Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2025-12-26 @ 10:16 PM
NCT ID:
NCT04187612
Eligibility 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
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
16 Years
Maximum Age:
50 Years
Study:
NCT04187612
Study Brief:
Protocol Section:
NCT04187612