ObesityNCT05654259
Obesity and OSA in Pregnancy
An observational study of Obesity and Obesity, Maternal, run by University of Texas Southwestern Medical Center at 2 sites in United States.
Trial summary
The purposes of this project are 1) to compare the impact of maternal obesity versus excessive gestational weight gain on obstructive sleep apnea (OSA) in obese and non-obese women; 2) to investigate the mechanism(s) by which obesity and OSA increase cardiovascular risk during pregnancy; and 3) to identify… Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Obesity, Obesity, Maternal, Obstructive Sleep Apnea
- How many people
- 116 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Jul 2018to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 64 years
- Women only
- Adult
Study population: Obese and non-obese pregnant women with and without excessive gestational weight gain; Obese and non-obese pregnant women with and without OSA
Who may be able to join
- 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.
Who cannot join
- 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);
Show all 12Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Institute for Exercise and Environment Medicine (IEEM) at Texas Health Presbyterian Hospital
Dallas, Texas, 75231
University of Texas Southwestern Medical Center Dallas
Dallas, Texas, 75390
About this study
Official title: Obesity and Sleep Apnea in Pregnancy
The purposes of this project are 1) to compare the impact of maternal obesity versus excessive gestational weight gain on obstructive sleep apnea (OSA) in obese and non-obese women; 2) to investigate the mechanism(s) by which obesity and OSA increase cardiovascular risk during pregnancy; and 3) to identify biomarker(s) for obesity-related OSA in pregnant women.
Read the detailed description
Aim 1: To test the hypothesis that maternal obesity increases OSA risk but to a greater extent in obese women with excessive gestational weight gain vs. obese women with normal weight gain vs. non-obese women with excessive weight gain. Study team will enroll early pregnant (≤12 weeks of gestation) obese (pre-pregnancy body mass index ≥30 kg/m2) and non-obese (body mass index 18.5-24.9 kg/m2) women and follow participants throughout gestation. In-home sleep testing will be carried out during all phases of pregnancy: early pregnancy (4-12 weeks gestation), late pregnancy (30-34 weeks of gestation) and postpartum (6-10 weeks after delivery). Investigator will compare AHI (primary endpoint), the development or worsening of OSA, and pregnancy outcomes in obese and non-obese women with and without weight gain above the Institute of Medicine (IOM) recommended levels. Various body composition areas, (e.g., neck, waist, or hips) that may be associated with risk for sleep apnea will also be measured.
Aim 2: To test the hypothesis that obesity is associated with sympathetic activation, while OSA magnifies this abnormality during pregnancy. Study team will use the state-of-the-art technique of microneurography to measure resting sympathetic activity (primary endpoint) and sympathetic neural responses to physiological stimulations (e.g., mental stress, exercise and upright posture) during early (<12 weeks) and late (30-34 weeks) pregnancy, and postpartum (6-10 weeks post) in obese women with and without OSA and non-obese women without OSA.
Aim 3: To test the hypothesis that corin content is greater in obese than nonobese women during pregnancy, and it is the greatest in obese pregnant women with OSA. Venous blood samples will be taken in women enrolled in Aim 2 study for measurements of serum corin content (primary endpoint) and pregnancy-specific angiogenic factors such as soluble fms-like tyrosine kinase 1, placental growth factor, and soluble endoglin. The relationships between maternal corin content, pregnancy-specific angiogenic factors, sympathetic activity, and BP will be explored.
