Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy (SLEEP)

  • STATUS
    Recruiting
  • End date
    Jun 30, 2024
  • participants needed
    1500
  • sponsor
    The George Washington University Biostatistics Center
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Updated on 30 June 2022
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Summary

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.

Description

Emerging data support a link between sleep disordered breathing (SDB) and adverse pregnancy outcomes. In particular, women with obstructive sleep apnea (OSA) appear to be at increased risk of both hypertensive disorders of pregnancy and gestational diabetes. In the non-pregnant population, OSA is typically treated with continuous positive airway pressure (CPAP) during sleep and has been shown to reduce blood pressure in hypertensive patients. Unfortunately, data on whether maternal and neonatal outcomes could be improved with treatment of OSA during pregnancy are extremely limited. This study aims to address this knowledge gap.

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.

Details
Condition Obstructive Sleep Apnea of Adult, Preeclampsia, Obstetrical Complications
Treatment Continuous positive airway pressure, Sleep Hygiene Control, Sleep Advice Control
Clinical Study IdentifierNCT03487185
SponsorThe George Washington University Biostatistics Center
Last Modified on30 June 2022

Eligibility

 Yes No Not Sure

Inclusion 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 (see Section 3.4.2)
Gestational age at randomization between 14 weeks 0 days and 21 weeks 6 days based on clinical information and evaluation of the earliest ultrasound as described in Gestational Age Determination in Section 3.4.2
Diagnosis with mild to moderate OSA as defined by an AHI score ≥ 5 and <30

Exclusion Criteria

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
Current use of antihypertensive medication because of the difficulty in diagnosing superimposed preeclampsia
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 interventional study that influences preeclampsia, hypertensive disorders of pregnancy, or GDM
Prenatal care or delivery planned at a non-network center where access to 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 randomized may be included
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