Done during initial exam following consent, this exam will take 1-2 minutes
Neck size
Time frame: Done during initial exam following consent, this exam will take 1-2 minutes
Questionnaire related to snoring
Time frame: Done during initial exam following consent, this exam will take 1-2 minutes
Questionnaire related to sleep
Time frame: Done during initial exam following consent, this exam will take 1-2 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mrinalini Balki, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Apnea, Obstructive Sleep and Obesity, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of sleep apnea (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.