- Conditions
- Obesity, Obesity, Maternal, Obstructive Sleep Apnea, Blood Pressure
- Keywords
- obesity, pregnancy, sleep apnea, blood pressure
- Medical subject headings
- Obesity, Pregnancy in Obesity, Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| obese women with normal gestational weight gain | obese women (body mass index ≥30 kg/m2) with weight gain 5-9 kg | |
| obese women excessive gestational weight gain | obese women (body mass index ≥30 kg/m2) with weight gain >9 kg | |
| non-obese women with normal gestational weight gain | non-obese women (body mass index 18.5-24.9 kg/m2) with weight gain 11.5-16 kg | |
| non-obese women with excessive weight gain | non-obese women (body mass index 18.5-24.9 kg/m2) with weight gain >16 kg | |
| obese women with OSA | obese women (body mass index ≥30 kg/m2) with Obstructive Sleep Apnea (OSA) (Apnea and Hypopnea Index (AHI) ≥5 events/hr | |
| obese women without OSA | obese women (body mass index ≥30 kg/m2) without Obstructive Sleep Apnea (OSA) (AHI <5 events/ hr) | |
| non-obese women without OSA | non-obese women without OSA (AHI <5 events/ hr) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea Hypopnea Index (AHI)
The Apnea-Hypopnea Index or Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea as measured by the Watch Pat device. It is represented by the number of apnea and hypopnea events per hour of sleep. The apneas (pauses in breathing) must last for at least 10 seconds and be associated with a decrease in blood oxygenation. A higher AHI value ≥5 indicates more severe sleep apnea
Measured: Early pregnancy (4-12 weeks gestation)
Apnea Hypopnea Index (AHI)
The Apnea-Hypopnea Index or Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea as measured by the Watch Pat device. It is represented by the number of apnea and hypopnea events per hour of sleep. The apneas (pauses in breathing) must last for at least 10 seconds and be associated with a decrease in blood oxygenation. A higher AHI value ≥5 indicates more severe sleep apnea
Measured: Late pregnancy (30-34 weeks of gestation)
Apnea Hypopnea Index (AHI)
The Apnea-Hypopnea Index or Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea as measured by the Watch Pat device. It is represented by the number of apnea and hypopnea events per hour of sleep. The apneas (pauses in breathing) must last for at least 10 seconds and be associated with a decrease in blood oxygenation. A higher AHI value ≥5 indicates more severe sleep apnea
Measured: Post partum (6-10 weeks after delivery)
Resting sympathetic activity
Resting sympathetic activity is measured by microneurography, as expressed as the number of bursts per minute and as the number of bursts per 100 heart beats, to correct for differences in heart rate.
Measured: Early pregnancy (< 12 weeks gestation)
Resting sympathetic activity
Resting sympathetic activity is measured by microneurography, as expressed as the number of bursts per minute and as the number of bursts per 100 heart beats, to correct for differences in heart rate.
Measured: Late pregnancy (30-34 weeks of gestation)
Resting sympathetic activity
Resting sympathetic activity is measured by microneurography, as expressed as the number of bursts per minute and as the number of bursts per 100 heart beats, to correct for differences in heart rate.
Measured: Post partum (6-10 weeks after delivery)
Serum corin content measurement
Serum corin content will be measured by venous blood samples
Measured: Early pregnancy (< 12 weeks gestation)
Serum corin content measurement
Serum corin content will be measured by venous blood samples
Measured: Late pregnancy (30-34 weeks of gestation)
Serum corin content measurement
Serum corin content will be measured by venous blood samples
Measured: Post partum (6-10 weeks after delivery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start11 Jul 2018
- Primary completion30 Jun 2024
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qi Fu, University of Texas Southwestern Medical Center
- Investigators
- Qi Fu, MD, PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654259
- Sponsor's protocol ID
- STU 062018-089
- Status last verified
- Jul 2025
- First submitted
- 8 Dec 2022
- Last updated
- 15 Jul 2025
- Results posted
- 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 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity and Sleep Apnea in Pregnancy
- ClinicalTrials.gov ID
- NCT05654259
- Acronym / sponsor ID
- STU 062018-089
- Conditions
- Obesity, Obesity, Maternal, Obstructive Sleep Apnea, Blood Pressure
- Keywords
- obesity, pregnancy, sleep apnea, blood pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 11 Jul 2018 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 16 Dec 2022 (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.
The purposes of this project are 1) to compare the impact of maternal obesity versus excessive gestational weight gain on obstructive sleep apnea (OSA) in obese and non-obese women; 2) to investigate the mechanism(s) by which obesity and OSA increase cardiovascular risk during pregnancy; and 3) to identify biomarker(s) for obesity-related OSA in pregnant women.
Detailed description
Aim 1: To test the hypothesis that maternal obesity increases OSA risk but to a greater extent in obese women with excessive gestational weight gain vs. obese women with normal weight gain vs. non-obese women with excessive weight gain. Study team will enroll early pregnant (≤12 weeks of gestation) obese (pre-pregnancy body mass index ≥30 kg/m2) and non-obese (body mass index 18.5-24.9 kg/m2) women and follow participants throughout gestation. In-home sleep testing will be carried out during all phases of pregnancy: early pregnancy (4-12 weeks gestation), late pregnancy (30-34 weeks of gestation) and postpartum (6-10 weeks after delivery). Investigator will compare AHI (primary endpoint), the development or worsening of OSA, and pregnancy outcomes in obese and non-obese women with and without weight gain above the Institute of Medicine (IOM) recommended levels. Various body composition areas, (e.g., neck, waist, or hips) that may be associated with risk for sleep apnea will also be measured.
Aim 2: To test the hypothesis that obesity is associated with sympathetic activation, while OSA magnifies this abnormality during pregnancy. Study team will use the state-of-the-art technique of microneurography to measure resting sympathetic activity (primary endpoint) and sympathetic neural responses to physiological stimulations (e.g., mental stress, exercise and upright posture) during early (<12 weeks) and late (30-34 weeks) pregnancy, and postpartum (6-10 weeks post) in obese women with and without OSA and non-obese women without OSA.
