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New treatment option for Obstructive Sleep Apnea of Adult
Official title Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy
ClinicalTrials.gov ID: NCT03487185
What this study is testing
- What it's testing
- A randomized controlled trial of 1,500 women to assess whether treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) in pregnancy will result in a reduction in the rate of hypertensive disorders of pregnancy.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred...
- Gestational age at randomization between 14 weeks 0 days and 21 weeks 6 days based on clinical information and evaluation of the earliest ultrasound.
- Diagnosis with mild to moderate OSA as defined by an AHI score ≥ 5 and \<30.
You likely can't join if
- Previously prescribed, current or planned therapy for sleep apnea.
- Age \< 18 years, because the rate of sleep apnea in this population is extremely low.
- Inability to sleep in a stable place with access to the CPAP machine at least 5 nights per week.
- Asthma requiring systemic steroid therapy for more than 14 days within the past 6 months because this population is expected to be unresponsive to...
- Current use of prescribed sleeping pills for insomnia.
- Chronic medical conditions requiring oxygen supplementation (e.g. pulmonary fibrosis, pulmonary hypertension, cystic fibrosis) because this...
See the full eligibility criteria
- Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age.
- Gestational age at randomization between 14 weeks 0 days and 21 weeks 6 days based on clinical information and evaluation of the earliest ultrasound.
- Diagnosis with mild to moderate OSA as defined by an AHI score ≥ 5 and \<30.
- Previously prescribed, current or planned therapy for sleep apnea.
- Age \< 18 years, because the rate of sleep apnea in this population is extremely low.
- Inability to sleep in a stable place with access to the CPAP machine at least 5 nights per week.
- Asthma requiring systemic steroid therapy for more than 14 days within the past 6 months because this population is expected to be unresponsive to CPAP therapy.
- Current use of prescribed sleeping pills for insomnia.
- Chronic medical conditions requiring oxygen supplementation (e.g. pulmonary fibrosis, pulmonary hypertension, cystic fibrosis) because this population is expected to be unresponsive to CPAP therapy.
- Chronic renal disease with serum creatinine \>1.3 mg/dL because the primary outcome would be pre-determined.
- Antiphospholipid antibody syndrome, because it would compromise the primary outcome diagnosis.
- History of medical complications such as:
- Active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes)
- Thrombocytopenia with platelet count \<100,000 because of the difficulty in assessing the primary outcome.
- Active vaginal bleeding (more than spotting) at the time of randomization.
- Known chromosomal, genetic, major malformations or fetal demise, or planned termination of pregnancy because inclusion would compromise evaluation of secondary neonatal outcomes.
- Known major uterine malformations associated with adverse pregnancy outcomes.
- Current use of opiates (heroin, methadone, or other daily opioid use) due to inaccuracy of the home sleep test and inefficiency of CPAP.
- Active drug use, alcohol use, or unstable psychiatric condition.
- Participation in another treatment study that influences preeclampsia, hypertensive disorders of pregnancy, or GDM.
- Prenatal care or delivery planned at a non-network center where access to the complete electronic medical record will not be available to research staff.
- Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not assigned by chance, may be included.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- San Francisco, California, United States
- Chicago, Illinois, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Providence, Rhode Island, United States
- Galveston, Texas, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; San Francisco, California, United States; Chicago, Illinois, United States; New York, New York, United States; Chapel Hill, North Carolina, United States; Cleveland, Ohio, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.