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:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
NCT ID:
NCT05654259
Eligibility Criteria:
Inclusion Criteria:
* Both obese and non-obese (normal weight) early pregnant women aged ≥18 years old will be permitted to participate in this project.
* No restriction with respect to race and socioeconomic status
* Women with a prior history of complicated pregnancy (i.e., gestational hypertension, preeclampsia, HELLP syndrome, gestational diabetes, preterm birth, intrauterine growth restriction, etc.) will be allowed to participate.
* Obese women with previously diagnosed OSA will be allowed to participate if they are not currently on any recognized treatments such as Continuous Positive Airway Pressure (CPAP), oral appliances or nasal expiratory positive airway pressure.
* Those who have had surgery for OSA in the past will be excluded.
* Women taking low-dose aspirin will be allowed to participate in this project.
Exclusion Criteria:
* Current multiple pregnancy;
* Known major fetal chromosomal or anatomical abnormalities;
* Recurrent miscarriage (three or more);
* Chronic essential hypertension (systolic BP \>140 mmHg and/or diastolic BP \>90 mmHg);
* Any evidence of cardiovascular and pulmonary diseases by history or by physical examination;
* Kidney disease (serum creatinine \>1.5 mg/dL);
* Coagulation disorders;
* Diabetes mellitus (fasting glucose ≥126 mg/dL or 2-hour oral glucose tolerance test glucose level ≥200 mg/dL) or other systemic illness;
* Any evidence of neurological disease;
* Psychiatric disease or psychological disorders;
* History of drug or alcohol abuse within the last 2 years; and
* Given the effects of exercise training on sympathetic neural control, endurance-trained athletes will be excluded. As this project focuses on sleep apnea in pregnancy, Women with other significant sleep disorders such as restless legs syndrome by Rest Leg Syndrome Diagnostic Index and insomnia by the Insomnia Severity Index or Pittsburgh Sleep Quality Index will be excluded; In addition, women who report taking a sleeping aid \>1 time per month will be excluded.
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT05654259
Study Brief:
Protocol Section:
NCT05654259