Aim 3: To test the hypothesis that corin content is greater in obese than nonobese women during pregnancy, and it is the greatest in obese pregnant women with OSA. Venous blood samples will be taken in women enrolled in Aim 2 study for measurements of serum corin content (primary endpoint) and pregnancy-specific angiogenic factors such as soluble fms-like tyrosine kinase 1, placental growth factor, and soluble endoglin. The relationships between maternal corin content, pregnancy-specific angiogenic factors, sympathetic activity, and BP will be explored.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| obese women with normal gestational weight gain | – | –obese women (body mass index ≥30 kg/m2) with weight gain 5-9 kg |
| obese women excessive gestational weight gain | – | –obese women (body mass index ≥30 kg/m2) with weight gain >9 kg |
| non-obese women with normal gestational weight gain | – | –non-obese women (body mass index 18.5-24.9 kg/m2) with weight gain 11.5-16 kg |
| non-obese women with excessive weight gain | – | –non-obese women (body mass index 18.5-24.9 kg/m2) with weight gain >16 kg |
| obese women with OSA | – | –obese women (body mass index ≥30 kg/m2) with Obstructive Sleep Apnea (OSA) (Apnea and Hypopnea Index (AHI) ≥5 events/hr |
| obese women without OSA | – | –obese women (body mass index ≥30 kg/m2) without Obstructive Sleep Apnea (OSA) (AHI <5 events/ hr) |
| non-obese women without OSA | – | –non-obese women without OSA (AHI <5 events/ hr) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Obese and non-obese pregnant women with and without excessive gestational weight gain; Obese and non-obese pregnant women with and without OSA
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Apnea Hypopnea Index (AHI)
Time frame: Early pregnancy (4-12 weeks gestation)
The Apnea-Hypopnea Index or Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea as measured by the Watch Pat device. It is represented by the number of apnea and hypopnea events per hour of sleep. The apneas (pauses in breathing) must last for at least 10 seconds and be associated with a decrease in blood oxygenation. A higher AHI value ≥5 indicates more severe sleep apnea
Apnea Hypopnea Index (AHI)
Time frame: Late pregnancy (30-34 weeks of gestation)
The Apnea-Hypopnea Index or Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea as measured by the Watch Pat device. It is represented by the number of apnea and hypopnea events per hour of sleep. The apneas (pauses in breathing) must last for at least 10 seconds and be associated with a decrease in blood oxygenation. A higher AHI value ≥5 indicates more severe sleep apnea
Apnea Hypopnea Index (AHI)
Time frame: Post partum (6-10 weeks after delivery)
The Apnea-Hypopnea Index or Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea as measured by the Watch Pat device. It is represented by the number of apnea and hypopnea events per hour of sleep. The apneas (pauses in breathing) must last for at least 10 seconds and be associated with a decrease in blood oxygenation. A higher AHI value ≥5 indicates more severe sleep apnea
Resting sympathetic activity
Time frame: Early pregnancy (< 12 weeks gestation)
Resting sympathetic activity is measured by microneurography, as expressed as the number of bursts per minute and as the number of bursts per 100 heart beats, to correct for differences in heart rate.
Resting sympathetic activity
Time frame: Late pregnancy (30-34 weeks of gestation)
Resting sympathetic activity is measured by microneurography, as expressed as the number of bursts per minute and as the number of bursts per 100 heart beats, to correct for differences in heart rate.
Resting sympathetic activity
Time frame: Post partum (6-10 weeks after delivery)
Resting sympathetic activity is measured by microneurography, as expressed as the number of bursts per minute and as the number of bursts per 100 heart beats, to correct for differences in heart rate.
Serum corin content measurement
Time frame: Early pregnancy (< 12 weeks gestation)
Serum corin content will be measured by venous blood samples
Serum corin content measurement
Time frame: Late pregnancy (30-34 weeks of gestation)
Serum corin content will be measured by venous blood samples
Serum corin content measurement
Time frame: Post partum (6-10 weeks after delivery)
Serum corin content will be measured by venous blood samples
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- 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.
Qi Fu, MD, PhD principal investigator
University of Texas Southwestern Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Obesity, Maternal, run by University of Texas Southwestern Medical Center at 2 sites in United States.
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 6 inclusion and 12 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: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Apnea Hypopnea Index (AHI) (time frame: Early pregnancy (4-12 weeks gestation)). The study lists 9 primary outcomes in all. 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 15 Jul 2025.