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Simple body water test may spot sleep apnea in obese moms-to-be

NCT ID NCT04187612

Knowledge-focused Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether measuring body water with a harmless device can help detect obstructive sleep apnea (OSA) in pregnant women with severe obesity. OSA is common but often missed in this group, and can be dangerous for both mother and baby. Researchers will enroll 52 women in their third trimester to see if body fluid distribution is linked to sleep apnea, potentially offering a simple screening tool.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a simple, non-invasive way to screen for sleep apnea in obese pregnant women, helping prevent complications.
What could go wrong
This is a small observational study, so results may not apply to all pregnant women. The link between body water and sleep apnea is still unproven in pregnancy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 52 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2019

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

16 to 50 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder obstructive sleep apnea syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Apnea, obstructive sleep Obesity

Contacts and locations

Locations

  • Mount Sinai Hospital

    Toronto, Ontario, M5G1X5, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.