BACKGROUND
The pathophysiology of obstructive sleep apnea in pregnancy remains poorly understood
and studies examining the effect of treatment with positive airway pressure on pregnancy
have been limited.
OBJECTIVE
This study aimed to perform a randomized controlled trial of positive airway pressure
treatment for obstructive sleep apnea in pregnancy.
STUDY DESIGN
Participants with a body mass index ≥30 kg/m2 underwent polysomnography at 14 to 20 weeks’ gestation (visit 1) and those with obstructive
sleep apnea (apnea-hypopnea index ≥5 but <50) were enrolled. In phase 1, participants
were randomized to autotitrating positive airway pressure vs sham positive airway
pressure; in phase 2, the sham arm was replaced with a sleep hygiene control. Participants
returned at 28 to 31 weeks’ gestation (visit 2). The mean arterial blood pressure,
uterine artery Doppler pulsatility index, endoglin, soluble FMS-like tyrosine kinase
1 levels, and placental growth factor levels were measured, as well as fasting glucose
and insulin to calculate insulin resistance (homeostatic model assessment for insulin
resistance). The primary outcome was a composite of the uterine artery Doppler pulsatility
index, soluble FMS-like tyrosine kinase 1 to placental growth factor ratio, and the
homeostatic model assessment for insulin resistance. For secondary analyses, each
outcome variable was analyzed independently. Adherence to treatment was examined.
RESULTS
A total of 241 participants completed visit 1, and 89 (37%) had an apnea-hypopnea
index between 5 and 50. Of the those, 51 participants were randomized in phase 1 and
38 in phase 2. There was no significant difference in our primary outcome by treatment
group. In secondary analyses, the uterine artery Doppler pulsatility index was lower
in participants on autotitrating positive airway pressure when compared with sleep
hygiene controls. Otherwise, there were no differences in the mean arterial blood
pressure, angiogenic markers, or metabolic markers in phase 1, phase 2, or across
the entire study. The overall adherence to autotitrating positive airway pressure
therapy was low, but the mean use was greater in phase 2 (0.3±0.6 hours/night vs 1.3±2.3
hours/night; P=.10). For those on active therapy, fasting glucose values decreased as adherence
increased.
CONCLUSION
This randomized controlled trial of autotitrating positive airway pressure in pregnancy
did not find any differences in a composite primary cardiometabolic risk profile between
the treatment groups. Higher autotitrating positive airway pressure adherence was
associated with lower fasting glucose levels. The use of a sham positive airway pressure
control arm in phase1 may have negatively impacted adherence to active treatment.
Key words
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Article info
Publication history
Published online: December 20, 2022
Accepted:
December 14,
2022
Received in revised form:
December 7,
2022
Received:
October 25,
2022
Footnotes
S.R.P. reports receiving grant support through his institution from Bayer Pharmaceuticals, Philips Respironics, Respicardia, and Sommetrics. He also received personal consulting income from Bayer Pharmaceuticals, NovaResp Technologies, Philips Respironics, and Powell Mansfield Inc. The remaining authors report no conflict of interest.
This study received grant funding from the National Institutes of Health and the National Heart, Lung, and Blood Institute under grant number R01-HL120354.
This study, entitled “Sleep Disordered Breathing, Obesity and Pregnancy Study (SOAP),” was registered with ClinicalTrials.gov, under identifier NCT02086448.
Data sharing statement: Will individual participant data be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
What other documents will be available?
Study protocol
When will data be available (start and end dates)?
Beginning 9 months and ending 36 months following article publication.
By what access criteria will data be shared (including with whom, for what types of analyses, and by what mechanism)?
Researchers who provide a methodologically sound proposal. Proposals should be directed to [email protected], To gain access, data requestors will need to execute a Data Use Agreement.
Cite this article as: Facco FL, Wolsk J, Patel SR, et al. A trial of positive airway pressure for the treatment of sleep apnea in pregnancy. Am J Obstet Gynecol MFM 2022;XX:x.ex–x.ex.
Identification
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© 2022 Published by Elsevier Inc.
